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 : Recruiting
First Posted : February 9, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE February 8, 2021
First Posted Date  ICMJE February 9, 2021
Last Update Posted Date March 23, 2021
Estimated Study Start Date  ICMJE March 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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 ]
  • 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).
  • Percentage of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: First dose date up to last dose date (Maximum: Day 5) plus 30 days ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Remdesivir
    Administered as Intravenous (IV) infusion once daily
    Other Names:
    • GS-5734™
    • Veklury®
  • Drug: RDV Placebo
    Administered as IV saline once daily
  • Drug: Standard of Care
    Standard of Care Treatment for COVID-19 Infection
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Remdesivir
    • Drug: Standard of Care
  • 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.
    Interventions:
    • Drug: RDV Placebo
    • Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
1116
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04745351
Other Study ID Numbers  ICMJE GS-US-540-5912
2020-005416-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP