History of Changes for Study: NCT04745351

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)

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Study Record Versions

Version	Submitted Date	Changes
1	February 8, 2021	None (earliest Version on record)
2	March 5, 2021	Recruitment Status, Study Status and Contacts/Locations
3	March 19, 2021	Contacts/Locations and Study Status
4	April 16, 2021	Study Status, Contacts/Locations and Study Identification
5	April 30, 2021	Contacts/Locations and Study Status
6	May 20, 2021	Study Status and Contacts/Locations
7	June 10, 2021	Contacts/Locations and Study Status
8	July 1, 2021	Study Status and Contacts/Locations
9	July 22, 2021	Contacts/Locations and Study Status
10	August 11, 2021	Study Status and Contacts/Locations
11	August 20, 2021	Contacts/Locations and Study Status
12	September 20, 2021	Contacts/Locations, Study Status, References and Eligibility
13	October 18, 2021	Contacts/Locations, Study Status and Eligibility
14	November 12, 2021	Study Status and Contacts/Locations
15	December 1, 2021	Study Status
16	December 21, 2021	Contacts/Locations and Study Status
17	January 12, 2022	Study Status
18	February 1, 2022	Study Status, Contacts/Locations and Study Identification
19	February 24, 2022	Contacts/Locations and Study Status
20	March 15, 2022	Contacts/Locations and Study Status
21	March 31, 2022	Recruitment Status, Contacts/Locations and Study Status
22	May 10, 2022	Study Status and Study Design
23	June 1, 2022	Recruitment Status, IPDSharing and Study Status
24	April 18, 2023	Outcome Measures, Study Status, Document Section, Results, Eligibility and Arms and Interventions

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	GS-US-540-5912
Brief Title:	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:	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
Secondary IDs:	2020-005416-22 [EudraCT Number]

Study Status


Record Verification:	February 2021
Overall Status:	Not yet recruiting
Study Start:	February 2021
Primary Completion:	July 2021 [Anticipated]
Study Completion:	August 2021 [Anticipated]

First Submitted:	February 8, 2021
First Submitted that Met QC Criteria:	February 8, 2021
First Posted:	February 9, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	February 8, 2021
Last Update Posted:	February 9, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Gilead Sciences
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


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:

Conditions


Conditions:	COVID-19
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	1116 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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

Outcome Measures


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 ]

Eligibility


Minimum Age:	12 Years
Maximum Age:
Sex:	All
Gender Based:
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

Contacts/Locations


Central Contact Person:	Gilead Clinical Study Information Center Telephone: 1-833-445-3230 (GILEAD-0) Email: GileadClinicalTrials@gilead.com
Study Officials:	Gilead Study Director Study Director Gilead Sciences
Locations:

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: