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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) (REDPINE)

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Remdesivir
RDV Placebo
Standard of Care
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Have either:

    • a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis
    • b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care
  • 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

Sites / Locations

  • St. Vincent's Health System
  • UAB Hospital
  • Pulmonary Associates of Mobile, P.C.
  • St. Joseph Hospital Eureka
  • Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave
  • Hoag Memorial Hospital Presbyterian
  • Sutter Medical Center Sacramento
  • Torrance Memorial Medical Center
  • MedStar Health Research Institute
  • George Washington Medical Faculty Associates
  • North Florida/ South Georgia Veterans Health System
  • Mayo Clinic Florida
  • Genesis Clinical Research
  • Northwestern Medicine Central DuPage Hospital
  • Baptist Health Lexington
  • Tulane Medical Center, 2000 Canal St.
  • Tulane Medical Center
  • Wake Forest University Health Sciences
  • Holy Cross Hospital, 19801 Observation Dr
  • Holy Cross Hospital
  • Massachusetts General Hospital
  • Newton-Wellesley Hospital
  • St. Clair Nephrology Research
  • G.V. (Sonny) Montgomery VAMC
  • Mayo Clinic Hospital
  • Saint Michael's Medical Center
  • University of New Mexico Hospital
  • Jacobi Medical Center
  • New York - Presbyterian Hospital/Weill Cornell Medical Center
  • Stony Brook University Hospital
  • PMG Infectious Disease Consultants (administrative)
  • Temple University Hospital
  • Medical University of South Carolina
  • Houston Methodist Hospital
  • Memorial Hermann Hospital at TMC
  • VCU Health Medical Center
  • Providence Regional Medical Center Everett
  • Swedish Medical Center
  • Providence Health Care
  • Providence Health Care, 5633 N Lidgerwood
  • MultiCare Good Samaritan Hospital
  • Hospital e Maternidade Celso Pierro/ Sociedade Campineira de Educacao e Instrucao/ PUC Campinas
  • Hospital Nossa Senhora das Gracas
  • Hospital Alemao Oswaldo Cruz
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • Centro Hospitalar Cova da Beira EPE
  • Hospital Nélio Mendonça,
  • Centro Hospitalar Lisboa Ocidental
  • Centro Hospitalar do Porto - Hospital de Santo Antonio
  • Centro Hospitalar de Vila Nova de Gaia
  • George Regional Hospital
  • Mediclinic Vergelegen
  • Hospital Universitario Germans Trias I Pujol
  • Hospital del Mar
  • Hospital Universitari de Bellvitge
  • Hospital Clinic de Barcelona
  • Hospital General Universitario de Elche
  • Hospital Universitario 12 de Octubre
  • Complejo Asistencial Universitario de Salamanca - H. Clinico
  • Hospital General Universitario de Valencia
  • Barts Health NHS Trust, The Royal London Hospital
  • Kings College Hospital
  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Remdesivir (RDV)

Placebo

Arm Description

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.

Participants will receive continued SOC therapy together with RDV matching placebo on Day 1 followed by RDV matching placebo from Day 2 up to Day 5.

Outcomes

Primary Outcome Measures

Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.

Secondary Outcome Measures

All-cause Mortality Through Day 29
The reported percentage was from the Kaplan-Meier estimate.
Percentage of Participants With Initiation of IMV Through Day 29
The reported percentage was the cumulative-incidence estimate.
Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.
Time to Recovery Independent of Further Worsening by Day 29
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point 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 IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point 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 IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.
Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.
Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.

Full Information

First Posted
February 8, 2021
Last Updated
April 18, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04745351
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)
Acronym
REDPINE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remdesivir (RDV)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive continued SOC therapy together with RDV matching placebo on Day 1 followed by RDV matching placebo from Day 2 up to Day 5.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
GS-5734™, Veklury®
Intervention Description
Administered as Intravenous (IV) infusion once daily
Intervention Type
Drug
Intervention Name(s)
RDV Placebo
Intervention Description
Administered as IV saline once daily
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Standard of Care Treatment for COVID-19 Infection
Primary Outcome Measure Information:
Title
Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
Description
This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.
Time Frame
First dose date up to Day 29
Secondary Outcome Measure Information:
Title
All-cause Mortality Through Day 29
Description
The reported percentage was from the Kaplan-Meier estimate.
Time Frame
First dose date up to Day 29
Title
Percentage of Participants With Initiation of IMV Through Day 29
Description
The reported percentage was the cumulative-incidence estimate.
Time Frame
First dose date up to Day 29
Title
Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
Description
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.
Time Frame
First dose date up to Day 29
Title
Time to Recovery Independent of Further Worsening by Day 29
Description
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.
Time Frame
First dose date up to Day 29
Title
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Description
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point 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 IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Time Frame
Day 15
Title
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Description
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point 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 IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Time Frame
Day 29
Title
Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
Description
The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.
Time Frame
First dose date up to Day 29
Title
Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
Description
Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Time Frame
First dose date up to Day 29
Title
Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
Description
Recovery is defined as the first day on which the participant with a baseline score >= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Time Frame
First dose date up to Day 29
Title
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Description
An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.
Time Frame
First dose date up to last dose date (Maximum: 5 days) plus 30 days
Title
Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.
Time Frame
First dose date up to last dose date (Maximum: 5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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 Have either: a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2), including people with end-stage kidney disease (ESKD) requiring chronic dialysis b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum creatinine (SCr) within a 48-hour period that is sustained (ie, requires confirmatory SCr) for ≥ 6 hours despite supportive care 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, extracorporeal membrane oxygenation (ECMO), or renal replacement therapy (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
St. Vincent's Health System
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pulmonary Associates of Mobile, P.C.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
St. Joseph Hospital Eureka
City
Eureka
State/Province
California
ZIP/Postal Code
95501
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian, 16200 Sand Canyon Ave
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
MedStar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
George Washington Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
North Florida/ South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Genesis Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Northwestern Medicine Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Tulane Medical Center, 2000 Canal St.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Holy Cross Hospital, 19801 Observation Dr
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20876
Country
United States
Facility Name
Holy Cross Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
St. Clair Nephrology Research
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
G.V. (Sonny) Montgomery VAMC
City
Jackson
State/Province
Michigan
ZIP/Postal Code
39216
Country
United States
Facility Name
Mayo Clinic Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York - Presbyterian Hospital/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11716
Country
United States
Facility Name
PMG Infectious Disease Consultants (administrative)
City
Portland
State/Province
Oregon
ZIP/Postal Code
92775
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
92037
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Hospital at TMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VCU Health Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Providence Health Care
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Providence Health Care, 5633 N Lidgerwood
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
MultiCare Good Samaritan Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital e Maternidade Celso Pierro/ Sociedade Campineira de Educacao e Instrucao/ PUC Campinas
City
Campinas
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Hospital Nossa Senhora das Gracas
City
Curitiba
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
City
São José do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Centro Hospitalar Cova da Beira EPE
City
Covilhã
ZIP/Postal Code
6200-251
Country
Portugal
Facility Name
Hospital Nélio Mendonça,
City
Funchal
ZIP/Postal Code
9000-514
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Ocidental
City
Lisbon
ZIP/Postal Code
1449-005
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo Antonio
City
Odivelas
ZIP/Postal Code
2620-144
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
George Regional Hospital
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Mediclinic Vergelegen
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Hospital Universitario Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital General Universitario de Elche
City
Elche
ZIP/Postal Code
3203
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca - H. Clinico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Barts Health NHS Trust, The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gileadclinicaltrials.com/transparency-policy/
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-540-5912
Description
Gilead Clinical Trials Website

Learn more about this trial

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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