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History of Changes for Study: NCT04280705
Adaptive COVID-19 Treatment Trial (ACTT)
Latest version (submitted March 9, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 20, 2020 None (earliest Version on record)
2 February 21, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 February 27, 2020 Study Status and Contacts/Locations
4 March 3, 2020 Contacts/Locations and Study Status
5 March 5, 2020 Contacts/Locations and Study Status
6 March 6, 2020 Contacts/Locations and Study Status
7 March 12, 2020 Contacts/Locations and Study Status
8 March 18, 2020 Contacts/Locations and Study Status
9 March 19, 2020 Contacts/Locations and Study Status
10 March 20, 2020 Outcome Measures, Contacts/Locations, Study Design, Study Description, Eligibility, Arms and Interventions, Study Status and Study Identification
11 March 24, 2020 Contacts/Locations and Study Status
12 March 24, 2020 Contacts/Locations and Study Status
13 March 26, 2020 Contacts/Locations and Study Status
14 April 2, 2020 Contacts/Locations and Study Status
15 April 16, 2020 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Description, Study Status, Eligibility and Study Design
16 April 23, 2020 Contacts/Locations, Study Status, Arms and Interventions and Study Design
17 April 30, 2020 Conditions and Study Status
18 May 6, 2020 Contacts/Locations and Study Status
19 July 7, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
20 July 20, 2020 Document Section and Study Status
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Results Submission Events
21 September 22, 2020 Outcome Measures, Study Status, Document Section and Results
22 November 1, 2020 More Information and Study Status
23 November 13, 2020 Study Status
24 December 5, 2020 Study Description and Study Status
25 March 9, 2022 Contacts/Locations, More Information, Outcome Measures, Eligibility, Conditions and Study Status
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Changes (Merged) for Study: NCT04280705
February 20, 2020 (v1) -- March 9, 2022 (v25)

Changes in: Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Document Section and Results

Open or close this module Study Identification
Unique Protocol ID: 20-0006
Brief Title: Adaptive COVID-19 Treatment Trial Trial (ACTT)
Official Title: A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2020 April 2020
Overall Status: Not yet recruiting Completed
Study Start: March 12, 2020 February 21, 2020
Primary Completion: April 1, 2023 [Anticipated] May 21, 2020 [Actual]
Study Completion: April 1, 2023 [Anticipated] May 21, 2020 [Actual]
First Submitted: February 20, 2020
First Submitted that
Met QC Criteria:
February 20, 2020
First Posted: February 21, 2020 [Actual]
Results First Submitted: September 16, 2020
Results First Submitted that
Met QC Criteria:
September 22, 2020
Results First Posted: September 25, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
February 20, 2020 March 9, 2022
Last Update Posted: February 21, 2020 [Actual] March 14, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adult patients adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 approximately 100 sites globally. The study will be a series of 2-arm comparisons between compare different investigational therapeutic agents and to a placebo control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment will then may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants subjects. An independent data Data and safety monitoring board Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. Randomization will be stratified by: 1) site and 2) severity of illness at enrollment To evaluate the clinical efficacy, severe disease (requiring mechanical ventilation or oxygen, a SpO2 </= 94% or tachypnea (respiratory rate >/= 24 breaths/min)) or mild-moderate disease (SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen)). Subjects will be as assessed daily while hospitalized. Discharged patients will be asked by time to attend study visits at Days 15 recovery, and 29. All subjects will undergo a series of efficacy, safety, and laboratory assessments. The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative as compared to the control arm in patients hospitalized with COVID-19. arm.
Detailed Description:

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adult patients adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 approximately 100 sites globally. The study will be a series of 2-arm comparisons between compare different investigational therapeutic agents and to a placebo control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment will then may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants subjects. An independent data Data and safety monitoring board Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms . Randomization will be stratified by: 1) site and 2) severity of illness at enrollment, severe disease (requiring mechanical ventilation or oxygen, a SpO2 </= 94% or tachypnea (respiratory rate >/= 24 breaths/min)) or mild-moderate disease (SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen)). Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15, and 29. All subjects will undergo a series of efficacy, safety, and laboratory assessments. The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19. The secondary objectives of the study are to 1) evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by clinical severity, hospitalization, and mortality, and 2) evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm .

The initial sample size is projected to be 572 subjects to achieve 400 subjects with a "recovered" status (per the primary objective). The primary analysis will be based on those subjects enrolled in order to 400 recoveries. An additional analysis of the moderate severity subgroup (those with baseline status of "Hospitalized, requiring supplemental oxygen" or "Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care") is also of public health importance. Hence, enrollment will be permitted until the date of April 20, 2020 to ensure 400 recoveries and provide additional data about this important subgroup. With recent enrollment rates, the total sample size may be 600 to over 800.

Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29 as an outpatient. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and OP swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, Day 15 and 29 visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and may also be conducted by phone.

All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized).

The primary outcome is time to recovery by Day 29. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. As little is known about the clinical course of COVID-19, a pilot study will be used for a blinded sample size reassessment.

Contacts:

20-0006 Central Contact

Telephone: 1 (301) 7617948

Email: DMIDClinicalTrials@niaid.nih.gov

Open or close this module Conditions
Conditions: Corona Virus Infection COVID-19
Keywords: Adaptive
COVID-19
Efficacy
Multicenter
novel coronavirus
Safety
ACTT
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 394 [Anticipated] 1062 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator
Placebo
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for the duration of the hospitalization up to a 10 days total course. n= 197. 286.
Placebo
The supplied matching placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.
Experimental: Remdesivir
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for the duration of the hospitalization up to a 10 days total course. n= 197. 286.
Drug: Remdesivir
Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Percentage of subjects reporting each severity rating on the 7-point ordinal scale Time to Recovery
[ Time Frame: Day 15 Day 1 through Day 29 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
2. Time to Recovery by Race
[ Time Frame: Day 1 through Day 29 ]

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
3. Time to Recovery by Ethnicity
[ Time Frame: Day 1 through Day 29 ]

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
4. Time to Recovery by Sex
[ Time Frame: Day 1 through Day 29 ]

Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Secondary Outcome Measures:
1. Change from baseline in alanine transaminase (ALT) Change From Baseline in Alanine Transaminase (ALT)
[ Time Frame: Day 1 through Day 29 Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
2. Change from baseline in aspartate transaminase (AST) Change From Baseline in Aspartate Transaminase (AST)
[ Time Frame: Day 1 through Day 29 Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
3. Change from baseline in creatinine Change From Baseline in Creatinine
[ Time Frame: Day 1 through Day 29 Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
4. Change from baseline in glucose Change From Baseline in Glucose
[ Time Frame: Day 1 through Day 29 Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
5. Change from baseline in hemoglobin Change From Baseline in Hemoglobin
[ Time Frame: Day 1 through Day 29 Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
6. Change from baseline in platelets Change From Baseline in Platelets
[ Time Frame: Day 1 through Day 29 Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
7. Cumulative incidence of severe adverse events (AEs) Change From Baseline in Prothrombin Time (PT)
[ Time Frame: Day 1 through Day 29 Days 1, 3, 5, 8, 11, 15 and 29 ]

