Study 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 to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
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
2 other identifiers
interventional
584
4 countries
104
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Sep 2020
104 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedStudy Start
First participant enrolled
September 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2021
CompletedResults Posted
Study results publicly available
November 16, 2021
CompletedNovember 16, 2021
November 1, 2021
8 months
August 5, 2020
November 4, 2021
November 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Randomization up to Day 28
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.
First dose date up to last dose date (maximum: 3 days) plus 30 days
Secondary Outcomes (9)
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
Randomization up to Day 28
Percentage of Participants Who Died by Day 28
Randomization up to Day 28
Percentage of Participants With COVID-19 Related Hospitalization at Day 28
Randomization up to Day 28
Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14
Randomization up to Day 14
Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14
Randomization up to Day 14
- +4 more secondary outcomes
Study Arms (2)
Remdesivir (RDV)
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants will receive IV placebo to match (PTM) RDV on Days 1 to 3.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (104)
Arizona Liver Health
Chandler, Arizona, 85224, United States
Arizona Clinical Trials
Tucson, Arizona, 85712, United States
St Joseph Hospital Eureka
Eureka, California, 95501, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92385, United States
Elevated Health
Huntington Beach, California, 92648, United States
Ruane Clinical Research Group
Los Angeles, California, 90036, United States
LA Universal Center, INC.
Los Angeles, California, 90057, United States
Mills Clinical Research
Los Angeles, California, 90069, United States
Kaiser Permanente Northern California
Oakland, California, 94611, United States
FOMAT Medical Research
Oxnard, California, 93030, United States
UC Davis Health
Sacramento, California, 95817, United States
Kaiser Permanente Northern California, 6600 Bruceville Road
Sacramento, California, 95823, United States
Kaiser Permanente Northern California, 2025 Morse Ave
Sacramento, California, 95825, United States
Kaiser Permanente Northern California, 1200 El Camino Real
San Francisco, California, 94080, United States
Kaiser Permanente Northern California, 2425 Geary Blvd
San Francisco, California, 94115, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850
San Jose, California, 95119, United States
Kaiser Permanente Northern California, 2500 Merced St
San Leandro, California, 94577, United States
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403, United States
Premiere Medical Center of Burbank, Inc
Toluca Lake, California, 91602, United States
Kaiser Permanente Northern California, 975 Sereno Drive
Vallejo, California, 94589, United States
New Hope Research Development DBA HCD
Whittier, California, 90603, United States
Centura Health Porter Place
Denver, Colorado, 80210, United States
Nuvance Health
Danbury, Connecticut, 06810, United States
RecioMed Clinical Research Network
Boynton Beach, Florida, 33472, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720, United States
Invesclinic
Fort Lauderdale, Florida, 33308, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34982, United States
Evolution Clinical Trials
Hialeah Gardens, Florida, 33016, United States
Encore Medical Research
Hollywood, Florida, 33201, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470, United States
L&C Professional Medical Research Institute
Miami, Florida, 33144, United States
Laguna Clinical Research Associates
Miami, Florida, 33144, United States
CTMD Research, Inc
Palm Springs, Florida, 33406, United States
IMIC Inc
Palmetto Bay, Florida, 33157, United States
Luminous Clinical Research - South Florida Urgent Care
Pembroke Pines, Florida, 33029, United States
St. Josephs Comprehensive Research Institute
Tampa, Florida, 33614, United States
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, 32960, United States
Triple O Research Institute PA
West Palm Beach, Florida, 33401, United States
Agile Clinical Research Trials
Atlanta, Georgia, 30328, United States
Mercer University School of Medicine
Macon, Georgia, 31210, United States
Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.
Burr Ridge, Illinois, 60527, United States
Metro Infectious Disease Consultants
Burr Ridge, Illinois, 60527, United States
NorthStar Medical Center
Chicago, Illinois, 60657, United States
NorthShore University Healthsystem
Evanston, Illinois, 60201, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Holy Cross Hospital, Inc.
Baltimore, Maryland, 21201, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
VA Boston Healthcare System
West Roxbury, Massachusetts, 02132, United States
Be Well Medical Center
Berkley, Michigan, 48072, United States
Onyx Research Institute
Flint, Michigan, 48532, United States
Memorial Hospital of Gulfport
Gulfport, Mississippi, 39501, United States
Metro Infectious Disease Consultants
Kansas City, Missouri, 64132, United States
Quality Clinical Research Inc.
Omaha, Nebraska, 68114, United States
AB Clinical Trials
Las Vegas, Nevada, 89119, United States
AXCES Research Group
Santa Fe, New Mexico, 87505, United States
New York Presbyterian Hospital
Flushing, New York, 11355, United States
Northwell Health
New Hyde Park, New York, 11040, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28209, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
Cherokee Nation WW Hastings Hospital
Tahlequah, Oklahoma, 74464, United States
Providence St. Vincent Medical Center
Portland, Oregon, 92775, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Avera Research Institute
Sioux Falls, South Dakota, 57108, United States
University of Tennessee Health Science Center
Knoxville, Tennessee, 37920, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
UT Physicians
Bellaire, Texas, 77401, United States
Baylor University Medical Center, 700 Scott and White Dr.
College Station, Texas, 77845, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Care United Research, LLC
Forney, Texas, 75126, United States
VIP Trials
Harlingen, Texas, 78550, United States
University of Texas
Houston, Texas, 77030, United States
The Crofoot Research Center, Inc
Houston, Texas, 77098, United States
Baylor University Medical Center, 1901 North McArthur Blvd
Irving, Texas, 75061, United States
Laguna Clinical Research Associates
Laredo, Texas, 78041, United States
Diagnostic Clinic of Longview - Center for Clinical Research
Longview, Texas, 75605, United States
STAAMP Research
San Antonio, Texas, 78229, United States
Sugar Lakes Family Practice
Sugar Land, Texas, 77479, United States
Baylor University Medical Center, 2201 MacArthur Dr., Suite 100
Waco, Texas, 76708, United States
ClinPoint Trials
Waxahachie, Texas, 75165, United States
Intermountain Healthcare
Murray, Utah, 84107, United States
Virginia Commonwealth University
Richmond, Virginia, 23249, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Sound Medical Research
Port Orchard, Washington, 98366, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Providence Medical Research Center
Spokane, Washington, 99204, United States
Wisconsin Corporation for Biomedical Research
Milwaukee, Wisconsin, 53295, United States
Aalborg University Hospital
Aalborg, DK9000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Hvidovre Hospital
Hvidovre, 2650, Denmark
Odense University Hospital
Odense, DK5000, Denmark
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Clinic
Barcelona, 08036, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ, United Kingdom
University College Hospital
London, NW1 6BN, United Kingdom
St Mary's Hospital
London, W2 1NY, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (4)
Rodriguez L, Lee HW, Li J, Martin R, Han D, Xu S, Moshiri J, Peinovich N, Camus G, Perry JK, Hyland RH, Porter DP, Abdelghany M, Gotte M, Hedskog C. SARS-CoV-2 resistance analyses from the Phase 3 PINETREE study of remdesivir treatment in nonhospitalized participants. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0123824. doi: 10.1128/aac.01238-24. Epub 2024 Dec 19.
PMID: 39699245DERIVEDBrown SM, Katz MJ, Ginde AA, Juneja K, Ramchandani M, Schiffer JT, Vaca C, Gottlieb RL, Tian Y, Elboudwarej E, Hill JA, Gilson R, Rodriguez L, Hedskog C, Chen S, Montezuma-Rusca JM, Osinusi A, Paredes R. Consistent Effects of Early Remdesivir on Symptoms and Disease Progression Across At-Risk Outpatient Subgroups: Treatment Effect Heterogeneity in PINETREE Study. Infect Dis Ther. 2023 Apr;12(4):1189-1203. doi: 10.1007/s40121-023-00789-y. Epub 2023 Apr 19.
PMID: 37074613DERIVEDGrundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
PMID: 36695483DERIVEDGottlieb 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.
PMID: 34937145DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 6, 2020
Study Start
September 18, 2020
Primary Completion
May 6, 2021
Study Completion
May 6, 2021
Last Updated
November 16, 2021
Results First Posted
November 16, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
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.