COVID-19 Clinical Trial
— OAKTREEOfficial 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
| Verified date | February 2024 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The goal of this clinical study is to test if obeldesivir (formerly 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.
| Status | Completed |
| Enrollment | 2011 |
| Est. completion date | January 23, 2024 |
| Est. primary completion date | November 29, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years to 64 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kanagawa Himawari Clinic | Kawasaki-Shi | |
| Japan | Medical corporation Shirayurikai Swing Nozaki Clinic | Musashino | |
| Japan | Nishioka Hospital | Sapporo-Shi Toyohira-Ku | |
| Japan | Sato Clinic | Shibuya-ku | |
| Japan | Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai | Shinagawa-Ku | |
| United States | EmVenio Research | Alabaster | Alabama |
| United States | Agile Clinical Research Trials, LLC | Atlanta | Georgia |
| United States | EmVenio Research | Atlanta | Georgia |
| United States | Franco Felizarta, MD | Bakersfield | California |
| United States | Velocity Clinical Research, Banning (IP Delivery and Administering Location) | Banning | California |
| United States | St Hope Foundation, Inc. | Bellaire | Texas |
| United States | Bountiful Internal Medicine | Bountiful | Utah |
| United States | Encore Medical Research of Boynton Beach LLC | Boynton Beach | Florida |
| United States | Palm Harbor Dermatology d/b/a TrueBlue Clinical Research | Brandon | Florida |
| United States | Prime Global Research Inc | Bronx | New York |
| United States | PanAmerican Clinical Research | Brownsville | Texas |
| United States | Institute for Liver Health dba Arizona Clinical Trials | Chandler | Arizona |
| United States | Innovative Research of West Florida, Inc | Clearwater | Florida |
| United States | Benchmark Research | Colton | California |
| United States | Prestige Clinical Research Center Inc | Coral Gables | Florida |
| United States | Beautiful Minds Clinical Research Center | Cutler Bay | Florida |
| United States | Premier Pulmonary Critical Care and Sleep Medicine | Denison | Texas |
| United States | Shelby Clinical Research, LLC | Denver | North Carolina |
| United States | UHC Research, LLC | Doral | Florida |
| United States | Vital Care Research | Doral | Florida |
| United States | Covenant Pulmonary Critical Care Research Institute | East Point | Georgia |
| United States | Proactive Clinical Research,LLC | Fort Lauderdale | Florida |
| United States | EmVenio Research | Fort Worth | Texas |
| United States | Ascada Research | Fullerton | California |
| United States | The Brody School of Medicine at East Carolina University | Greenville | North Carolina |
| United States | 3Sync, LLC | Hialeah | Florida |
| United States | AGA Clinical Trials | Hialeah | Florida |
| United States | Best Quality Research, Inc. | Hialeah | Florida |
| United States | Doral Medical Research | Hialeah | Florida |
| United States | Qway Research LLC | Hialeah | Florida |
| United States | Research in Miami | Hialeah | Florida |
| United States | Evolution Clinical Trials, INC | Hialeah Gardens | Florida |
| United States | Encore Medical Research, LLC | Hollywood | Florida |
| United States | Innovative Health | Hollywood | Florida |
| United States | HDH Research Inc. | Houston | Texas |
| United States | The Crofoot Research Center, INC. | Houston | Texas |
| United States | Frontier Clinical Research, LLC | Kingwood | West Virginia |
| United States | Velocity Clinical Research | La Mesa | California |
| United States | IMAX Clinical Trials, LLC | La Palma | California |
| United States | Velocity Clinical Research | Lafayette | Louisiana |
| United States | Om Research LLC | Lancaster | California |
| United States | Milton Haber, MD | Laredo | Texas |
| United States | L.A. Universal Research Center, INC. | Los Angeles | California |
| United States | SMS Clinical Research, LLC | Mesquite | Texas |
| United States | Advance Clinical Research Group | Miami | Florida |
| United States | Advanced Care and Clinical Trials, LLC | Miami | Florida |
| United States | Allied Biomedical Research Institute | Miami | Florida |
| United States | Bioclinical Research Alliance Inc. | Miami | Florida |
| United States | CCM Clinical Research Group, LLC | Miami | Florida |
| United States | Clinical Site Partners, LLC dba Flourish Research | Miami | Florida |
| United States | Clinical Trial Services, Corp | Miami | Florida |
| United States | Continental Clinical Research | Miami | Florida |
| United States | Cordova Research Institute, Inc | Miami | Florida |
| United States | D&H National Research Centers, INC | Miami | Florida |
| United States | Diverse Clinical Research, LLC | Miami | Florida |
| United States | Dynamic Medical Research, LLC | Miami | Florida |
| United States | Entrust Clinical Research | Miami | Florida |
| United States | Florida International Medical Research | Miami | Florida |
| United States | Global Health Clinical Trials Corp | Miami | Florida |
| United States | LCC Medical Research Institute, LLC | Miami | Florida |
| United States | Links Clinical Trials LLC | Miami | Florida |
| United States | Med-Care Research, Corp | Miami | Florida |