Severe AEs include Grade 3 and 4 AEs. Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
8. Change From Baseline in Total Bilirubin
[ Time Frame: Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
9. Change From Baseline in White Blood Cell Count (WBC)
[ Time Frame: Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
10. Change From Baseline in Neutrophils
[ Time Frame: Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
11. Change From Baseline in Lymphocytes
[ Time Frame: Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
12. Change From Baseline in Monocytes
[ Time Frame: Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
13. Change From Baseline in Basophils
[ Time Frame: Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
14. Change From Baseline in Eosinophils
[ Time Frame: Days 1, 3, 5, 8, 11, 15 and 29 ]

Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
8 15. Change in National Early Warning Score (NEWS) from baseline From Baseline
[ Time Frame: Day 3 through Day 29 Days 1, 3, 5, 8, 11, 15, 22, and 29 ]

The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
9 . Discontinuation temporary suspension of infusions
[ Time Frame: Day 1 through Day 29 ]

For any reason.
10 . Duration of hospitalization
[ Time Frame: Day 1 through Day 29 ]

Measured in days.
11 . Duration of new mechanical ventilation
[ Time Frame: Day 1 through Day 29 ]

12 . Number of ventilator free days
[ Time Frame: Day 1 to Day 29 ]

13 16. Subject clinical status using ordinal scale Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
[ Time Frame: Day 3 through Day 29 Day 1 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1 8) Death; 2 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 5) Hospitalized, requiring supplemental oxygen; 5 4) Hospitalized, not requiring supplemental oxygen oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities activities and/or requiring home oxygen; 7 1) Not hospitalized, no limitations on activities.
17. Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
[ Time Frame: Day 3 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
18. Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
[ Time Frame: Day 5 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
19. Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
[ Time Frame: Day 8 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
20. Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
[ Time Frame: Day 11 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
14 21. Number of oxygenation free days Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
[ Time Frame: Day 1 to Day 29 Day 15 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
15 22. Time to an improvement of one category from admission using an ordinal scale Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
[ Time Frame: Day 1 through Day 29 Day 22 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1 8) Death; 2 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 5) Hospitalized, requiring supplemental oxygen; 5 4) Hospitalized, not requiring supplemental oxygen oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities activities and/or requiring home oxygen; 7 1) Not hospitalized, no limitations on activities.
16 23. Mean change in the ordinal scale from baseline Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
[ Time Frame: Day 3 through Day 29 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1 8) Death; 2 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 5) Hospitalized, requiring supplemental oxygen; 5 4) Hospitalized, not requiring supplemental oxygen oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities activities and/or requiring home oxygen; 7 1) Not hospitalized, no limitations on activities.
24. Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
[ Time Frame: Day 1 through Day 29 ]

Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
17 25. Cumulative incidence of serious adverse events (SAEs) Percentage of Participants Reporting Serious Adverse Events (SAEs)
[ Time Frame: Day 1 through Day 29 ]

An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
18 26. Subject mortality Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
[ Time Frame: Day 1 through Day 29 10 ]

Date and cause of death (if applicable). Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.
19 27. Incidence of new oxygen use Duration of Hospitalization
[ Time Frame: Day 1 through Day 29 ]

Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
28. Duration of New Non-invasive Ventilation or High Flow Oxygen Use
[ Time Frame: Day 1 through Day 29 ]

Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
20 29. Duration of new oxygen use Duration of New Oxygen Use
[ Time Frame: Day 1 through Day 29 ]

Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

.

30. Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
[ Time Frame: Day 1 through Day 29 ]

Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
21 31. Change from baseline in total bilirubin Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use
[ Time Frame: Day 1 through Day 29 ]

New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.
32. Percentage of Participants Requiring New Oxygen Use
[ Time Frame: Day 1 through Day 29 ]

The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
22 33. Change from baseline in white blood cell count Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
[ Time Frame: Day 1 through Day 29 ]

The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
34. Mean Change in the Ordinal Scale
[ Time Frame: Day 1, 3, 5, 8, 11, 15, 22, and 29 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
35. 14-day Participant Mortality
[ Time Frame: Day 1 through Day 15 ]

The mortality rate was determined as the proportion of participants who died by study Day 15.
23 36. Incidence of new mechanical ventilation 29-day Participant Mortality
[ Time Frame: Day 1 through Day 29 ]

The mortality rate was determined as the proportion of participants who died by study Day 29.
37. Time to an Improvement by at Least One Category Using an Ordinal Scale
[ Time Frame: Day 1 through Day 29 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
38. Time to an Improvement of at Least Two Categories Using an Ordinal Scale
[ Time Frame: Day 1 through Day 29 ]

The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
24 39. Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
[ Time Frame: Day 1 through Day 29 ]

The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 99 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Admitted to a hospital with symptoms suggestive of COVID-19 infection.
  2. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  3. Understands Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
  4. Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol.
  5. Male or non-pregnant female adult >/= > / = 18 years of age at time of enrollment.
  6. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following:
    1. PCR positive in sample collected < 72 hours prior to randomization; OR

      Exclusion Criteria:

    2. PCR positive in sample collected >/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
  7. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization.
  8. Illness of any duration, and at least one of the following:
    1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
    2. SpO2 < / = 94% on room air, OR
    3. Requiring supplemental oxygen, OR
    4. Requiring mechanical ventilation.
    5. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
    6. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR
    7. Requiring mechanical ventilation and/or supplemental oxygen.
  9. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception for not including hormonal contraception from the duration time of the study (acceptable methods will be determined by the site). screening through Day 29.
  10. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.

Exclusion Criteria:

  1. Alanine transaminase/aspartate transaminase Transaminase (ALT / ) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
  2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) < 30) Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
  3. Pregnancy or breast feeding.
  4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
  5. Allergy to any study medication.
Open or close this module Contacts/Locations
Central Contact Person: Andre Kalil
Telephone: 14025598650
Email: akalil@unmc.edu
Locations: United States, Alabama
University of Alabama at Birmingham School of Medicine - Infectious Disease
Birmingham, Alabama, United States, 35233
United States, California
University of California San Diego Health - Jacobs Medical Center
La Jolla, California, United States, 29037
University of California Los Angeles Medical Center - Westwood Clinic
Los Angeles, California, United States, 90095
University of California Irvine Medical Center - Infectious Disease
Orange, California, United States, 92868-3298
VA Palo Alto Health Care System - Infectious Diseases
Palo Alto, California, United States, 94304-1207
University of California Davis Medical Center - Internal Medicine - Infectious Disease
Sacramento, California, United States, 95817-1460
Naval Medical Center San Diego - Infectious Disease Clinic
San Diego, California, United States, 92314
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine
San Francisco, California, United States, 94110-2859
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
Stanford, California, United States, 94305-2200
Cedars Sinai Medical Center
West Hollywood, California, United States, 90048-1804
United States, Colorado
Denver Health Division of Hospital Medicine - Main Campus
Denver, Colorado, United States, 80204
United States, Georgia
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, United States, 30030-1705
United States, Illinois
Northwestern Hospital - Infectious Disease
Chicago, Illinois, United States, 60611-2908
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
Chicago, Illinois, United States, 60612
United States, Louisiana
Southeast Louisiana Veterans Health Care System - Section of Infectious Diseases
New Orleans, Louisiana, United States, 70119
United States, Maryland
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States, 21201-1509
Johns Hopkins Hospital - Medicine - Infectious Diseases
Baltimore, Maryland, United States, 21287-0005
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section
Bethesda, Maryland, United States, 20892-1504
United States, Massachusetts
Massachusetts General Hospital - Infectious Diseases
Boston, Massachusetts, United States, 02114-2621
University of Massachusetts Medical School - Infectious Diseases and Immunology
Worcester, Massachusetts, United States, 01655-0002
United States, Minnesota
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine
Minneapolis, Minnesota, United States, 55455-0341
United States, Missouri
Saint Louis University - Center for Vaccine Development
Saint Louis, Missouri, United States, 63104-1015
United States, Nebraska
University of Nebraska Medical Center - Infectious Diseases
Omaha, Nebraska, United States, 68198-5400 68105
United States, New York
Montefiore Medical Center - Infectious Diseases
Bronx, New York, United States, 10467-2401
New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology
New York, New York, United States, 10016-6402
University of Rochester Medical Center - Vaccine Research Unit
Rochester, New York, United States, 14642-0001
United States, North Carolina
Duke Human Vaccine Institute - Duke Vaccine and Trials Unit
Durham, North Carolina, United States, 27704
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania - Infectious Diseases
Philadelphia, Pennsylvania, United States, 19104-4238
United States, Tennessee
Vanderbilt University Medical Center - Infectious Diseases
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch - Division of Infectious Disease
Galveston, Texas, United States, 77555-0435
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States, 77030-3411
University of Texas Health Science Center at San Antonio - Infectious Diseases
San Antonio, Texas, United States, 78229-3901
United States, Virginia
University of Virginia - Acute Care Surgery
Charlottesville, Virginia, United States, 22908-0816
Naval Medical Center Portsmouth - Infectious Disease Division
Portsmouth, Virginia, United States, 23708
United States, Washington
EvergreenHealth Infectious Disease Service
Kirkland, Washington, United States, 98034
The University of Washington - Virology Research Clinic
Seattle, Washington, United States, 98104
Providence Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Madigan Army Medical Center - Infectious Disease Clinic
Tacoma, Washington, United States, 98431
Denmark
University of Copenhagen - Centre of Excellence for Health, Immunity and Infections (CHIP) - Department of Infectious Diseases
Copenhagen, Denmark, 2100
Germany
Universitatsklinikum Koeln Klinik I fur Innere Medizin Klinisches Studienzentrum fur Infektiologie I
Cologne, Germany, 50937
Universitätsklinikum Frankfurt -Medizinische Klinik II - Infektiologie
Frankfurt, Germany, 60590
Germany, Nordrhein-Westfalen
Universitatsklinikum Bonn, Medizinische Klinik I - Bereich Infektiologie/HIV der Medizinischen Klinik
Bonn, Nordrhein-Westfalen, Germany, 53127
Greece
Medical School of Athens University - Evangelismos Hospital - Department of Critical Care and Pulmonary Services
Athens, Greece, GR-10675
Greece, Central Macedonia
AHEPA University Hospital - 1st Department of Internal Medicine
Thessaloniki, Central Macedonia, Greece, P.O. 54636
Japan
National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center
Tokyo, Japan, 162-8655
Korea, Republic of, Gyeonggi-do
Seoul National University Bundang Hospital - Division of Infectious Diseases
Bundang-gu Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Korea, Republic of, Jongno-gu
Seoul National University Hospital
Seoul, Jongno-gu, Korea, Republic of, 03080
Mexico
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán - Departamento de Infectologia
Mexico City, Mexico, 14080
Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío Villegas
Mexico City, Mexico, 14080
Singapore
National Centre for Infectious Diseases
Singapore, Singapore, 308442
Spain, Cataluña
Hospital Clinic Barcelona, Servicio de Salud Internacional
Barcelona, Cataluña, Spain, 08036
Hospital Germans Trias i Pujol - Servei Malalties Infeccioses
Barcelona, Cataluña, Spain, 08916
United Kingdom
John Radcliffe Hospital
Headington, Oxford, United Kingdom, OX3 9DU
United Kingdom, Brighton
Royal Sussex County Hospital - Department of Intensive Care Medicine
East Sussex, Brighton, United Kingdom, BN2 5BE
United Kingdom, London, City Of
Saint Thomas' Hospital - Directorate of Infection
London, London, City Of, United Kingdom, SE1 7EH
United Kingdom, Newcastle Upon Tyne
Royal Victoria Infirmary - Department of Infectious Diseases
Level 6, Ward 19, Newcastle Upon Tyne, United Kingdom, NE1 4LP
United Kingdom, West Yorkshire
St. James's University Hospital - Infectious Diseases
Leeds, West Yorkshire, United Kingdom, LS9 7TK
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: April 2, 2020
Uploaded: 09/16/2020 16:07
File Name: Prot_001.pdf
Statistical Analysis Plan
Document Date: May 29, 2020
Uploaded: 09/16/2020 16:08
File Name: SAP_002.pdf
Informed Consent Form
Document Date: March 4, 2020
Uploaded: 07/20/2020 15:36
File Name: ICF_000.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 21FEB2020 and 20APR2020.
Pre-assignment Details
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description

200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course.

Placebo: The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.

200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.

Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.

Period Title: Overall Study
Started 521 541
Received Treatment 517 531
Completed 508 517
Not Completed 13 24
Reason Not Completed
Enrolled but not treated 4 10
Physician Decision 1 0
Withdrawal by Subject 7 9
Adverse Event 0 4
Transferred to another hospital 1 1
Open or close this module Baseline Characteristics
Arm/Group Title Placebo Remdesivir Total
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. Total of all reporting groups
Overall Number of Baseline Participants 521 541 1062
Baseline Analysis Population Description [Not Specified]
Age, Categorical
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed 521 Participants 541 Participants 1062 Participants
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
324
62.19%
354
65.43%
678
63.84%
>=65 years
197
37.81%
187
34.57%
384
36.16%
Age, Continuous
Mean ( Standard Deviation)
Unit of measure: years
Number Analyzed 521 Participants 541 Participants 1062 Participants
59.2 (15.4) 58.6 (14.6) 58.9 (15.0)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed 521 Participants 541 Participants 1062 Participants
Female
189
36.28%
189
34.94%
378
35.59%
Male
332
63.72%
352
65.06%
684
64.41%
Ethnicity (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed 521 Participants 541 Participants 1062 Participants
Hispanic or Latino
116
22.26%
134
24.77%
250
23.54%
Not Hispanic or Latino
373
71.59%
382
70.61%
755
71.09%
Unknown or Not Reported
32
6.14%
25
4.62%
57
5.37%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed 521 Participants 541 Participants 1062 Participants
American Indian or Alaska Native
3
0.58%
4
0.74%
7
0.66%
Asian
56
10.75%
79
14.6%
135
12.71%
Native Hawaiian or Other Pacific Islander
2
0.38%
2
0.37%
4
0.38%
Black or African American
117
22.46%
109
20.15%
226
21.28%
White
287
55.09%
279
51.57%
566
53.3%
More than one race
1
0.19%
2
0.37%
3
0.28%
Unknown or Not Reported
55
10.56%
66
12.2%
121
11.39%
Region of Enrollment
Measure Type: Number
Unit of measure: participants
Number Analyzed 521 Participants 541 Participants 1062 Participants
Greece
19 14 33
South Korea
12 9 21
Singapore
7 9 16
United States
410 427 837
Japan
7 8 15
Denmark
21 22 43
Mexico
6 4 10
United Kingdom
21 25 46
Germany
6 7 13
Spain
12 16 28
Disease severity [1]
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed 521 Participants 541 Participants 1062 Participants
Mild-to-moderate disease severity
50
9.6%
55
10.17%
105
9.89%
Severe disease severity
471
90.4%
486
89.83%
957
90.11%
 
[1] Measure Description: 

Mild-moderate disease: SpO2 > 94% and respiratory rate < 24 breaths/min without supplemental oxygen.

