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History of Changes for Study: NCT04280705
Adaptive COVID-19 Treatment Trial
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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Study NCT04280705
Submitted Date:  February 21, 2020 (v2)
Open or close this module Study Identification
Unique Protocol ID: 20-0006 20-0006
Brief Title: Adaptive COVID-19 Treatment Trial Adaptive COVID-19 Treatment Trial
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 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 February 2020
Overall Status: RecruitingRecruiting
Study Start: February 21, 2020 February 21, 2020
Primary Completion: April 1, 2023 [Anticipated] April 1, 2023 [Anticipated]
Study Completion: April 1, 2023 [Anticipated] April 1, 2023 [Anticipated]
First Submitted: February 20, 2020 February 20, 2020
First Submitted that
Met QC Criteria:		 February 20, 2020 February 20, 2020
First Posted: February 21, 2020 [Actual] February 21, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:		 February 21, 2020 February 21, 2020
Last Update Posted: February 25, 2020 [Actual] February 25, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: YesYes
U.S. FDA-regulated Device: NoNo
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 diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 sites globally. The study will be a series of 2-arm comparisons between different investigational therapeutic agents and a placebo. 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, this treatment will then become the control arm for comparison(s) with new experimental treatment(s). 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. An independent data and 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. 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 diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 sites globally. The study will be a series of 2-arm comparisons between different investigational therapeutic agents and a placebo. 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, this treatment will then become the control arm for comparison(s) with new experimental treatment(s). 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. An independent data and 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.
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 diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 sites globally. The study will be a series of 2-arm comparisons between different investigational therapeutic agents and a placebo. 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, this treatment will then become the control arm for comparison(s) with new experimental treatment(s). 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. An independent data and 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. 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 diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to 50 sites globally. The study will be a series of 2-arm comparisons between different investigational therapeutic agents and a placebo. 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, this treatment will then become the control arm for comparison(s) with new experimental treatment(s). 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. An independent data and 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.
Open or close this module Conditions
Conditions: Corona Virus Infection Corona Virus Infection
Keywords: Adaptive
COVID-19
Efficacy
Multicenter
novel coronavirus
Safety 		Adaptive
COVID-19
Efficacy
Multicenter
novel coronavirus
Safety
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 2Phase 2
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: Double (Participant, Investigator)Double (Participant, Investigator)
Allocation: RandomizedRandomized
Enrollment: 394 [Anticipated] 394 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo for the duration of the hospitalization up to a 10 days total course. n=197.
Placebo
The supplied matching placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients.
Experimental: Remdesivir
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir for the duration of the hospitalization up to a 10 days total course. n=197.
 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
Primary Outcome Measures:
1. Percentage of subjects reporting each severity rating on the 7-point ordinal scale
[ Time Frame: 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: 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. 		Percentage of subjects reporting each severity rating on the 7-point ordinal scale
[ Time Frame: 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: 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.
Secondary Outcome Measures:
1. Change from baseline in alanine transaminase (ALT)
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in alanine transaminase (ALT)
[ Time Frame: Day 1 through Day 29 ]
2. Change from baseline in aspartate transaminase (AST)
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in aspartate transaminase (AST)
[ Time Frame: Day 1 through Day 29 ]
3. Change from baseline in creatinine
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in creatinine
[ Time Frame: Day 1 through Day 29 ]
4. Change from baseline in glucose
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in glucose
[ Time Frame: Day 1 through Day 29 ]
5. Change from baseline in hemoglobin
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in hemoglobin
[ Time Frame: Day 1 through Day 29 ]
6. Change from baseline in platelets
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in platelets
[ Time Frame: Day 1 through Day 29 ]
7. Change from baseline in total bilirubin
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in total bilirubin
[ Time Frame: Day 1 through Day 29 ]
8. Change from baseline in white blood cell count
[ Time Frame: Day 1 through Day 29 ]

 Change from baseline in white blood cell count
[ Time Frame: Day 1 through Day 29 ]
9. Change in National Early Warning Score (NEWS) from baseline
[ Time Frame: Day 3 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. 		Change in National Early Warning Score (NEWS) from baseline
[ Time Frame: Day 3 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.
10. Cumulative incidence of 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. 		Cumulative incidence of 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.
11. Cumulative incidence of severe adverse events (AEs)
[ Time Frame: Day 1 through Day 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. 		Cumulative incidence of severe adverse events (AEs)
[ Time Frame: Day 1 through Day 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.
12. Discontinuation temporary suspension of infusions
[ Time Frame: Day 1 through Day 29 ]

For any reason. 		Discontinuation temporary suspension of infusions
[ Time Frame: Day 1 through Day 29 ]

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

Measured in days. 		Duration of hospitalization
[ Time Frame: Day 1 through Day 29 ]

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

 Duration of new mechanical ventilation
[ Time Frame: Day 1 through Day 29 ]
15. Duration of new oxygen use
[ Time Frame: Day 1 through Day 29 ]

 Duration of new oxygen use
[ Time Frame: Day 1 through Day 29 ]
16. Incidence of new mechanical ventilation
[ Time Frame: Day 1 through Day 29 ]

 Incidence of new mechanical ventilation
[ Time Frame: Day 1 through Day 29 ]
17. Incidence of new oxygen use
[ Time Frame: Day 1 through Day 29 ]

 Incidence of new oxygen use
[ Time Frame: Day 1 through Day 29 ]
18. Mean change in the ordinal scale from baseline
[ 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) 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. 		Mean change in the ordinal scale from baseline
[ 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) 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.
19. Number of oxygenation free days
[ Time Frame: Day 1 to Day 29 ]

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

 Number of ventilator free days
[ Time Frame: Day 1 to Day 29 ]
21. Subject clinical status using ordinal scale
[ 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) 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. 		Subject clinical status using ordinal scale
[ 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) 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.
22. Subject mortality
[ Time Frame: Day 1 through Day 29 ]

Date and cause of death (if applicable). 		Subject mortality
[ Time Frame: Day 1 through Day 29 ]

Date and cause of death (if applicable).
23. Time to an improvement of one category from admission 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; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. 		Time to an improvement of one category from admission 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; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
24. Time to discharge or to a National Early Warning Score (NEWS) of [ 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. 		Time to discharge or to a National Early Warning Score (NEWS) of [ 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.
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age: 99 Years 99 Years
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  2. Understands and agrees to comply with planned study procedures.
  3. Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol.
  4. Male or non-pregnant female adult >/=18 years of age at time of enrollment.
  5. 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.
  6. Illness of any duration, and at least one of the following:
    • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
    • Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR
    • Requiring mechanical ventilation and/or supplemental oxygen.
  7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

Exclusion Criteria:

  1. Alanine transaminase/aspartate transaminase (ALT/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)
  3. Pregnancy or breast feeding.
  4. Anticipated transfer to another hospital which is not a study site within 72 hours.
  5. Allergy to any study medication.

Inclusion Criteria:

  1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  2. Understands and agrees to comply with planned study procedures.
  3. Agrees to the collection of oropharyngeal (OP) swabs and venous blood per protocol.
  4. Male or non-pregnant female adult >/=18 years of age at time of enrollment.
  5. 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.
  6. Illness of any duration, and at least one of the following:
    • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
    • Clinical assessment (evidence of rales/crackles on exam) AND SpO2 </= 94% on room air, OR
    • Requiring mechanical ventilation and/or supplemental oxygen.
  7. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

Exclusion Criteria:

  1. Alanine transaminase/aspartate transaminase (ALT/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)
  3. Pregnancy or breast feeding.
  4. Anticipated 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		Andre Kalil
Telephone: 14025598650
Email: akalil@unmc.edu
Locations: United States, NebraskaUnited States, Nebraska
University of Nebraska Medical Center - Infectious Diseases
[Recruiting]
Omaha, Nebraska, United States, 68198-5400		University of Nebraska Medical Center - Infectious Diseases
[Recruiting]
Omaha, Nebraska, United States, 68198-5400
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services