COVID-19Phase 3NCT04501952

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 study testing RDV in people with COVID-19, run by Gilead Sciences at 104 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: COVID-19
What is being tested?: RDV
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 584 participants
Where: 104 sitesin 4 countries
Study dates: 18 Sep 2020to 6 May 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

104 sites in 4 countries.

Country

City, postcode or hospital

104 sites in 4 countries

United States92 sites

Agile Clinical Research Trials
Atlanta, Georgia, 30328
Central Texas Clinical Research
Austin, Texas, 78705
Holy Cross Hospital, Inc.
Baltimore, Maryland, 21201
University of Maryland Baltimore
Baltimore, Maryland, 21201
UT Physicians
Bellaire, Texas, 77401
Be Well Medical Center
Berkley, Michigan, 48072
Tufts Medical Center
Boston, Massachusetts, 02111
RecioMed Clinical Research Network
Boynton Beach, Florida, 33472
Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.
Burr Ridge, Illinois, 60527
Metro Infectious Disease Consultants
Burr Ridge, Illinois, 60527
Arizona Liver Health
Chandler, Arizona, 85224
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28209
NorthStar Medical Center
Chicago, Illinois, 60657
Christ Hospital
Cincinnati, Ohio, 45219
Baylor University Medical Center, 700 Scott and White Dr.
College Station, Texas, 77845
Baylor University Medical Center
Dallas, Texas, 75246
UT Southwestern Medical Center
Dallas, Texas, 75390
Nuvance Health
Danbury, Connecticut, 06810
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
Centura Health Porter Place
Denver, Colorado, 80210
St Joseph Hospital Eureka
Eureka, California, 95501
NorthShore University Healthsystem
Evanston, Illinois, 60201
Providence Regional Medical Center Everett
Everett, Washington, 98201
Onyx Research Institute
Flint, Michigan, 48532
New York Presbyterian Hospital
Flushing, New York, 11355
Care United Research, LLC
Forney, Texas, 75126
Invesclinic
Fort Lauderdale, Florida, 33308
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34982
St. Joseph Heritage Healthcare
Fullerton, California, 92385
East Carolina University
Greenville, North Carolina, 27858
Memorial Hospital of Gulfport
Gulfport, Mississippi, 39501
VIP Trials
Harlingen, Texas, 78550
Evolution Clinical Trials
Hialeah Gardens, Florida, 33016
Encore Medical Research
Hollywood, Florida, 33201
University of Texas
Houston, Texas, 77030
The Crofoot Research Center, Inc
Houston, Texas, 77098
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078
Elevated Health
Huntington Beach, California, 92648
Baylor University Medical Center, 1901 North McArthur Blvd
Irving, Texas, 75061
Metro Infectious Disease Consultants
Kansas City, Missouri, 64132
University of Tennessee Health Science Center
Knoxville, Tennessee, 37920
Laguna Clinical Research Associates
Laredo, Texas, 78041
AB Clinical Trials
Las Vegas, Nevada, 89119
Diagnostic Clinic of Longview - Center for Clinical Research
Longview, Texas, 75605
Ruane Clinical Research Group
Los Angeles, California, 90036
LA Universal Center, INC.
Los Angeles, California, 90057
Mills Clinical Research
Los Angeles, California, 90069
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470
Mercer University School of Medicine
Macon, Georgia, 31210
L&C Professional Medical Research Institute
Miami, Florida, 33144
Laguna Clinical Research Associates
Miami, Florida, 33144
Wisconsin Corporation for Biomedical Research
Milwaukee, Wisconsin, 53295
Intermountain Healthcare
Murray, Utah, 84107
Northwell Health
New Hyde Park, New York, 11040
Tulane University
New Orleans, Louisiana, 70112
Kaiser Permanente Northern California
Oakland, California, 94611
Quality Clinical Research Inc.
Omaha, Nebraska, 68114
FOMAT Medical Research
Oxnard, California, 93030
CTMD Research, Inc
Palm Springs, Florida, 33406
IMIC Inc
Palmetto Bay, Florida, 33157
Luminous Clinical Research - South Florida Urgent Care
Pembroke Pines, Florida, 33029
Temple University
Philadelphia, Pennsylvania, 19140
Sound Medical Research
Port Orchard, Washington, 98366
Providence St. Vincent Medical Center
Portland, Oregon, 92775
Virginia Commonwealth University
Richmond, Virginia, 23249
UC Davis Health
Sacramento, California, 95817
Kaiser Permanente Northern California, 6600 Bruceville Road
Sacramento, California, 95823
Kaiser Permanente Northern California, 2025 Morse Ave
Sacramento, California, 95825
STAAMP Research
San Antonio, Texas, 78229
Kaiser Permanente Northern California, 1200 El Camino Real
San Francisco, California, 94080
Kaiser Permanente Northern California, 2425 Geary Blvd
San Francisco, California, 94115
UCSF Medical Center
San Francisco, California, 94143
Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850
San Jose, California, 95119
Kaiser Permanente Northern California, 2500 Merced St
San Leandro, California, 94577
AXCES Research Group
Santa Fe, New Mexico, 87505
St. Joseph Heritage Healthcare
Santa Rosa, California, 95403
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Avera Research Institute
Sioux Falls, South Dakota, 57108
South Shore Hospital
South Weymouth, Massachusetts, 02190
Providence Medical Research Center
Spokane, Washington, 99204
Sugar Lakes Family Practice
Sugar Land, Texas, 77479
Cherokee Nation WW Hastings Hospital
Tahlequah, Oklahoma, 74464
St. Josephs Comprehensive Research Institute
Tampa, Florida, 33614
Premiere Medical Center of Burbank, Inc
Toluca Lake, California, 91602
Arizona Clinical Trials
Tucson, Arizona, 85712
Kaiser Permanente Northern California, 975 Sereno Drive
Vallejo, California, 94589
AIDS Research and Treatment Center of the Treasure Coast
Vero Beach, Florida, 32960
Baylor University Medical Center, 2201 MacArthur Dr., Suite 100
Waco, Texas, 76708
ClinPoint Trials
Waxahachie, Texas, 75165
Triple O Research Institute PA
West Palm Beach, Florida, 33401
VA Boston Healthcare System
West Roxbury, Massachusetts, 02132
New Hope Research Development DBA HCD
Whittier, California, 90603

