search
Back to results

Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RDV
Placebo to Match RDV
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:

  • Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures

  • Either:

    • Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease)
    • Or aged ≥ 60 years
  • Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening
  • Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization
  • Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care)

Key Exclusion Criteria:

  • Participation in any other clinical trial of an experimental treatment and prevention for COVID-19
  • Prior hospitalization for COVID-19
  • Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine
  • Requiring oxygen supplementation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Arizona Liver Health
  • Arizona Clinical Trials
  • St Joseph Hospital Eureka
  • St. Joseph Heritage Healthcare
  • Elevated Health
  • Ruane Clinical Research Group
  • LA Universal Center, INC.
  • Mills Clinical Research
  • Kaiser Permanente Northern California
  • FOMAT Medical Research
  • UC Davis Health
  • Kaiser Permanente Northern California, 6600 Bruceville Road
  • Kaiser Permanente Northern California, 2025 Morse Ave
  • Kaiser Permanente Northern California, 1200 El Camino Real
  • Kaiser Permanente Northern California, 2425 Geary Blvd
  • UCSF Medical Center
  • Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850
  • Kaiser Permanente Northern California, 2500 Merced St
  • St. Joseph Heritage Healthcare
  • Premiere Medical Center of Burbank, Inc
  • Kaiser Permanente Northern California, 975 Sereno Drive
  • New Hope Research Development DBA HCD
  • Centura Health Porter Place
  • Nuvance Health
  • RecioMed Clinical Research Network
  • Midland Florida Clinical Research Center, LLC
  • Invesclinic
  • Lawnwood Regional Medical Center
  • Evolution Clinical Trials
  • Encore Medical Research
  • Advanced Pulmonary Research Institute
  • L&C Professional Medical Research Institute
  • Laguna Clinical Research Associates
  • CTMD Research, Inc
  • IMIC Inc
  • Luminous Clinical Research - South Florida Urgent Care
  • St. Josephs Comprehensive Research Institute
  • AIDS Research and Treatment Center of the Treasure Coast
  • Triple O Research Institute PA
  • Agile Clinical Research Trials
  • Mercer University School of Medicine
  • Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.
  • Metro Infectious Disease Consultants
  • NorthStar Medical Center
  • NorthShore University Healthsystem
  • Tulane University
  • Holy Cross Hospital, Inc.
  • University of Maryland Baltimore
  • Tufts Medical Center
  • South Shore Hospital
  • VA Boston Healthcare System
  • Be Well Medical Center
  • Onyx Research Institute
  • Memorial Hospital of Gulfport
  • Metro Infectious Disease Consultants
  • Quality Clinical Research Inc.
  • AB Clinical Trials
  • AXCES Research Group
  • New York Presbyterian Hospital
  • Northwell Health
  • Atrium Health Carolinas Medical Center
  • East Carolina University
  • Rosedale Infectious Diseases
  • Christ Hospital
  • Cherokee Nation WW Hastings Hospital
  • Providence St. Vincent Medical Center
  • Temple University
  • Avera Research Institute
  • University of Tennessee Health Science Center
  • Central Texas Clinical Research
  • UT Physicians
  • Baylor University Medical Center, 700 Scott and White Dr.
  • Baylor University Medical Center
  • UT Southwestern Medical Center
  • Care United Research, LLC
  • VIP Trials
  • University of Texas
  • The Crofoot Research Center, Inc
  • Baylor University Medical Center, 1901 North McArthur Blvd
  • Laguna Clinical Research Associates
  • Diagnostic Clinic of Longview - Center for Clinical Research
  • STAAMP Research
  • Sugar Lakes Family Practice
  • Baylor University Medical Center, 2201 MacArthur Dr., Suite 100
  • ClinPoint Trials
  • Intermountain Healthcare
  • Virginia Commonwealth University
  • Providence Regional Medical Center Everett
  • Sound Medical Research
  • Fred Hutchinson Cancer Research Center
  • Providence Medical Research Center
  • Wisconsin Corporation for Biomedical Research
  • Aalborg University Hospital
  • Aarhus University Hospital
  • Rigshospitalet
  • Hvidovre Hospital
  • Odense University Hospital
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Clinic
  • Hospital Universitario Infanta Leonor
  • Bradford Teaching Hospitals NHS Foundation Trust
  • University College Hospital
  • St Mary's Hospital
  • Newcastle Upon Tyne Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Remdesivir (RDV)

Placebo

Arm Description

Participants will receive a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.

Participants will receive IV placebo to match (PTM) RDV on Days 1 to 3.

Outcomes

Primary Outcome Measures

Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28
The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.

Secondary Outcome Measures

Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28
The composite outcome of COVID-19 related MAVs or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Percentage of Participants Who Died by Day 28
Percentage of Participants With COVID-19 Related Hospitalization at Day 28
COVID-19 related hospitalization is defined as at least 24 hours of acute care derived by COVID-19 related hospitalization reported by the site. The percentage of the outcome and the corresponding 95% confidence interval were from Kaplan-Meier estimate.
Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14
The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14
The composite outcome of COVID-19 related MAVs or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7
The time-weighted average change from baseline to study Day 7 (DAVG7) in SARS-CoV-2 viral load is defined as the time-weighted average between the first postbaseline value through the last available value up to Day 7 minus the baseline value in SARS-CoV-2 viral load (log10 copies/mL). DAVG7 is calculated using the trapezoidal rule and the area under the curve (AUC). For participants with data through days prior to Day 7, the time-weighted average change used data up to last available timepoint. If there was no postbaseline data, the participant was excluded from the analysis.
Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus)
The COVID-19-adapted FLU-PRO Plus is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). Time to alleviation of baseline COVID-19 symptoms is defined (in days) as: First Date of the two consecutive dates achieving alleviation - First dose Date + 1. If a participant had not achieved symptom alleviation at last FLU-PRO Plus assessment or early discontinuation of study, the participant was censored at last FLU-PRO Plus assessment date.
Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire
The worsening after alleviation of baseline COVID-19 symptoms is defined as for a participant who has achieved alleviation of baseline COVID-19 symptoms, if symptom scored as 2 or higher at baseline is scored as 2 or higher postbaseline after achieved alleviation, or symptoms scored as 1 at baseline are scored as 1 or higher postbaseline after achieved alleviation. The COVID-19-adapted FLU-PRO Plus was used. It is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild).
Percentage of Participants Who Required Oxygen Supplementation by Day 28

Full Information

First Posted
August 5, 2020
Last Updated
November 4, 2021
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04501952
Brief Title
Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
Official Title
A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
May 6, 2021 (Actual)
Study Completion Date
May 6, 2021 (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 objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.

