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NCT05715528

Study of Obeldesivir in Nonhospitalized Participants With COVID-19

Last Updated: 2024-12-24

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

2011 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2024-01-23

Brief Summary

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The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.

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

Participants, personnel directly involved in the conduct of study, and sponsor will not know the treatment participants received.

Study Groups

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Obeldesivir

Participants will receive obeldesivir 350 mg twice daily for 5 days.

Group Type EXPERIMENTAL

Obeldesivir

Intervention Type DRUG

Tablet administered orally without regard to food.

Obeldesivir Placebo

Participants will receive obeldesivir placebo twice daily for 5 days.

Group Type PLACEBO_COMPARATOR

Obeldesivir Placebo

Intervention Type DRUG

Tablet administered orally without regard to food.

Interventions

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Obeldesivir

Tablet administered orally without regard to food.

Intervention Type DRUG

Obeldesivir Placebo

Tablet administered orally without regard to food.

Intervention Type DRUG

Other Intervention Names

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GS-5245

Eligibility Criteria

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Inclusion Criteria

* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an approved alternative assay. Serologic tests will not be accepted.
* Willing and able to complete the coronavirus disease 19 (COVID-19) symptom questionnaire prior to first dose and daily throughout the study period.
* Initial onset of COVID-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization.

* Stuffy or runny nose.
* Sore throat.
* Shortness of breath (difficulty breathing).
* Cough.
* Low energy or tiredness.
* Muscle or body aches.
* Headache.
* Chills or shivering.
* Feeling hot or feverish.
* Not currently hospitalized or requiring hospitalization.

Exclusion Criteria

* Any risk factors for progression to severe disease.
* Planning to receive a direct acting antiviral or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19.
* Received any direct acting antiviral drug or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19 \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
* Received any convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 prophylaxis at any time prior to study entry.
* Received an COVID-19 vaccine (including booster dose) \< 120 days before randomization.
* Self-reported COVID-19 diagnosis \< 120 days before randomization.
* Anticipated need for hospitalization \< 48 hours after randomization.
* New oxygen requirement \< 24 hours before randomization.
* Known influenza, or any other suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study drug.
* Known history of chronic liver disease, limited to cirrhosis, nonalcoholic steatohepatitis, alcoholic liver disease, and autoimmune hepatitis.
* Undergoing dialysis, or known history of chronic kidney disease.
* Persistent symptoms from previous COVID-19 illness that may interfere with the evaluation of response to the study drug.
* Pregnant or breastfeeding.
* Unwilling to use protocol-mandated contraception.
* Any other factor, including inability to complete the patient-reported outcome (PRO) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study.
* Concurrent participation/enrollment in a separate therapeutic clinical study.

Minimum Eligible Age

12 Years

Maximum Eligible Age

64 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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EmVenio Research

Alabaster, Alabama, United States

Site Status

Institute for Liver Health dba Arizona Clinical Trials

Chandler, Arizona, United States

Site Status

The Institute for Liver Health dba Arizona Liver Health

Tucson, Arizona, United States

Site Status

Franco Felizarta, MD

Bakersfield, California, United States

Site Status

Velocity Clinical Research, Banning (IP Delivery and Administering Location)

Banning, California, United States

Site Status

Benchmark Research

Colton, California, United States

Site Status

Ascada Research

Fullerton, California, United States

Site Status

Velocity Clinical Research

La Mesa, California, United States

Site Status

IMAX Clinical Trials, LLC

La Palma, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

L.A. Universal Research Center, INC.

Los Angeles, California, United States

Site Status

Amicis Research Center

Northridge, California, United States

Site Status

Valley Clinical Trials

Northridge, California, United States

Site Status

Fomat Medical Research

Oxnard, California, United States

Site Status

Paradigm Clinical Research

Redding, California, United States

Site Status

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status

Clearview Medical Research, LLC

Santa Clarita, California, United States

Site Status

EmVenio Research

Santa Monica, California, United States

Site Status

Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.

Toluca Lake, California, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Encore Medical Research of Boynton Beach LLC

Boynton Beach, Florida, United States

Site Status

Palm Harbor Dermatology d/b/a TrueBlue Clinical Research

Brandon, Florida, United States

Site Status

Innovative Research of West Florida, Inc

Clearwater, Florida, United States

Site Status

Prestige Clinical Research Center Inc

Coral Gables, Florida, United States

Site Status

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

Site Status

Vital Care Research

Doral, Florida, United States

Site Status

UHC Research, LLC

Doral, Florida, United States

Site Status