Other trials in United States

Denmark5 sites

Aalborg University Hospital
Aalborg, DK9000
Aarhus University Hospital
Aarhus N, 8200
Rigshospitalet
Copenhagen, 2100
Hvidovre Hospital
Hvidovre, 2650
Odense University Hospital
Odense, DK5000

Other trials in Denmark

United Kingdom4 sites

Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
University College Hospital
London, NW1 6BN
St Mary's Hospital
London, W2 1NY
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Spain3 sites

Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Hospital Clinic
Barcelona, 08036
Hospital Universitario Infanta Leonor
Madrid, 28031

Other trials in Spain

About this study

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

Conditions: COVID-19
Being tested: RDV, Placebo to Match RDV
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RDVDrug
Also called GS-5734™, Veklury®
Administered as an intravenous infusion
Placebo to Match RDVDrug
Administered as an intravenous infusion

Study groups in NCT04501952
Study group	Role	What they receive
Remdesivir (RDV)	Experimental	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. Receives: Drug: RDV
Placebo	Placebo comparator	Participants will receive IV placebo to match (PTM) RDV on Days 1 to 3. Receives: Drug: Placebo to Match RDV

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: Randomization up to Day 28
Percentage of Participants Who Died by Day 28
Measured: Randomization up to 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.
Measured: Randomization up to Day 28
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.
Measured: Randomization up to Day 14
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.
Measured: Randomization up to Day 14
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.
Measured: Baseline up to Day 7
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.
Measured: First Dose Date up to Day 14
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).
Measured: First dose date up to Day 28
Percentage of Participants Who Required Oxygen Supplementation by Day 28
Measured: Randomization up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 20206 May 2021