Severe disease: requiring mechanical ventilation, requiring oxygen, a SpO2 = 94% on room air, or tachypnea (respiratory rate = 24 breaths/min).

Open or close this module Outcome Measures
1. Primary Outcome:
Title Time to Recovery
Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
15 (13 to 18) 10 (9 to 11)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
Comments[Not specified]
Type of Statistical Test Superiority
Comments[Not specified]
Statistical Test of HypothesisP-Value <0.001
Comments[Not specified]
Method Log Rank
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.29
Confidence Interval (2-sided) 95%
1.12 to 1.49
Estimation Comments [Not specified]
2. Primary Outcome:
Title Time to Recovery by Race
Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
   
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
 
Asian
Number Analyzed Participants Participants
12.0 (9.0 to 15.0) 11.0 (9.0 to 15.0)
Black or African American
Number Analyzed Participants Participants
15.0 (10.0 to 21.0) 10.0 (7.0 to 16.0)
White
Number Analyzed Participants Participants
15.0 (12.0 to 19.0) 9.0 (8.0 to 12.0)
Other
Number Analyzed Participants Participants
24.0 (15.0 to NA) [1] 9.0 (6.0 to 14.0)
[1] NA Explanation: A large number of participants at the median estimate resulted in little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) was unable to compute an upper confidence limit.
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for Asian participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.07
Confidence Interval (2-sided) 95%
0.73 to 1.58
Estimation Comments [Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for Black or African American participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.25
Confidence Interval (2-sided) 95%
0.91 to 1.72
Estimation Comments [Not specified]
Statistical Analysis 3
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for White participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.29
Confidence Interval (2-sided) 95%
1.06 to 1.57
Estimation Comments [Not specified]
Statistical Analysis 4
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for Race of Other participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.68
Confidence Interval (2-sided) 95%
1.10 to 2.58
Estimation Comments [Not specified]
3. Primary Outcome:
Title Time to Recovery by Ethnicity
Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized and for whom Ethnicity was reported
   
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 489 516
Median (95% Confidence Interval)
Unit of Measure: Days
 
Not Hispanic or Latino
Number Analyzed Participants Participants
15.0 (13.0 to 18.0) 10.0 (8.0 to 12.0)
Hispanic or Latino
Number Analyzed Participants Participants
12.5 (9.0 to 22.0) 10.0 (7.0 to 14.0)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for Not Hispanic or Latino participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.31
Confidence Interval (2-sided) 95%
1.10 to 1.55
Estimation Comments [Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for Hispanic or Latino participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.28
Confidence Interval (2-sided) 95%
0.94 to 1.73
Estimation Comments [Not specified]
4. Primary Outcome:
Title Time to Recovery by Sex
Description Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
   