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
584 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remdesivir (RDV)
Arm Type
Experimental
Arm Description
Participants will receive a single dose of intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive IV placebo to match (PTM) RDV on Days 1 to 3.
Intervention Type
Drug
Intervention Name(s)
RDV
Other Intervention Name(s)
GS-5734™, Veklury®
Intervention Description
Administered as an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo to Match RDV
Intervention Description
Administered as an intravenous infusion
Primary Outcome Measure Information:
Title
Percentage of Participants With Coronavirus Disease 2019 (COVID-19) Related Hospitalization (Defined as at Least 24 Hours of Acute Care) or All-Cause Death by Day 28
Description
The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame
Randomization up to Day 28
Title
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Description
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Time Frame
First dose date up to last dose date (maximum: 3 days) plus 30 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With COVID-19 Related Medical Visits Attended in Person by the Participant and a Health Care Professional (MAVs) or All-Cause Death by Day 28
Description
The composite outcome of COVID-19 related MAVs or all-cause death by Day 28 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame
Randomization up to Day 28
Title
Percentage of Participants Who Died by Day 28
Time Frame
Randomization up to Day 28
Title
Percentage of Participants With COVID-19 Related Hospitalization at Day 28
Description
COVID-19 related hospitalization is defined as at least 24 hours of acute care derived by COVID-19 related hospitalization reported by the site. The percentage of the outcome and the corresponding 95% confidence interval were from Kaplan-Meier estimate.
Time Frame
Randomization up to Day 28
Title
Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14
Description
The composite outcome of COVID-19 related hospitalization (defined as at least 24 hours of acute care) or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related hospitalization reported by the site. The first COVID-19 related hospitalization was used for the percentage of COVID-19 related hospitalization or all-cause death. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame
Randomization up to Day 14
Title
Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14
Description
The composite outcome of COVID-19 related MAVs or all-cause death by Day 14 was derived by combining the available all-cause death and COVID-19 related MAVs reported by the site. The percentage of the composite outcome was from the Kaplan-Meier estimate.
Time Frame
Randomization up to Day 14
Title
Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7
Description
The time-weighted average change from baseline to study Day 7 (DAVG7) in SARS-CoV-2 viral load is defined as the time-weighted average between the first postbaseline value through the last available value up to Day 7 minus the baseline value in SARS-CoV-2 viral load (log10 copies/mL). DAVG7 is calculated using the trapezoidal rule and the area under the curve (AUC). For participants with data through days prior to Day 7, the time-weighted average change used data up to last available timepoint. If there was no postbaseline data, the participant was excluded from the analysis.
Time Frame
Baseline up to Day 7
Title
Time to Alleviation (Mild or Absent) of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted Influenza Patient-Reported Outcome Plus Questionnaire (FLU-PRO Plus)
Description
The COVID-19-adapted FLU-PRO Plus is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild). Time to alleviation of baseline COVID-19 symptoms is defined (in days) as: First Date of the two consecutive dates achieving alleviation - First dose Date + 1. If a participant had not achieved symptom alleviation at last FLU-PRO Plus assessment or early discontinuation of study, the participant was censored at last FLU-PRO Plus assessment date.
Time Frame
First Dose Date up to Day 14
Title
Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire
Description
The worsening after alleviation of baseline COVID-19 symptoms is defined as for a participant who has achieved alleviation of baseline COVID-19 symptoms, if symptom scored as 2 or higher at baseline is scored as 2 or higher postbaseline after achieved alleviation, or symptoms scored as 1 at baseline are scored as 1 or higher postbaseline after achieved alleviation. The COVID-19-adapted FLU-PRO Plus was used. It is a questionnaire that assesses the severity of symptoms in participants with COVID-19 across six body systems: nose, throat, eyes, chest/respiratory, gastrointestinal, and body/systemic. Each domain scores range from 0 (symptom free) to 4 (very severe symptoms). A higher score indicates increased symptom severity. Alleviation is defined as symptom scores of 0 (absent) or 1 (mild).
Time Frame
First dose date up to Day 28
Title
Percentage of Participants Who Required Oxygen Supplementation by Day 28
Time Frame
Randomization up to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Willing and able to provide written informed consent, (individuals ≥ 18 years of age) or assent (individuals ≥ 12 and < 18 years of age) prior to performing study procedures. Individuals age ≥ 18 years may be enrolled with the consent of a legal representative where permitted according to local law and approved nationally and by the relevant institutional review board (IRB) or independent ethics committee (IEC). For individuals ≥ 12 and < 18 years of age, a parent or legal guardian must be willing and able to provide written informed consent prior to performing study procedures Either: Age ≥ 18 years (at all sites) or aged ≥ 12 and < 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant IRB or IEC with at least 1 pre-existing risk factor for progression to hospitalization (chronic lung disease, hypertension, cardiovascular or cerebrovascular disease, diabetes, obesity (body mass index ≥ 30), immunocompromised, chronic mild or moderate kidney disease, chronic liver disease, current cancer, or sickle cell disease) Or aged ≥ 60 years Severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 infection confirmed by molecular diagnosis (nucleic acid (polymerase chain reaction (PCR) or antigen testing) ≤ 4 days prior to screening Presence of ≥ 1 symptom(s) consistent with COVID-19 for ≤ 7 days prior to randomization Not currently requiring hospitalization (hospitalization defined as ≥ 24 hours of acute care) Key Exclusion Criteria: Participation in any other clinical trial of an experimental treatment and prevention for COVID-19 Prior hospitalization for COVID-19 Treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 or administration of any SARS-CoV-2 (or COVID-19) vaccine Requiring oxygen supplementation 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
Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Clinical Trials
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
St Joseph Hospital Eureka
City
Eureka
State/Province
California
ZIP/Postal Code
95501
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92385
Country
United States
Facility Name
Elevated Health
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Ruane Clinical Research Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
LA Universal Center, INC.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Mills Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Kaiser Permanente Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
FOMAT Medical Research
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Northern California, 6600 Bruceville Road
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente Northern California, 2025 Morse Ave
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Kaiser Permanente Northern California, 1200 El Camino Real
City
San Francisco
State/Province
California
ZIP/Postal Code
94080
Country
United States
Facility Name
Kaiser Permanente Northern California, 2425 Geary Blvd
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente Northern California, 2500 Merced St
City
San Leandro
State/Province
California
ZIP/Postal Code
94577
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Premiere Medical Center of Burbank, Inc
City
Toluca Lake
State/Province
California
ZIP/Postal Code
91602
Country
United States
Facility Name
Kaiser Permanente Northern California, 975 Sereno Drive
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
New Hope Research Development DBA HCD
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Centura Health Porter Place
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Nuvance Health
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
RecioMed Clinical Research Network
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Midland Florida Clinical Research Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Invesclinic
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Lawnwood Regional Medical Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Evolution Clinical Trials
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Encore Medical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33201
Country
United States
Facility Name
Advanced Pulmonary Research Institute
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
L&C Professional Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Laguna Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
CTMD Research, Inc
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33406
Country
United States
Facility Name
IMIC Inc
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Luminous Clinical Research - South Florida Urgent Care
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
St. Josephs Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research and Treatment Center of the Treasure Coast
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Triple O Research Institute PA
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Agile Clinical Research Trials
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Mercer University School of Medicine
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527
Country
United States
Facility Name
Metro Infectious Disease Consultants
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527
Country
United States
Facility Name
NorthStar Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
NorthShore University Healthsystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Holy Cross Hospital, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
South Shore Hospital
City
South Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
VA Boston Healthcare System
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Onyx Research Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Memorial Hospital of Gulfport
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
Metro Infectious Disease Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Quality Clinical Research Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
AXCES Research Group
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
New York Presbyterian Hospital
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Atrium Health Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Rosedale Infectious Diseases
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cherokee Nation WW Hastings Hospital
City
Tahlequah
State/Province
Oklahoma
ZIP/Postal Code
74464
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
92775
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
UT Physicians
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Baylor University Medical Center, 700 Scott and White Dr.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Care United Research, LLC
City
Forney
State/Province
Texas
ZIP/Postal Code
75126
Country
United States
Facility Name
VIP Trials
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Crofoot Research Center, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Baylor University Medical Center, 1901 North McArthur Blvd
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Laguna Clinical Research Associates
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Diagnostic Clinic of Longview - Center for Clinical Research
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
STAAMP Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sugar Lakes Family Practice
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Baylor University Medical Center, 2201 MacArthur Dr., Suite 100
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Facility Name
Intermountain Healthcare
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Sound Medical Research
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Providence Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Wisconsin Corporation for Biomedical Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
DK9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK5000
Country
Denmark
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Bradford Teaching Hospitals NHS Foundation Trust
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 6BN
Country
United Kingdom
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
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.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-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.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
PubMed Identifier
34937145
Citation
Gottlieb RL, Vaca CE, Paredes R, Mera J, Webb BJ, Perez G, Oguchi G, Ryan P, Nielsen BU, Brown M, Hidalgo A, Sachdeva Y, Mittal S, Osiyemi O, Skarbinski J, Juneja K, Hyland RH, Osinusi A, Chen S, Camus G, Abdelghany M, Davies S, Behenna-Renton N, Duff F, Marty FM, Katz MJ, Ginde AA, Brown SM, Schiffer JT, Hill JA; GS-US-540-9012 (PINETREE) Investigators. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022 Jan 27;386(4):305-315. doi: 10.1056/NEJMoa2116846. Epub 2021 Dec 22.
Results Reference
derived

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting

We'll reach out to this number within 24 hrs