First posted6 Aug 2020
Study start18 Sep 2020
Primary completion6 May 2021
Study completion6 May 2021

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 584 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04501952
Sponsor's protocol ID: GS-US-540-9012
Other IDs: 2020-003510-12
Status last verified: Nov 2021
First submitted: 5 Aug 2020
Last updated: 16 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.
Expanded access: Available

Publications

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.
PubMed 39699245
Brown 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.
PubMed 37074613
Grundeis 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.
PubMed 36695483
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.
PubMed 34937145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04501952
Acronym / sponsor ID: GS-US-540-9012
Conditions: COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 584 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 18 Sep 2020 (actual)
Primary completion: 6 May 2021 (actual)
Study completion: 6 May 2021 (actual)
First posted: 6 Aug 2020 (actual)
Results: Posted 16 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Remdesivir (RDV)	Experimental	Drug: RDVParticipants 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 comparator	Drug: Placebo to Match RDVParticipants will receive IV placebo to match (PTM) RDV on Days 1 to 3.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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:
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 (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RDVAlso: GS-5734™, Veklury®Administered as an intravenous infusion	Drug	Remdesivir (RDV)
Placebo to Match RDVAdministered as an intravenous infusion	Drug	Placebo

Primary outcome

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
Time frame: Randomization up to 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)
Time frame: First dose date up to last dose date (maximum: 3 days) plus 30 days
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.

9 secondary outcomes

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
Time frame: Randomization up to Day 28
Percentage of Participants Who Died by Day 28
Time frame: Randomization up to Day 28
Percentage of Participants With COVID-19 Related Hospitalization at Day 28
Time frame: Randomization up to Day 28
Percentage of Participants With COVID-19 Related Hospitalization or All-Cause Death by Day 14
Time frame: Randomization up to Day 14
Percentage of Participants With COVID-19 Related MAVs or All-Cause Death by Day 14
Time frame: Randomization up to Day 14
Time-Weighted Average Change in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load From Baseline to Day 7
Time frame: Baseline up to Day 7
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)
Time frame: First Dose Date up to Day 14
Percentage of Participants With Worsening After Alleviation of Baseline COVID-19 Symptoms as Reported on the COVID-19-adapted FLU-PRO Plus Questionnaire
Time frame: First dose date up to Day 28
Percentage of Participants Who Required Oxygen Supplementation by Day 28
Time frame: Randomization up to Day 28

Results and safety

Results posted to the registry on 16 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remdesivir (RDV)	292	266
Placebo	292	272

Primary outcome: 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

Time frame: Randomization up to Day 28. Number. Unit: percentage of participants

Measure	Remdesivir n = 279	Placebo n = 283
Value	0.7	5.4

Remdesivir vs Placebo: Hazard Ratio (HR): 0.134 (95% CI 0.031 to 0.586), p = 0.0076, Regression, Cox

Population analysed: Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.

Primary outcome: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

Time frame: First dose date up to last dose date (maximum: 3 days) plus 30 days. Number. Unit: percentage of participants

Measure	Remdesivir n = 279	Placebo n = 283
Value	42.3	46.3

Population analysed: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study treatment.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events: First dose date up to 3 days plus 30 days; All-Cause Mortality: Randomization to the end of study (maximum: 59 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remdesivir	5 of 279 (1.8%)	48 of 279 (17.2%)	0 of 292
Placebo	19 of 283 (6.7%)	49 of 283 (17.3%)	1 of 292

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39699245Rodriguez 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.
Derived from this study: PubMed 37074613Brown 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.
Derived from this study: PubMed 36695483Grundeis 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.
Derived from this study: PubMed 34937145Gottlieb 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

104 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RDV in people with COVID-19, run by Gilead Sciences at 104 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Denmark, United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Randomization up to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501952, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.