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
 
Male
Number Analyzed Participants Participants
15.0 (12.0 to 19.0) 9.0 (8.0 to 12.0)
Female
Number Analyzed Participants Participants
15.0 (12.0 to 19.0) 10.0 (8.0 to 13.0)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for Male participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.30
Confidence Interval (2-sided) 95%
1.09 to 1.56
Estimation Comments [Not specified]
Statistical Analysis 2
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
CommentsThis analysis is for Female participants
Type of Statistical Test Superiority
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.31
Confidence Interval (2-sided) 95%
1.03 to 1.66
Estimation Comments [Not specified]
5. Secondary Outcome:
Title Change From Baseline in Alanine Transaminase (ALT)
Description Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 465
Mean (Standard Deviation)
Unit of Measure: Units/Liter (U/L)
Day 3
14.3 (88) 2.9 (31.5)
Day 5
23.1 (70.6) 10.8 (55.8)
Day 8
24.2 (79.7) 8.9 (54.2)
Day 11
27.7 (89.8) 3.4 (48.4)
Day 15
28.1 (110.1) 1.7 (47.4)
Day 29
-3.9 (62.2) -6.8 (43.7)
6. Secondary Outcome:
Title Change From Baseline in Aspartate Transaminase (AST)
Description Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 438 445
Mean (Standard Deviation)
Unit of Measure: Units/Liter (U/L)
Day 3
13.7 (90.7) -2.0 (29.1)
Day 5
12.8 (66.2) 6.0 (58.9)
Day 8
13.1 (114.6) 1.1 (55.9)
Day 11
11.5 (78.8) -0.3 (51.7)
Day 15
4.2 (73.0) -2.3 (60.4)
Day 29
-18.4 (47.2) -14.0 (52.2)
7. Secondary Outcome:
Title Change From Baseline in Creatinine
Description Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 475 482
Mean (Standard Deviation)
Unit of Measure: milligrams/deciliter (mg/dL)
Day 3
0.037 (0.517) 0.038 (0.569)
Day 5
-0.695 (17.552) 0.075 (0.762)
Day 8
-0.882 (19.637) 0.158 (0.951)
Day 11
1.173 (15.440) 0.236 (1.057)
Day 15
-1.239 (22.755) 0.319 (2.147)
Day 29
-1.863 (26.093) 0.075 (0.644)
8. Secondary Outcome:
Title Change From Baseline in Glucose
Description Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 456 459
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 3
-0.2 (53.4) -3.0 (49.4)
Day 5
6.3 (60.2) 2.1 (63.8)
Day 8
2.2 (73.3) 3.2 (68.0)
Day 11
1.0 (70.1) -0.1 (77.4)
Day 15
-2.8 (64.4) -2.9 (75.4)
Day 29
-13.5 (96.8) -11.7 (75.4)
9. Secondary Outcome:
Title Change From Baseline in Hemoglobin
Description Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 475 475
Mean (Standard Deviation)
Unit of Measure: grams/deciliter (g/dL)
Day 3
-0.52 (1.10) -0.69 (5.36)
Day 5
-0.83 (1.22) -0.99 (5.83)
Day 8
-1.22 (1.42) -0.49 (6.54)
Day 11
-1.66 (1.67) -1.29 (1.93)
Day 15
-1.51 (2.02) -1.02 (3.04)
Day 29
-1.02 (2.38) -1.21 (7.91)
10. Secondary Outcome:
Title Change From Baseline in Platelets
Description Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 471 474
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3
39.3 (60.0) 46.0 (62.6)
Day 5
76.5 (100.5) 90.1 (99.9)
Day 8
111.8 (137.4) 130.8 (128.1)
Day 11
109.3 (149.3) 101.0 (145.0)
Day 15
96.5 (154.2) 71.1 (133.3)
Day 29
32.7 (124.2) 39.6 (107.4)
11. Secondary Outcome:
Title Change From Baseline in Prothrombin Time (PT)
Description Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 339 352
Mean (Standard Deviation)
Unit of Measure: seconds
Day 3
-0.18 (4.28) 0.44 (5.22)
Day 5
-0.30 (4.72) 1.15 (5.72)
Day 8
0.01 (2.59) 1.43 (3.89)
Day 11
0.86 (7.85) 1.88 (5.68)
Day 15
0.34 (4.33) -0.03 (4.25)
Day 29
-0.28 (3.20) -0.63 (3.37)
12. Secondary Outcome:
Title Change From Baseline in Total Bilirubin
Description Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 451 456
Mean (Standard Deviation)
Unit of Measure: mg/dL
Day 3
0.08 (1.25) -0.04 (0.75)
Day 5
0.58 (4.13) -0.03 (1.03)
Day 8
0.22 (2.56) 0.01 (1.38)
Day 11
0.23 (2.79) 0.07 (1.48)
Day 15
0.00 (1.80) 0.09 (1.54)
Day 29
-0.17 (1.65) -0.12 (1.77)
13. Secondary Outcome:
Title Change From Baseline in White Blood Cell Count (WBC)
Description Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 474 475
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3
18.691 (424.837) -18.970 (301.944)
Day 5
9.886 (566.175) -28.209 (412.615)
Day 8
27.223 (479.095) -45.997 (602.461)
Day 11
1.967 (16.042) -34.702 (574.065)
Day 15
56.311 (620.551) -70.884 (600.011)
Day 29
-0.898 (17.801) 0.251 (3.987)
14. Secondary Outcome:
Title Change From Baseline in Neutrophils
Description Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 459
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3
9.429 (260.345) -8.093 (135.068)
Day 5
4.177 (362.782) -15.067 (216.532)
Day 8
17.916 (305.321) -28.179 (365.099)
Day 11
3.010 (27.502) -21.773 (354.025)
Day 15
36.024 (389.093) -39.988 (333.088)
Day 29
-1.269 (7.160) -0.840 (3.666)
15. Secondary Outcome:
Title Change From Baseline in Lymphocytes
Description Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 459
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3
5.883 (118.740) -7.847 (131.548)
Day 5
4.064 (141.580) -11.723 (167.428)
Day 8
8.006 (137.149) -15.455 (194.111)
Day 11
0.393 (1.371) -12.016 (183.060)
Day 15
14.793 (159.583) -23.836 (218.653)
Day 29
0.668 (1.406) 0.743 (0.664)
16. Secondary Outcome:
Title Change From Baseline in Monocytes
Description Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 463 458
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3
2.448 (41.304) -2.940 (46.752)
Day 5
1.498 (57.686) -2.628 (39.329)
Day 8
2.324 (36.626) -3.645 (48.636)
Day 11
0.383 (0.744) -2.539 (43.454)
Day 15
6.475 (69.019) -8.738 (74.365)
Day 29
0.125 (0.485) 0.117 (0.340)
17. Secondary Outcome:
Title Change From Baseline in Basophils
Description Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 455 452
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3
0.020 (0.257) 0.005 (0.043)
Day 5
0.038 (0.501) 0.005 (0.370)
Day 8
0.196 (3.132) 0.005 (0.368)
Day 11
0.024 (0.042) 0.028 (0.053)
Day 15
0.158 (1.913) -0.058 (1.028)
Day 29
0.040 (0.073) 0.029 (0.054)
18. Secondary Outcome:
Title Change From Baseline in Eosinophils
Description Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Time Frame Days 1, 3, 5, 8, 11, 15 and 29
Outcome Measure Data
Analysis Population Description
The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 456 455
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/liter
Day 3
0.634 (10.614) 0.016 (0.727)
Day 5
0.666 (11.977) -0.066 (2.807)
Day 8
0.596 (8.875) -0.221 (4.108)
Day 11
0.093 (0.190) -0.088 (2.973)
Day 15
1.992 (20.365) -0.420 (5.378)
Day 29
0.241 (0.324) 0.211 (0.267)
19. Secondary Outcome:
Title Change in National Early Warning Score (NEWS) From Baseline
Description The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
Time Frame Days 1, 3, 5, 8, 11, 15, 22, and 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 499 502
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3
0.1 (2.8) -0.3 (2.6)
Day 5
0.3 (3.3) -0.4 (2.9)
Day 8
-0.3 (3.8) -0.5 (3.2)
Day 11
-0.3 (4.1) -0.5 (3.5)
Day 15
-1.4 (4.2) -1.7 (3.6)
Day 22
-1.4 (4.0) -1.7 (4.1)
Day 29
-3.2 (4.0) -3.3 (3.2)
20. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 1
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
0 (0 to 1) 0 (0 to 1)
Hospitalized, on invasive mech. vent. or ECMO
30 (26 to 34) 24 (21 to 28)
Hospitalized, on non-invasive vent./high flow O2
19 (16 to 22) 18 (15 to 21)
Hospitalized, requiring supplemental oxygen
39 (35 to 43) 43 (39 to 47)
Hospitalized, not on O2, requiring ongoing care
12 (10 to 15) 14 (11 to 17)
Hospitalized, not requiring O2, no longer req care
0 (0 to 1) 0 (0 to 1)
Not hospitalized, limit on activities/req home O2
0 (0 to 1) 0 (0 to 1)
Not hospitalized, no limitations on activities
0 (0 to 1) 0 (0 to 1)
No clinical status score reported - Hospitalized
0 (0 to 1) 1 (0 to 2)
No clinical status score reported - Discharged
0 (0 to 1) 0 (0 to 1)
No clinical status score reported - Discontinued
1 (0 to 2) 1 (0 to 2)
21. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 3
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
1 (1 to 3) 1 (0 to 2)
Hospitalized, on invasive mech. vent. or ECMO
36 (32 to 40) 28 (25 to 32)
Hospitalized, on non-invasive vent./high flow O2
17 (14 to 21) 16 (13 to 19)
Hospitalized, requiring supplemental oxygen
32 (29 to 37) 37 (33 to 41)
Hospitalized, not on O2, requiring ongoing care
12 (9 to 15) 13 (10 to 16)
