Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04745351
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Remdesivir Drug: RDV Placebo Drug: Standard of Care Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Remdesivir (RDV)
Participants will receive continued Standard of Care (SOC) therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg from Day 2 up to Day 5.
Drug: Remdesivir
Administered as Intravenous (IV) infusion once daily
Other Names:
  • GS-5734™
  • Veklury®

Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection

Placebo Comparator: Placebo
Participants will receive continued SOC therapy together with RDV placebo on Day 1 followed by RDV placebo from Day 2 up to Day 5.
Drug: RDV Placebo
Administered as IV saline once daily

Drug: Standard of Care
Standard of Care Treatment for COVID-19 Infection




Primary Outcome Measures :
  1. Composite of All-Cause Mortality or Invasive Mechanical Ventilation (IMV) Through Day 29 [ Time Frame: First dose date up to Day 29 ]
    The composite of all-cause mortality or IMV is the combined endpoint of the percentage of participants who die or initiate on IMV through Day 29.


Secondary Outcome Measures :
  1. All-Cause Mortality Through Day 29 [ Time Frame: First dose date up to Day 29 ]
    The percentage of participants who die through Day 29 will be assessed.

  2. Invasive Mechanical Ventilation Through Day 29 [ Time Frame: First dose date up to Day 29 ]
    The percentage of participants who initiate on IMV through Day 29 will be assessed.

  3. Time to Recovery [ Time Frame: First dose date up to Day 29 ]
    Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant satisfies one of the following three categories from the 8-point ordinal scale: 1) Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration).

  4. Clinical Status Assessed by an 8-Point Ordinal Scale on Day 15 [ Time Frame: Day 15 ]
    Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day will be recorded. The Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); and 8. Death. Higher scores indicate worst clinical status.

  5. Clinical Status Assessed by an 8-Point Ordinal Scale on Day 29 [ Time Frame: Day 29 ]
    Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day will be recorded. The Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; and 8. Death. Higher scores indicate worst clinical status.

  6. Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Randomization) Through Day 29 [ Time Frame: First dose date up to Day 29 ]
  7. Recovery Through Day 29 [ Time Frame: First dose date up to Day 29 ]
    Recovery is defined as the participant satisfying one of the following three categories from the 8-point ordinal scale: 1) Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration).

  8. Percentage of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: First dose date up to last dose date (Maximum: Day 5) plus 30 days ]
  9. Percentage of Participants who Permanently Discontinue Investigational Drug due to Adverse Events (AEs) [ Time Frame: First dose date up to last dose date (Maximum: Day 5) plus 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by Polymerase Chain Reaction (PCR) or other commercially available or public health assay (eg, Nucleic Acid Amplification Test [NAAT] and antigen tests) in any respiratory specimen
  • Hospitalized for COVID-19
  • Weighing at least 40 kilograms (kg)
  • Oxygen (O2) saturation ≤ 94% on room air or requiring O2 supplement or Radiographic evidence of pulmonary infiltrates for COVID-19
  • Severely reduced kidney function (estimated Glomerular Filtration Rate [eGFR] < 30 milliliters per minute per 1.73 square meters [mL/min/1.73 m^2]), including people with ESKD requiring chronic dialysis
  • The interval between COVID-19 symptoms onset and randomization is no more than 10 days

Key Exclusion Criteria:

  • Received any investigational drug, RDV, or other antiviral treatment for COVID-19
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal
  • Invasive mechanical ventilation, noninvasive mechanical ventilation, ECMO, or RRT for acute kidney injury (AKI)
  • Positive serum pregnancy test at screening for women of childbearing potential or currently breastfeeding
  • Known hypersensitivity to the study drug, metabolites, or formulation sulfobutylether-beta-cyclodextrin (SBECD)

Note: Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745351


Contacts
Layout table for location contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04745351    
Other Study ID Numbers: GS-US-540-5912
2020-005416-22 ( EudraCT Number )
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No