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

NCT ID: NCT04501952

Last Updated: 2021-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-18

Study Completion Date

2021-05-06

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Remdesivir (RDV)

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.

Group Type EXPERIMENTAL

RDV

Intervention Type DRUG

Administered as an intravenous infusion

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo to Match RDV

Intervention Type DRUG

Administered as an intravenous infusion

Interventions

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RDV

Administered as an intravenous infusion

Intervention Type DRUG

Placebo to Match RDV

Administered as an intravenous infusion

Intervention Type DRUG

Other Intervention Names

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GS-5734™ Veklury®

Eligibility Criteria

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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)

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Arizona Liver Health

Chandler, Arizona, United States

Site Status

Arizona Clinical Trials

Tucson, Arizona, United States

Site Status

St Joseph Hospital Eureka

Eureka, California, United States

Site Status

St. Joseph Heritage Healthcare

Fullerton, California, United States

Site Status

Elevated Health

Huntington Beach, California, United States

Site Status

Ruane Clinical Research Group

Los Angeles, California, United States

Site Status

LA Universal Center, INC.

Los Angeles, California, United States

Site Status

Mills Clinical Research

Los Angeles, California, United States

Site Status

Kaiser Permanente Northern California

Oakland, California, United States

Site Status

FOMAT Medical Research

Oxnard, California, United States

Site Status

UC Davis Health

Sacramento, California, United States

Site Status

Kaiser Permanente Northern California, 6600 Bruceville Road

Sacramento, California, United States

Site Status

Kaiser Permanente Northern California, 2025 Morse Ave

Sacramento, California, United States

Site Status

Kaiser Permanente Northern California, 1200 El Camino Real

San Francisco, California, United States

Site Status

Kaiser Permanente Northern California, 2425 Geary Blvd

San Francisco, California, United States

Site Status

UCSF Medical Center

San Francisco, California, United States

Site Status

Kaiser Permanente Northern California, 250 Hospital Parkway, Suite 850

San Jose, California, United States

Site Status

Kaiser Permanente Northern California, 2500 Merced St

San Leandro, California, United States

Site Status

St. Joseph Heritage Healthcare

Santa Rosa, California, United States

Site Status

Premiere Medical Center of Burbank, Inc

Toluca Lake, California, United States

Site Status

Kaiser Permanente Northern California, 975 Sereno Drive

Vallejo, California, United States

Site Status

New Hope Research Development DBA HCD

Whittier, California, United States

Site Status

Centura Health Porter Place

Denver, Colorado, United States

Site Status

Nuvance Health

Danbury, Connecticut, United States

Site Status

RecioMed Clinical Research Network

Boynton Beach, Florida, United States

Site Status

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States

Site Status

Invesclinic

Fort Lauderdale, Florida, United States

Site Status

Lawnwood Regional Medical Center

Ft. Pierce, Florida, United States

Site Status

Evolution Clinical Trials

Hialeah Gardens, Florida, United States

Site Status

Encore Medical Research

Hollywood, Florida, United States

Site Status

Advanced Pulmonary Research Institute

Loxahatchee Groves, Florida, United States

Site Status

L&C Professional Medical Research Institute

Miami, Florida, United States

Site Status

Laguna Clinical Research Associates

Miami, Florida, United States

Site Status

CTMD Research, Inc

Palm Springs, Florida, United States

Site Status

IMIC Inc

Palmetto Bay, Florida, United States

Site Status

Luminous Clinical Research - South Florida Urgent Care

Pembroke Pines, Florida, United States

Site Status

St. Josephs Comprehensive Research Institute

Tampa, Florida, United States

Site Status

AIDS Research and Treatment Center of the Treasure Coast

Vero Beach, Florida, United States

Site Status

Triple O Research Institute PA

West Palm Beach, Florida, United States

Site Status

Agile Clinical Research Trials

Atlanta, Georgia, United States

Site Status

Mercer University School of Medicine

Macon, Georgia, United States

Site Status

Infectious Disease Associates of Kansas City, P.C.Infectious Disease Associates of Kansas City, P.C.

Burr Ridge, Illinois, United States

Site Status

Metro Infectious Disease Consultants

Burr Ridge, Illinois, United States

Site Status

NorthStar Medical Center

Chicago, Illinois, United States

Site Status

NorthShore University Healthsystem

Evanston, Illinois, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

Holy Cross Hospital, Inc.

Baltimore, Maryland, United States

Site Status

University of Maryland Baltimore

Baltimore, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

South Shore Hospital

South Weymouth, Massachusetts, United States

Site Status

VA Boston Healthcare System

West Roxbury, Massachusetts, United States

Site Status

Be Well Medical Center

Berkley, Michigan, United States

Site Status

Onyx Research Institute

Flint, Michigan, United States

Site Status

Memorial Hospital of Gulfport

Gulfport, Mississippi, United States

Site Status

Metro Infectious Disease Consultants

Kansas City, Missouri, United States

Site Status

Quality Clinical Research Inc.

Omaha, Nebraska, United States

Site Status

AB Clinical Trials

Las Vegas, Nevada, United States

Site Status

AXCES Research Group

Santa Fe, New Mexico, United States

Site Status

New York Presbyterian Hospital

Flushing, New York, United States

Site Status

Northwell Health

New Hyde Park, New York, United States

Site Status

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

East Carolina University

Greenville, North Carolina, United States

Site Status

Rosedale Infectious Diseases

Huntersville, North Carolina, United States

Site Status

Christ Hospital

Cincinnati, Ohio, United States

Site Status

Cherokee Nation WW Hastings Hospital

Tahlequah, Oklahoma, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

University of Tennessee Health Science Center

Knoxville, Tennessee, United States

Site Status

Central Texas Clinical Research

Austin, Texas, United States

Site Status

UT Physicians

Bellaire, Texas, United States

Site Status

Baylor University Medical Center, 700 Scott and White Dr.

College Station, Texas, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Care United Research, LLC

Forney, Texas, United States

Site Status

VIP Trials

Harlingen, Texas, United States

Site Status

University of Texas

Houston, Texas, United States

Site Status

The Crofoot Research Center, Inc

Houston, Texas, United States

Site Status

Baylor University Medical Center, 1901 North McArthur Blvd

Irving, Texas, United States

Site Status

Laguna Clinical Research Associates

Laredo, Texas, United States

Site Status

Diagnostic Clinic of Longview - Center for Clinical Research

Longview, Texas, United States

Site Status

STAAMP Research

San Antonio, Texas, United States

Site Status

Sugar Lakes Family Practice

Sugar Land, Texas, United States

Site Status

Baylor University Medical Center, 2201 MacArthur Dr., Suite 100

Waco, Texas, United States

Site Status

ClinPoint Trials

Waxahachie, Texas, United States

Site Status

Intermountain Healthcare

Murray, Utah, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Providence Regional Medical Center Everett

Everett, Washington, United States

Site Status

Sound Medical Research

Port Orchard, Washington, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Providence Medical Research Center

Spokane, Washington, United States

Site Status

Wisconsin Corporation for Biomedical Research

Milwaukee, Wisconsin, United States

Site Status

Aalborg University Hospital

Aalborg, , Denmark

Site Status

Aarhus University Hospital

Aarhus N, , Denmark

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Clinic

Barcelona, , Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, , United Kingdom

Site Status

University College Hospital

London, , United Kingdom

Site Status

St Mary's Hospital

London, , United Kingdom

Site Status

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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Portugal United States Denmark Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 39699245 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37074613 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36695483 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34937145 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2020-003510-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-540-9012

Identifier Type: -

Identifier Source: org_study_id