Hospitalized, not requiring O2, no longer req care
0.4 (0 to 1) 0.2 (0 to 1)
Not hospitalized, limit on activities/req home O2
0 (0 to 1) 0 (0 to 1)
Not hospitalized, no limitations on activities
0 (0 to 1) 0.4 (0 to 1)
No clinical status score reported - Hospitalized
0 (0 to 1) 0 (0 to 1)
No clinical status score reported - Discharged
0.2 (0 to 1) 2 (1 to 4)
No clinical status score reported - Discontinued
1 (0 to 2) 2 (1 to 4)
22. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 5
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
2 (1 to 4) 2 (1 to 4)
Hospitalized, on invasive mech. vent. or ECMO
37 (33 to 41) 28 (24 to 32)
Hospitalized, on non-invasive vent./high flow O2
14 (12 to 18) 12 (9 to 15)
Hospitalized, requiring supplemental oxygen
26 (23 to 30) 28 (24 to 31)
Hospitalized, not on O2, requiring ongoing care
11 (8 to 13) 15 (12 to 18)
Hospitalized, not requiring O2, no longer req care
1 (0 to 2) 1 (0 to 2)
Not hospitalized, limit on activities/req home O2
0 (0 to 1) 0.2 (0 to 1)
Not hospitalized, no limitations on activities
0.2 (0 to 1) 0 (0 to 1)
No clinical status score reported - Hospitalized
0 (0 to 1) 0 (0 to 1)
No clinical status score reported - Discharged
7 (5 to 9) 12 (9 to 15)
No clinical status score reported - Discontinued
2 (1 to 3) 3 (2 to 5)
23. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 8
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
7 (5 to 9) 3 (2 to 5)
Hospitalized, on invasive mech. vent. or ECMO
33 (29 to 37) 24 (21 to 28)
Hospitalized, on non-invasive vent./high flow O2
9 (7 to 12) 9 (7 to 12)
Hospitalized, requiring supplemental oxygen
15 (13 to 19) 17 (14 to 21)
Hospitalized, not on O2, requiring ongoing care
10 (8 to 13) 11 (9 to 14)
Hospitalized, not requiring O2, no longer req care
1 (1 to 3) 1 (1 to 3)
Not hospitalized, limit on activities/req home O2
0 (0 to 1) 0.2 (0 to 1)
Not hospitalized, no limitations on activities
0.2 (0 to 1) 0 (0 to 1)
No clinical status score reported - Hospitalized
0 (0 to 1) 0.4 (0 to 1)
No clinical status score reported - Discharged
22 (19 to 26) 30 (27 to 34)
No clinical status score reported - Discontinued
2 (1 to 3) 4 (2 to 5)
24. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 11
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
8 (6 to 11) 4 (3 to 6)
Hospitalized, on invasive mech. vent. or ECMO
28 (25 to 32) 22 (19 to 26)
Hospitalized, on non-invasive vent./high flow O2
7 (5 to 10) 6 (4 to 8)
Hospitalized, requiring supplemental oxygen
13 (10 to 16) 11 (9 to 14)
Hospitalized, not on O2, requiring ongoing care
6 (5 to 9) 7 (5 to 9)
Hospitalized, not requiring O2, no longer req care
2 (1 to 4) 2 (1 to 4)
Not hospitalized, limit on activities/req home O2
0.4 (0 to 1) 0.4 (0 to 1)
Not hospitalized, no limitations on activities
0.2 (0 to 1) 0 (0 to 1)
No clinical status score reported - Hospitalized
0 (0 to 1) 0 (0 to 1)
No clinical status score reported - Discharged
33 (29 to 37) 44 (40 to 48)
No clinical status score reported - Discontinued
2 (1 to 4) 4 (3 to 6)
25. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 15
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
11 (9 to 14) 6 (5 to 9)
Hospitalized, on invasive mech. vent. or ECMO
22 (19 to 26) 15 (13 to 19)
Hospitalized, on non-invasive vent./high flow O2
4 (3 to 6) 4 (3 to 6)
Hospitalized, requiring supplemental oxygen
11 (9 to 14) 10 (8 to 13)
Hospitalized, not on O2, requiring ongoing care
6 (5 to 9) 7 (5 to 9)
Hospitalized, not requiring O2, no longer req care
2 (1 to 3) 3 (2 to 4)
Not hospitalized, limit on activities/req home O2
17 (14 to 21) 19 (16 to 22)
Not hospitalized, no limitations on activities
22 (19 to 26) 29 (25 to 33)
No clinical status score reported - Hospitalized
0 (0 to 1) 0 (0 to 1)
No clinical status score reported - Discharged
2 (1 to 3) 2 (1 to 4)
No clinical status score reported - Discontinued
3 (2 to 4) 5 (3 to 7)
26. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 22
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
13 (10 to 16) 9 (7 to 12)
Hospitalized, on invasive mech. vent. or ECMO
14 (12 to 18) 9 (7 to 12)
Hospitalized, on non-invasive vent./high flow O2
2 (1 to 4) 2 (1 to 4)
Hospitalized, requiring supplemental oxygen
8 (6 to 11) 5 (4 to 8)
Hospitalized, not on O2, requiring ongoing care
5 (4 to 8) 6 (4 to 8)
Hospitalized, not requiring O2, no longer req care
1 (0 to 2) 1 (1 to 3)
Not hospitalized, limit on activities/req home O2
18 (15 to 22) 19 (16 to 23)
Not hospitalized, no limitations on activities
32 (29 to 37) 39 (35 to 43)
No clinical status score reported - Hospitalized
0 (0 to 1) 0 (0 to 1)
No clinical status score reported - Discharged
2 (1 to 4) 3 (2 to 5)
No clinical status score reported - Discontinued
4 (2 to 6) 6 (4 to 8)
Completed study without reporting score
0 (0 to 1) 0.2 (0 to 1)
27. Secondary Outcome:
Title Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Time Frame Day 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Death at or before study Visit
15 (12 to 18) 11 (8 to 14)
Hospitalized, on invasive mech. vent. or ECMO
9 (7 to 11) 6 (4 to 8)
Hospitalized, on non-invasive vent./high flow O2
2 (1 to 3) 1 (0 to 2)
Hospitalized, requiring supplemental oxygen
4 (3 to 6) 4 (3 to 6)
Hospitalized, not on O2, requiring ongoing care
3 (2 to 5) 3 (2 to 5)
Hospitalized, not requiring O2, no longer req care
1 (0 to 2) 1 (0 to 2)
Not hospitalized, limit on activities/req home O2
19 (16 to 23) 20 (17 to 23)
Not hospitalized, no limitations on activities
36 (32 to 41) 46 (42 to 50)
No clinical status score reported - Hospitalized
0.2 (0 to 1) 0 (0 to 1)
No clinical status score reported - Discharged
3 (2 to 5) 1 (1 to 3)
No clinical status score reported - Discontinued
5 (3 to 7) 7 (5 to 9)
Completed study without reporting score
3 (2 to 4) 2 (1 to 4)
28. Secondary Outcome:
Title Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
Description Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The safety population includes all participants with available data post baseline, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 516 532
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57 (52.8 to 61.5) 51 (47.0 to 55.6)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
Comments[Not specified]
Type of Statistical Test Superiority
Comments[Not specified]
Statistical Test of HypothesisP-Value 0.058
Comments[Not specified]
Method Barnard's Exact Test
Comments[Not specified]
29. Secondary Outcome:
Title Percentage of Participants Reporting Serious Adverse Events (SAEs)
Description An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The safety population includes all participants with available data post baseline, analyzed as treated.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 516 532
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32 (27.7 to 35.7) 24 (20.9 to 28.3)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
Comments[Not specified]
Type of Statistical Test Superiority
Comments[Not specified]
Statistical Test of HypothesisP-Value 0.010
Comments[Not specified]
Method Barnard's Exact Test
Comments[Not specified]
30. Secondary Outcome:
Title Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Description Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.
Time Frame Day 1 through Day 10
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Discontinued due to discharge
30 (26 to 34) 41 (37 to 45)
Discontinued due to death
4 (2 to 6) 3 (2 to 5)
Any infusions halted or slowed
2 (1 to 4) 2 (1 to 4)
Missed any maintenance dose
21 (18 to 25) 16 (13 to 19)
31. Secondary Outcome:
Title Duration of Hospitalization
Description Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputation for participants who died
17 (8 to 28) 12 (6 to 28)
Restricted to participants who did not die
14 (7 to 27) 10 (5 to 21)
32. Secondary Outcome:
Title Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Description Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The analysis population is restricted to randomized participants who were not on non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 64 52
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died
4 (2 to 23.5) 3 (1 to 10.5)
Among participants who did not die
3 (2 to 6) 3 (1 to 6)
33. Secondary Outcome:
Title Duration of New Oxygen Use
Description

Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die

.

Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 28 27
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died
5.5 (1 to 15) 4 (2 to 12)
Among participants who did not die
3 (1 to 13) 3.5 (2 to 5.5)
34. Secondary Outcome:
Title Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Description Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 82 52
Median (Inter-Quartile Range)
Unit of Measure: Days
Including imputations for participants who died
23 (12 to 28) 21.5 (9 to 28)
Among participants who did not die
16 (9 to 24) 14 (5 to 26)
35. Secondary Outcome:
Title Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use
Description New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The analysis population is restricted to randomized participants who were not on non-invasive or high-flow oxygen at baseline.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 266 307
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24 (19 to 30) 17 (13 to 22)
36. Secondary Outcome:
Title Percentage of Participants Requiring New Oxygen Use
Description The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The analysis population is restricted to randomized participants not requiring oxygen at baseline.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 63 75
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44 (33 to 57) 36 (26 to 47)
37. Secondary Outcome:
Title Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Description The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 364 402
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23 (19 to 27) 13 (10 to 17)
38. Secondary Outcome:
Title Mean Change in the Ordinal Scale
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
Time Frame Day 1, 3, 5, 8, 11, 15, 22, and 29
Outcome Measure Data
Analysis Population Description
The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward. Clinical scores of 8 were carried forward from the date of death for participants who died.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 518 533
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 3
0.2 (0.6) 0.1 (0.6)
Day 5
0.1 (0.9) 0.0 (0.8)
Day 8
0.0 (0.1) -0.2 (1.0)
Day 11
-0.1 (1.3) -0.3 (1.1)
Day 15
-1.4 (2.3) -1.9 (2.1)
Day 22
-1.9 (2.5) -2.4 (2.2)
Day 29
-2.3 (2.6) -2.7 (2.3)
39. Secondary Outcome:
Title 14-day Participant Mortality
Description The mortality rate was determined as the proportion of participants who died by study Day 15.
Time Frame Day 1 through Day 15
Outcome Measure Data
Analysis Population Description
The ITT population consists of all participants as randomized.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.12 (0.09 to 0.15) 0.07 (0.05 to 0.09)
40. Secondary Outcome:
Title 29-day Participant Mortality
Description The mortality rate was determined as the proportion of participants who died by study Day 29.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The ITT population includes all participants as randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0.15 (0.12 to 0.19) 0.11 (0.09 to 0.15)
41. Secondary Outcome:
Title Time to an Improvement by at Least One Category Using an Ordinal Scale
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The ITT population includes all participants as randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
9 (8 to 11) 7 (6 to 8)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
Comments[Not specified]
Type of Statistical Test Superiority
Comments[Not specified]
Statistical Test of HypothesisP-Value 0.002
Comments[Not specified]
Method Log Rank
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.23
Confidence Interval (2-sided) 95%
1.08 to 1.41
Estimation Comments [Not specified]
42. Secondary Outcome:
Title Time to an Improvement of at Least Two Categories Using an Ordinal Scale
Description The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The ITT population includes all participants as randomized
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
14 (13 to 15) 11 (10 to 13)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
Comments[Not specified]
Type of Statistical Test Superiority
Comments[Not specified]
Statistical Test of HypothesisP-Value <0.001
Comments[Not specified]
Method Log Rank
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.29
Confidence Interval (2-sided) 95%
1.12 to 1.48
Estimation Comments [Not specified]
43. Secondary Outcome:
Title Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
Description The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Time Frame Day 1 through Day 29
Outcome Measure Data
Analysis Population Description
The ITT population includes all participants as randomized.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
Overall Number of Participants Analyzed 521 541
Median (95% Confidence Interval)
Unit of Measure: Days
12 (10 to 15) 8 (7 to 9)
Statistical Analysis 1
Statistical Analysis OverviewComparison Group Selection Placebo, Remdesivir
Comments[Not specified]
Type of Statistical Test Superiority
Comments[Not specified]
Statistical Test of HypothesisP-Value <0.001
Comments[Not specified]
Method Log Rank
Comments[Not specified]
Method of EstimationEstimation Parameter Cox Proportional Hazard
Estimated Value 1.27
Confidence Interval (2-sided) 95%
1.10 to 1.46
Estimation Comments [Not specified]
Open or close this module Adverse Events
 
Time Frame Grade 3 and 4 serious and non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29.
Adverse Event Reporting Description Given the nature of severity of the underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. In addition, any Grade 2 or higher, suspected drug-related hypersensitivity reaction was to be reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
 
