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NCT04292899

Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19)

Last Updated: 2020-12-31

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4891 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2020-06-30

Brief Summary

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The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

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

NONE

Study Groups

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Part A: Remdesivir (RDV), 5 Days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

Administered as an intravenous infusion

Standard of Care

Intervention Type DRUG

Standard of Care Treatment for COVID-19 Infection

Part A: Remdesivir, 10 Days

Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

Administered as an intravenous infusion

Standard of Care

Intervention Type DRUG

Standard of Care Treatment for COVID-19 Infection

Part B: Remdesivir, 10 Days (Extension)

Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

Administered as an intravenous infusion

Standard of Care

Intervention Type DRUG

Standard of Care Treatment for COVID-19 Infection

Part B: Remdesivir 10 days (Mechanically Ventilated)

Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10

Group Type EXPERIMENTAL

Remdesivir

Intervention Type DRUG

Administered as an intravenous infusion

Standard of Care

Intervention Type DRUG

Standard of Care Treatment for COVID-19 Infection

Interventions

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Remdesivir

Administered as an intravenous infusion

Intervention Type DRUG

Standard of Care

Standard of Care Treatment for COVID-19 Infection

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, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥ 18), or willing and able to provide assent (age ≥ 12 to \< 18, where locally and nationally approved) prior to performing study procedures
* Aged ≥ 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 institutional review board (IRB) or independent ethics committee (IEC))
* Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization
* Currently hospitalized
* Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen at screening

Exclusion Criteria

* Participation in any other clinical trial of an experimental treatment for COVID-19
* Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited \< 24 hours prior to study drug dosing
* Evidence of multiorgan failure
* Mechanically ventilated \[including veno-venous (V-V) extracorporeal membrane oxygenation (ECMO)\] ≥ 5 days, or any duration of veno-arterial (V-A) ECMO.
* Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 X upper limit of normal (ULN)
* Creatinine clearance \< 50 mL/min using the Cockcroft-Gault formula for participants ≥ 18 years of age {Cockcroft 1976} and Schwartz Formula for participants \< 18 years of age

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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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Kaiser Permanente Los Angeles Medical Center, 3340 E. La Palma Avenue

Anaheim, California, United States

Site Status

Alta Bates Summit Medical Center

Berkeley, California, United States

Site Status

Mills-Peninsula Medical Center

Burlingame, California, United States

Site Status

Eden Medical Center

Castro Valley, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 9333 Imperial Highway

Downey, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 9961 Sierra Ave

Fontana, California, United States

Site Status

St Joseph Hospital Eureka

Fortuna, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 25825 S. Vermont Ave.

Harbor City, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 6041 Cadillac Ave.

Los Angeles, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 5601 De Soto Avenue

Los Angeles, California, United States

Site Status

Mission Hospital Regional Medical Center

Mission Viejo, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 27300 Iris Avenue

Moreno Valley, California, United States

Site Status

El Camino Hospital

Mountain View, California, United States

Site Status

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status

Kaiser Permanente Oakland Medical Center

Oakland, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 2295 S. Vineyard Avenue

Ontario, California, United States

Site Status

The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

Orange, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 13651 Willard Street

Panorama City, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 10800 Magnolia Avenue

Riverside, California, United States

Site Status

Sutter Medical Center Sacramento, One Medical Plaza

Roseville, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 4647 Zion Avenue

San Diego, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center, 9455 Clairemont Mesa Blvd

San Diego, California, United States

Site Status

Kaiser Permanente Oakland Medical Center, 1200 El Camino Real

San Francisco, California, United States

Site Status

California Pacific Medical Center-Infectious Disease Associates Medical Group

San Francisco, California, United States

Site Status

Kaiser Permanente Oakland Medical Center, 2425 Geary Blvd

San Francisco, California, United States

Site Status

Kaiser Permanente Oakland Medical Center, 250 Hospital Parkway, Suite 850

San Jose, California, United States

Site Status

Kaiser Permanente Oakland Medical Center, 2500 Merced St

San Leandro, California, United States

Site Status

Kaiser Permanente Oakland Medical Center, 700 Lawrence Expressway

Santa Clara, California, United States

Site Status

Providence St. Johns Medical Center

Santa Monica, California, United States

Site Status

Sutter Santa Rosa Regional Hospital

Santa Rosa, California, United States

Site Status

Stanford Hospital

Stanford, California, United States

Site Status

University of Colorado Denver, University of Colorado Hospital

Aurora, Colorado, United States

Site Status

SCL Health St. Joseph Hospital, 1375 East 19th Ave

Denver, Colorado, United States

Site Status

SCL Health St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

SCL Health St. Joseph Hospital, 200 Exempla Circle.

Lafayette, Colorado, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Kaiser Permanente Hawaii Moanalua Medical Center

Honolulu, Hawaii, United States

Site Status

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

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Holy Cross Hospital

Silver Spring, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Brigham & Women's Hospital and Harvard Medical School

Boston, Massachusetts, United States

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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The University of Michigan Hospitals and Health Systems

Ann Arbor, Michigan, United States

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Henry Ford Health System

Detroit, Michigan, United States

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Hennepin Healthcare

Minneapolis, Minnesota, United States

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Mayo Clinic

Rochester, Minnesota, United States

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Providence St Patrick Hospital and International Heart Institute of MT Foundation

Missoula, Montana, United States

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Darmouth-Hitchhock Medical Center

Lebanon, New Hampshire, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

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Robert Wood Johnson University Hospital Somerset

Hillsborough, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital Somerset, 1 RWJ Place

New Brunswick, New Jersey, United States

Site Status

Robert Wood Johnson University Hospital Somerset, 201 Lyons Avenue

Newark, New Jersey, United States

Site Status

St. Joseph's University Medical Center

Paterson, New Jersey, United States

Site Status

Jamaica Hospital Medical Center

Jamaica, New York, United States

Site Status

Danbury Hospital

Lagrangeville, New York, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status