| United States | MedBio Trials LLC | Miami | Florida |
| United States | Miami Clinical Research | Miami | Florida |
| United States | Nuren Medical & Research Center | Miami | Florida |
| United States | P&S Research, LLC. | Miami | Florida |
| United States | Phoenix Research Center, LLC | Miami | Florida |
| United States | ProLive Medical Research, Corp | Miami | Florida |
| United States | Reed Medical Research Corp | Miami | Florida |
| United States | Retreat Medical Research | Miami | Florida |
| United States | Southern Clinical Research LLC | Miami | Florida |
| United States | Universal Medical and Research Center, LLC. | Miami | Florida |
| United States | Verus Clinical Research, Corp | Miami | Florida |
| United States | Angels Clinical Research Institute | Miami Lakes | Florida |
| United States | Essential Clinical Research | Miami Lakes | Florida |
| United States | Palm Springs Community Health Center | Miami Lakes | Florida |
| United States | Quality Research of South Florida | Miami Lakes | Florida |
| United States | Tulane University School of Medicine | New Orleans | Louisiana |
| United States | Oceanic Research Group | North Miami Beach | Florida |
| United States | Amicis Research Center | Northridge | California |
| United States | Valley Clinical Trials | Northridge | California |
| United States | Fomat Medical Research | Oxnard | California |
| United States | Castillo Torres, MD PA | Palm Springs | Florida |
| United States | Family Clinical Trials, LLC | Pembroke Pines | Florida |
| United States | North Texas Family Medicine | Plano | Texas |
| United States | Village Health Partners | Plano | Texas |
| United States | Village Health Partners | Plano | Texas |
| United States | Epic Medical Research, LLC | Red Oak | Texas |
| United States | Paradigm Clinical Research | Redding | California |
| United States | STAAMP Research LLC | San Antonio | Texas |
| United States | Zuckerberg San Francisco General Hospital | San Francisco | California |
| United States | Clearview Medical Research, LLC | Santa Clarita | California |
| United States | EmVenio Research | Santa Monica | California |
| United States | Carolina Research Center, Inc. | Shelby | North Carolina |
| United States | Frontier Clinical Research, LLC | Smithfield | Pennsylvania |
| United States | USPA Advance Concept Medical Research Group, LLC | South Miami | Florida |
| United States | Precision Clinical Research | Sunrise | Florida |
| United States | Angels Clinical Research Institute | Tampa | Florida |
| United States | Precision Research Center | Tampa | Florida |
| United States | Santos Research Center, CORP | Tampa | Florida |
| United States | Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. | Toluca Lake | California |
| United States | The Institute for Liver Health dba Arizona Liver Health | Tucson | Arizona |
| United States | Georgetown University Medical Center | Washington | District of Columbia |
| United States | Tranquil Clinical Research | Webster | Texas |
| United States | Clinovacare Medical Research Center | West Columbia | South Carolina |
| United States | Velocity Clinical Research, Salt Lake City | West Jordan | Utah |
| United States | Encore Medical Reseach of Weston, LLC | Weston | Florida |
| United States | Clinical Site Partners, LLC dba Flourish Research | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 | First dose date up to Day 29 | ||
| Primary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to Day 5 plus 30 days | ||
| Primary | Percentage of Participants Experiencing Laboratory Abnormalities | First dose date up to Day 5 plus 30 days | ||
| Primary | Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation | First dose date up to Day 5 plus 30 days | ||
| Secondary | Time to COVID-19 Symptom Resolution by Day 29 | Day 1 up to 29 | ||
| Secondary | Proportion of Participants with COVID-19 related Medically Attended Visits (MAVs) or All-cause Death by Day 29 | Up to Day 29 | ||
| Secondary | Proportion of Participants with Moderate Relapse of COVID-19 Symptoms by Day 29 | Up to Day 29 | ||
| Secondary | Proportion of Participants with COVID-19 related Hospitalization or All-cause Death by Day 29 | Up to Day 29 | ||
| Secondary | Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 | Baseline, Day 5 | ||
| Secondary | Time to Antigen Negativity | Day 1 up to Day 29 | ||
| Secondary | Proportion of Participants with Viral Antigen Rebound | First dose date up to Day 29 | ||
| Secondary | Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) | Day 1, Day 3, and Day 5 | ||
| Secondary | Pharmacokinetic (PK) Parameter: AUCtau of GS-441524 | AUCtau is defined as the area under the concentration versus time curve over the dosing interval | Day 1, Day 3, and Day 5 | |
| Secondary | PK Parameter: Ctau of GS-441524 | Ctau is defined as the observed drug concentration at the end of the dosing interval | Day 1, Day 3, and Day 5 | |
| Secondary | PK Parameter: Cmax of GS-441524 | Cmax is defined as the maximum observed plasma concentration of drug | Day 1, Day 3, and Day 5 | |
| Secondary | Proportion of Participants with Relapse of COVID-19 Symptoms by Day 29 | Up to Day 29 |
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