Arm/Group Title Placebo Remdesivir
Arm/Group Description 200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for up to a 10 days total course. 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course.
All-Cause Mortality
  Placebo Remdesivir
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 77 / 521 ( 14.78%) 59 / 541 ( 10.91%)
Serious Adverse Events
  Placebo Remdesivir
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 163 / 516 ( 31.59%) 131 / 532 ( 24.62%)
Blood and lymphatic system disorders
Anaemia ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Coagulopathy ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Febrile neutropenia ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Cardiac disorders
Acute coronary syndrome ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Acute myocardial infarction ∗ A 1 / 516 ( 0.19%) 1 1 / 532 ( 0.19%) 1
Arrhythmia ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Atrial fibrillation ∗ A 1 / 516 ( 0.19%) 2 5 / 532 ( 0.94%) 6
Cardiac arrest ∗ A 7 / 516 ( 1.36%) 7 10 / 532 ( 1.88%) 10
Cardiac failure ∗ A 1 / 516 ( 0.19%) 1 1 / 532 ( 0.19%) 1
Cardiac tamponade ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Cardio-respiratory arrest ∗ A 3 / 516 ( 0.58%) 3 1 / 532 ( 0.19%) 1
Cardiogenic shock ∗ A 2 / 516 ( 0.39%) 2 0 / 532 ( 0%) 0
Myocardial infarction ∗ A 4 / 516 ( 0.78%) 4 0 / 532 ( 0%) 0
Palpitations ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Pulseless electrical activity ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Supraventricular tachycardia ∗ A 3 / 516 ( 0.58%) 3 0 / 532 ( 0%) 0
Ventricular fibrillation ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Ventricular tachycardia ∗ A 0 / 516 ( 0%) 0 2 / 532 ( 0.38%) 2
Gastrointestinal disorders
Diarrhoea ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Duodenal perforation ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Gastrointestinal haemorrhage ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Haematemesis ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Intestinal ischaemia ∗ A 0 / 516 ( 0%) 0 3 / 532 ( 0.56%) 3
Peptic ulcer haemorrhage ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Small intestinal obstruction ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Small intestinal perforation ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
General disorders
Chest pain ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Death ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Multiple organ dysfunction syndrome ∗ A 3 / 516 ( 0.58%) 3 5 / 532 ( 0.94%) 5
Pyrexia ∗ A 2 / 516 ( 0.39%) 2 1 / 532 ( 0.19%) 1
Hepatobiliary disorders
Hepatitis ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Ischaemic hepatitis ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Immune system disorders
Drug hypersensitivity ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Infections and infestations
Bacteraemia ∗ A 2 / 516 ( 0.39%) 2 1 / 532 ( 0.19%) 1
Bacterial sepsis ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
COVID-19 ∗ A 5 / 516 ( 0.97%) 5 2 / 532 ( 0.38%) 2
COVID-19 pneumonia ∗ A 2 / 516 ( 0.39%) 2 1 / 532 ( 0.19%) 1
Catheter bacteraemia ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Endocarditis bacterial ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Gangrene ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Infectious pleural effusion ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Pneumonia ∗ A 2 / 516 ( 0.39%) 2 0 / 532 ( 0%) 0
Sepsis ∗ A 2 / 516 ( 0.39%) 2 1 / 532 ( 0.19%) 1
Septic shock ∗ A 15 / 516 ( 2.91%) 15 8 / 532 ( 1.5%) 8
Staphylococcal bacteraemia ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Urinary tract infection ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Injury, poisoning and procedural complications
Hip fracture ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Infusion related reaction ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Procedural pneumothorax ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Investigations
Blood creatinine increased ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Glomerular filtration rate decreased ∗ A 2 / 516 ( 0.39%) 3 5 / 532 ( 0.94%) 5
Haemoglobin decreased ∗ A 2 / 516 ( 0.39%) 2 1 / 532 ( 0.19%) 1
Lymphocyte count decreased ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Oxygen saturation decreased ∗ A 1 / 516 ( 0.19%) 1 1 / 532 ( 0.19%) 1
Metabolism and nutrition disorders
Acidosis ∗ A 1 / 516 ( 0.19%) 1 1 / 532 ( 0.19%) 1
Decreased appetite ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Dehydration ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Hypernatraemia ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Hyponatraemia ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Musculoskeletal and connective tissue disorders
Myalgia ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Myopathy ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Pain in extremity ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Nervous system disorders
Cerebellar infarction ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Cerebral haemorrhage ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Cerebrovascular accident ∗ A 1 / 516 ( 0.19%) 1 3 / 532 ( 0.56%) 3
Depressed level of consciousness ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Encephalopathy ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Haemorrhagic transformation stroke ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Hemiparesis ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Intensive care unit acquired weakness ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Ischaemic stroke ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Seizure ∗ A 1 / 516 ( 0.19%) 1 2 / 532 ( 0.38%) 2
Subarachnoid haemorrhage ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Psychiatric disorders
Mental status changes ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Psychotic disorder ∗ A 1 / 516 ( 0.19%) 1 0 / 532 ( 0%) 0
Renal and urinary disorders
Acute kidney injury ∗ A 12 / 516 ( 2.33%) 12 7 / 532 ( 1.32%) 7
Renal failure ∗ A 5 / 516 ( 0.97%) 5 2 / 532 ( 0.38%) 2
Renal impairment ∗ A 3 / 516 ( 0.58%) 3 1 / 532 ( 0.19%) 1
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome ∗ A 5 / 516 ( 0.97%) 5 7 / 532 ( 1.32%) 7
Acute respiratory failure ∗ A 14 / 516 ( 2.71%) 14 8 / 532 ( 1.5%) 8
Chronic respiratory failure ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Dyspnoea ∗ A 1 / 516 ( 0.19%) 1 3 / 532 ( 0.56%) 3
Haemoptysis ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Hypoxia ∗ A 4 / 516 ( 0.78%) 4 4 / 532 ( 0.75%) 4
Pneumonia aspiration ∗ A 2 / 516 ( 0.39%) 2 4 / 532 ( 0.75%) 4
Pneumothorax ∗ A 5 / 516 ( 0.97%) 5 5 / 532 ( 0.94%) 5
Pulmonary embolism ∗ A 4 / 516 ( 0.78%) 4 5 / 532 ( 0.94%) 5
Pulmonary haemorrhage ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Respiratory disorder ∗ A 2 / 516 ( 0.39%) 2 0 / 532 ( 0%) 0
Respiratory distress ∗ A 11 / 516 ( 2.13%) 11 6 / 532 ( 1.13%) 6
Respiratory failure ∗ A 58 / 516 ( 11.24%) 59 35 / 532 ( 6.58%) 36
Skin and subcutaneous tissue disorders
Subcutaneous emphysema ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Surgical and medical procedures
Endotracheal intubation ∗ A 9 / 516 ( 1.74%) 9 6 / 532 ( 1.13%) 6
Mechanical ventilation ∗ A 3 / 516 ( 0.58%) 3 1 / 532 ( 0.19%) 1
Vascular disorders
Deep vein thrombosis ∗ A 1 / 516 ( 0.19%) 1 1 / 532 ( 0.19%) 1
Embolism venous ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Hypotension ∗ A 7 / 516 ( 1.36%) 7 4 / 532 ( 0.75%) 4
Peripheral artery occlusion ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Shock ∗ A 4 / 516 ( 0.78%) 4 5 / 532 ( 0.94%) 5
Shock haemorrhagic ∗ A 0 / 516 ( 0%) 0 1 / 532 ( 0.19%) 1
Indicates events were collected by non-systematic methods.
ATerm from vocabulary, MedDRA (23.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
  Placebo Remdesivir
 Affected / At Risk (%)# Events Affected / At Risk (%)# Events
Total 295 / 516 ( 57.17%) 276 / 532 ( 51.88%)
Blood and lymphatic system disorders
Anaemia † A 52 / 516 ( 10.08%) 58 42 / 532 ( 7.89%) 52
Lymphopenia † A 30 / 516 ( 5.81%) 34 13 / 532 ( 2.44%) 15
General disorders
Pyrexia † A 32 / 516 ( 6.2%) 37 38 / 532 ( 7.14%) 52
Investigations
Aspartate aminotransferase increased † A 33 / 516 ( 6.4%) 35 18 / 532 ( 3.38%) 19
Blood creatinine increased † A 36 / 516 ( 6.98%) 41 31 / 532 ( 5.83%) 33
Blood glucose increased † A 27 / 516 ( 5.23%) 31 39 / 532 ( 7.33%) 45
Glomerular filtration rate decreased † A 74 / 516 ( 14.34%) 81 55 / 532 ( 10.34%) 59
Haemoglobin decreased † A 62 / 516 ( 12.02%) 69 48 / 532 ( 9.02%) 51
Lymphocyte count decreased † A 54 / 516 ( 10.47%) 63 44 / 532 ( 8.27%) 56
Metabolism and nutrition disorders
Hyperglycaemia † A 34 / 516 ( 6.59%) 43 34 / 532 ( 6.39%) 36
Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA (23.0)
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact:
Name/Official Title:
John Beigel, MD
Organization:
Organization:NIAID
Phone:
3014519881
Email:
jbeigel@niaid.nih.gov

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