Clinical trial NCT05715528: Study of Obeldesivir in Nonhospitalized Participants With COVID-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 2011
Sex: ALL
Minimum age (years): 12
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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.

Key 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29
timeFrame: First dose date up to Day 29
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to Day 5 plus 30 days
measure: Percentage of Participants Experiencing Laboratory Abnormalities
timeFrame: First dose date up to Day 5 plus 30 days
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
timeFrame: First dose date up to Day 5 plus 30 days
Secondary outcomes:
measure: Time to COVID-19 Symptom Resolution by Day 29
timeFrame: Day 1 up to 29
measure: Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29
timeFrame: Up to Day 29
measure: Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
timeFrame: Day 5
measure: Time to Antigen Negativity
timeFrame: Day 1 up to Day 29
measure: Percentage of Participants With Viral Antigen Rebound
timeFrame: Up to Day 29
measure: Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
timeFrame: Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hour
measure: Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524
timeFrame: Day 5
measure: PK Parameter: Ctau of GS-441524
timeFrame: Day 1 and Day 5
measure: PK Parameter: Cmax of GS-441524
timeFrame: Day 1 and Day 5
measure: Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29
timeFrame: Up to Day 29
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: EmVenio Research
state: Alabama
city: Chandler
country: United States
facility: Institute for Liver Health dba Arizona Clinical Trials
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health dba Arizona Liver Health
state: Arizona
city: Bakersfield
country: United States
facility: Franco Felizarta, MD
state: California
city: Banning
country: United States
facility: Velocity Clinical Research, Banning (IP Delivery and Administering Location)
state: California
city: Colton
country: United States
facility: Benchmark Research
state: California
city: Fullerton
country: United States
facility: Ascada Research
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research
state: California
city: La Palma
country: United States
facility: IMAX Clinical Trials, LLC
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Angeles
country: United States
facility: L.A. Universal Research Center, INC.
state: California
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Oxnard
country: United States
facility: Fomat Medical Research
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research
state: California
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
city: Santa Clarita
country: United States
facility: Clearview Medical Research, LLC
state: California
city: Santa Monica
country: United States
facility: EmVenio Research
state: California
city: Toluca Lake
country: United States
facility: Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach LLC
state: Florida
city: Brandon
country: United States
facility: Palm Harbor Dermatology d/b/a TrueBlue Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc
state: Florida
city: Coral Gables
country: United States
facility: Prestige Clinical Research Center Inc
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center
state: Florida
city: Doral
country: United States
facility: Vital Care Research
state: Florida
city: Doral
country: United States
facility: UHC Research, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research,LLC
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials, INC
state: Florida
city: Hialeah
country: United States
facility: Qway Research LLC
state: Florida
city: Hialeah
country: United States
facility: AGA Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Research in Miami
state: Florida
city: Hialeah
country: United States
facility: 3Sync, LLC
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research, Inc.
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research
state: Florida
city: Hollywood
country: United States
facility: Innovative Health
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research, LLC
state: Florida
city: Miami Lakes
country: United States
facility: Essential Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami Lakes
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: Quality Research of South Florida
state: Florida
city: Miami
country: United States
facility: Advance Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Med-Care Research, Corp
state: Florida
city: Miami
country: United States
facility: Southern Clinical Research LLC
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Universal Medical and Research Center, LLC.
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Global Health Clinical Trials Corp
state: Florida
city: Miami
country: United States
facility: Retreat Medical Research
state: Florida
city: Miami
country: United States
facility: Verus Clinical Research, Corp
state: Florida
city: Miami
country: United States
facility: Clinical Trial Services, Corp
state: Florida
city: Miami
country: United States
facility: Continental Clinical Research
state: Florida
city: Miami
country: United States
facility: Dynamic Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Nuren Medical & Research Center
state: Florida
city: Miami
country: United States
facility: Advanced Care and Clinical Trials, LLC
state: Florida
city: Miami
country: United States
facility: Bioclinical Research Alliance Inc.
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute, Inc
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers, INC
state: Florida
city: Miami
country: United States
facility: Florida International Medical Research
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: Diverse Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: P&S Research, LLC.
state: Florida
city: Miami
country: United States
facility: ProLive Medical Research, Corp
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Links Clinical Trials LLC
state: Florida
city: Miami
country: United States
facility: Reed Medical Research Corp
state: Florida
city: Miami
country: United States
facility: MedBio Trials LLC
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Miami
country: United States
facility: Phoenix Research Center, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Oceanic Research Group
state: Florida
city: Palm Springs
country: United States
facility: Castillo Torres, MD PA
state: Florida
city: Pembroke Pines
country: United States
facility: Family Clinical Trials, LLC
state: Florida
city: South Miami
country: United States
facility: USPA Advance Concept Medical Research Group, LLC
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Tampa
country: United States
facility: Precision Research Center
state: Florida
city: Tampa
country: United States
facility: Santos Research Center, CORP
state: Florida
city: Weston
country: United States
facility: Encore Medical Reseach of Weston, LLC
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Atlanta
country: United States
facility: EmVenio Research
state: Georgia
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: East Point
country: United States
facility: Covenant Pulmonary Critical Care Research Institute
state: Georgia
city: Lafayette
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Bronx
country: United States
facility: Prime Global Research Inc
state: New York
city: Denver
country: United States
facility: Shelby Clinical Research, LLC
state: North Carolina
city: Greenville
country: United States
facility: The Brody School of Medicine at East Carolina University
state: North Carolina
city: Shelby
country: United States
facility: Carolina Research Center, Inc.
state: North Carolina
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: West Columbia
country: United States
facility: Clinovacare Medical Research Center
state: South Carolina
city: Bellaire
country: United States
facility: St Hope Foundation, Inc.
state: Texas
city: Brownsville
country: United States
facility: PanAmerican Clinical Research
state: Texas
city: Denison
country: United States
facility: Premier Pulmonary Critical Care and Sleep Medicine
state: Texas
city: Fort Worth
country: United States
facility: EmVenio Research
state: Texas
city: Houston
country: United States
facility: HDH Research Inc.
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, INC.
state: Texas
city: Laredo
country: United States
facility: Milton Haber, MD
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
city: Plano
country: United States
facility: North Texas Family Medicine
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: STAAMP Research LLC
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Bountiful Internal Medicine
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Kingwood
country: United States
facility: Frontier Clinical Research, LLC
state: West Virginia
city: Kawasaki-Shi
country: Japan
facility: Kanagawa Himawari Clinic
city: Musashino
country: Japan
facility: Medical corporation Shirayurikai Swing Nozaki Clinic
city: Sapporo-Shi Toyohira-Ku
country: Japan
facility: Nishioka Hospital
city: Shibuya-ku
country: Japan
facility: Sato Clinic
city: Shinagawa-Ku
country: Japan
facility: Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: