NCT05715528|CompletedPhase 3ResultsDMCFDA Drug

Study of Obeldesivir in Nonhospitalized Participants With COVID-19

OAKTREE

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Nonhospitalized Participants

Gilead Sciences ClinicalTrials.gov

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2 other identifiers

GS-US-611-6549jRCT2031230285

Study Type

interventional

Target

2,011

Locations

2 countries

Sites

113

Timeline

RegisteredFeb 2023

StartedFeb 2023

CompletionJan 2024

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,011

participants targeted

Target at P75+ for phase_3 covid19

Timeline

Completed

Started Feb 2023

Typical duration for phase_3 covid19

Geographic Reach

2 countries

113 active sites

Status

completed

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

12 months study duration

First Submitted

Initial submission to the registry

February 3, 2023

Completed

5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed

Same day until next milestone

Study Start

First participant enrolled

February 8, 2023

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2024

Completed

11 months until next milestone

Results Posted

Study results publicly available

December 24, 2024

Completed

Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

February 3, 2023

Results QC Date

October 28, 2024

Last Update Submit

December 13, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (4)

Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29
The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish. Kaplan-Meier (KM) estimates were used in outcome measure analysis.
First dose date up to Day 29
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as 1 or both of the following: * 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. * Any AEs leading to premature discontinuation of study drug. Percentages were rounded off.
First dose date up to Day 5 plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days. Percentages were rounded off.
First dose date up to Day 5 plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
Percentages were rounded off.
First dose date up to Day 5 plus 30 days

Secondary Outcomes (12)

Time to COVID-19 Symptom Resolution by Day 29
Day 1 up to 29
Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29
Up to Day 29
Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29
Up to Day 29
Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29
Up to Day 29
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
Day 5
+7 more secondary outcomes

Study Arms (2)

Obeldesivir

EXPERIMENTAL

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

Drug: Obeldesivir

Obeldesivir Placebo

PLACEBO COMPARATOR

Participants will receive obeldesivir placebo twice daily for 5 days.

Drug: Obeldesivir Placebo

Interventions

ObeldesivirDRUG

Tablet administered orally without regard to food.

Also known as: GS-5245

Obeldesivir

Obeldesivir PlaceboDRUG

Tablet administered orally without regard to food.

Obeldesivir Placebo

Eligibility Criteria

Age12 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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.

You may not qualify if:

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.
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Gilead Scienceslead

Study Sites (113)

EmVenio Research

Alabaster, Alabama, 35007, United States

Location

Institute for Liver Health dba Arizona Clinical Trials

Chandler, Arizona, 85224, United States

Location

The Institute for Liver Health dba Arizona Liver Health

Tucson, Arizona, 85712, United States

Location

Franco Felizarta, MD

Bakersfield, California, 93301, United States

Location

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

Banning, California, 92220, United States

Location

Benchmark Research

Colton, California, 92324, United States

Location

Ascada Research

Fullerton, California, 92835, United States

Location

Velocity Clinical Research

La Mesa, California, 91942, United States

Location

IMAX Clinical Trials, LLC

La Palma, California, 90623, United States

Location

Om Research LLC

Lancaster, California, 93534, United States

Location

L.A. Universal Research Center, INC.

Los Angeles, California, 90057, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Valley Clinical Trials

Northridge, California, 91325, United States

Location

Fomat Medical Research

Oxnard, California, 93030, United States

Location

Paradigm Clinical Research

Redding, California, 96001, United States

Location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Clearview Medical Research, LLC

Santa Clarita, California, 91351, United States

Location

EmVenio Research

Santa Monica, California, 90404, United States

Location

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

Toluca Lake, California, 91602, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Encore Medical Research of Boynton Beach LLC

Boynton Beach, Florida, 33436, United States

Location

Palm Harbor Dermatology d/b/a TrueBlue Clinical Research

Brandon, Florida, 33511, United States

Location

Innovative Research of West Florida, Inc

Clearwater, Florida, 33756, United States

Location

Prestige Clinical Research Center Inc

Coral Gables, Florida, 33134, United States

Location

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, 33157, United States

Location

Vital Care Research

Doral, Florida, 33122, United States

Location

UHC Research, LLC

Doral, Florida, 33126, United States

Location

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, 33308, United States

Location

Qway Research LLC

Hialeah, Florida, 33010, United States

Location

AGA Clinical Trials

Hialeah, Florida, 33012, United States

Location

Research in Miami

Hialeah, Florida, 33013, United States

Location

3Sync, LLC

Hialeah, Florida, 33016, United States

Location

Best Quality Research, Inc.

Hialeah, Florida, 33016, United States

Location

Doral Medical Research

Hialeah, Florida, 33016, United States

Location

Evolution Clinical Trials, INC

Hialeah Gardens, Florida, 33016, United States

Location

Innovative Health

Hollywood, Florida, 33024, United States

Location

Encore Medical Research, LLC

Hollywood, Florida, 33201, United States

Location

Advance Clinical Research Group

Miami, Florida, 33122, United States

Location

Med-Care Research, Corp

Miami, Florida, 33125, United States

Location

Southern Clinical Research LLC

Miami, Florida, 33125, United States

Location

LCC Medical Research Institute, LLC

Miami, Florida, 33126, United States

Location

Universal Medical and Research Center, LLC.

Miami, Florida, 33126, United States

Location

CCM Clinical Research Group, LLC

Miami, Florida, 33133, United States

Location

Global Health Clinical Trials Corp

Miami, Florida, 33135, United States

Location

Retreat Medical Research

Miami, Florida, 33135, United States

Location

Verus Clinical Research, Corp

Miami, Florida, 33135, United States

Location

Clinical Trial Services, Corp

Miami, Florida, 33144, United States

Location

Continental Clinical Research

Miami, Florida, 33144, United States

Location

Dynamic Medical Research, LLC

Miami, Florida, 33144, United States

Location

Nuren Medical & Research Center

Miami, Florida, 33144, United States

Location

Advanced Care and Clinical Trials, LLC