Study of Obeldesivir in Nonhospitalized Participants With COVID-19 (OAKTREE)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
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.
Sites / Locations
- EmVenio Research
- Cullman Clinical Trials
- Velocity Clinical Research
- Cahaba Research, Inc.
- Institute for Liver Health dba Arizona Clinical Trials
- Absolute Clinical Research
- Headlands Research - Scottsdale
- Epic Medical Research-Surprise
- The Institute for Liver Health dba Arizona Liver Health
- Advanced Research Center, Inc.
- Franco Felizarta, MD
- Velocity Clinical Research, Banning (IP Delivery and Administering Location)
- Benchmark Research
- El Centro Regional Medical Center
- Ascada Research
- Velocity Clinical Research
- IMAX Clinical Trials, LLC
- Om Research LLC
- Biopharma Informatic, LLC
- Ruane Clinical Research Group Inc.
- L.A. Universal Research Center, INC.
- Amicis Research Center
- Valley Clinical TrialsRecruiting
- Fomat Medical Research
- Paradigm Clinical Research
- Clinica de Salud del Valle de Salinas
- CRMD Research
- Wr-Whcr, Llc
- Zuckerberg San Francisco General Hospital
- Clearview Medical Research, LLC
- EmVenio Research
- Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
- Georgetown University Medical CenterRecruiting
- Encore Medical Research of Boynton Beach LLC
- Palm Harbor Dermatology d/b/a TrueBlue Clinical Research
- Innovative Research of West Florida, Inc
- Prestige Clinical Research Center Inc
- Beautiful Minds Clinical Research Center
- Midland Florida Clinical Research Center, LLC
- Vital Care Research
- UHC Research, LLC
- Proactive Clinical Research,LLC
- Midway Immunology and Research Center
- Evolution Clinical Trials, INC
- Qway Research LLC
- AGA Clinical Trials
- Inpatient Research Clinic- Facility and Drug Shipment
- Research in Miami
- 3Sync, LLC
- Best Quality Research, Inc.
- Doral Medical Research
- Innovative Health
- Encore Medical Research, LLC
- Wr-Msra, Llc
- Clinical Site Partners, LLC dba Flourish Research
- Pro-Care Research Center, Corp.
- Essential Clinical Research
- Palm Springs Community Health Center
- Angels Clinical Research Institute
- Quality Research of South Florida
- Advance Clinical Research Group
- Med-Care Research, Corp
- Southern Clinical Research LLC
- LCC Medical Research Institute, LLC
- Universal Medical and Research Center, LLC.
- CCM Clinical Research Group, LLC
- Global Health Clinical Trials Corp
- Retreat Medical Research
- Verus Clinical Research, Corp
- Clinical Trial Services, CorpRecruiting
- Continental Clinical Research
- Dynamic Medical Research, LLC
- Nuren Medical & Research Center
- Advanced Care and Clinical Trials, LLC
- Bioclinical Research Alliance Inc.
- Cordova Research Institute, Inc
- D&H National Research Centers, INC
- Florida International Medical Research
- Miami Clinical Research
- Allied Biomedical Research Institute
- Diverse Clinical Research, LLC
- P&S Research, LLC.
- ProLive Medical Research, Corp
- Entrust Clinical Research
- Links Clinical Trials LLC
- Reed Medical Research Corp
- MedBio Trials LLC
- Clinical Site Partners, LLC dba Flourish Research
- Nuovida Research Center Corp
- Phoenix Research Center, LLC
- Oceanic Research Group
- Accel Research Sites Network - St. Pete-Largo Clinical Research Unit
- Digestive and Liver Center of Florida
- Ormond Beach Clinical Research
- Castillo Torres, MD PA
- Family Clinical Trials, LLC
- USPA Advance Concept Medical Research Group, LLC
- Precision Clinical Research
- Angels Clinical Research Institute
- Precision Research Center
- Santos Research Center, CORP
- Midway Specialty Care Center
- Triple O Research Institute, P.A.
- Encore Medical Reseach of Weston, LLC
- Clinical Site Partners, LLC dba Flourish Research
- EmVenio Research
- Agile Clinical Research Trials, LLC
- Covenant Pulmonary Critical Care Research Institute
- Accel Research Sites Network - Cardiology Care Clinic
- Velocity Clinical Research
- Metro Infectious Disease Consultants
- MediSphere Medical Research Center, LLC
- Aliance for multispecialty Research, LLC
- Velocity Clinical Research
- Velocity Clinical Research
- Tulane University School of Medicine
- Velocity Clinical Research
- Velocity Clinical Research
- Headlands Research
- Hannibal Regional Healthcare System, Inc.
- Mercury Street Medical Group LLC
- Velocity Clinical Research, Inc.
- Saint Michael's Medical Center
- Velocity Clinical Research
- University of New Mexico Health Sciences Center
- Lincoln Hospital
- Prime Global Research Inc
- James J. Peters VA Medical Center
- Velocity Clinical Research
- Icahn School of Medicine at Mount Sinai
- Velocity Clinical Research, Inc.
- Velocity Clinical Research
- Shelby Clinical Research, LLC
- The Brody School of Medicine at East Carolina University
- Monroe Biomedical Research
- M3 Wake Research, Inc.
- Carolina Research Center, Inc.
- Atrium Health Wake Forest Baptist
- The Lindner Research Center at The Christ Hospital
- STAT Research
- Velocity Clinical Research
- Frontier Clinical Research, LLC
- Velocity Clinical Research
- Clinovacare Medical Research Center
- WR-ClinSearch, LLC
- PharmaTex Research
- Central Texas Clinical Research
- St Hope Foundation, Inc.
- PanAmerican Clinical Research
- Velocity Clinical Research
- WR-Global Medical Research, LLC
- Baylor University Medical Center
- Premier Pulmonary Critical Care and Sleep Medicine
- Care United Research, LLC
- EmVenio Research
- Trio Clinical Trials, LLC.
- HDH Research Inc.
- Synergy Groups Medical LLC
- Diversified Medical Practices
- Next Level Urgent Care
- Synergy Groups Medical LLC
- The Crofoot Research Center, INC.
- Zion Research/Zion Urgent Care Clinic
- Milton Haber, MD
- SMS Clinical Research, LLC
- Synergy Groups Medical LLC
- Village Health Partners
- Village Health Partners
- North Texas Family Medicine
- Epic Medical Research, LLC
- STAAMP Research LLC
- VIP Trials
- ClinPoint Trials, LLC
- Tranquil Clinical Research
- Bountiful Internal Medicine
- Velocity Clinical Research, Salt Lake City
- Alliance for Multispecialty Research, LLC
- Frontier Clinical Research, LLC
- Hamilton Medical Research Group
- Kanagawa Himawari ClinicRecruiting
- Medical corporation Shirayurikai Swing Nozaki ClinicRecruiting
- Sato ClinicRecruiting
- Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kaiRecruiting
- Proyecto ACTU
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Obeldesivir
Obeldesivir Placebo
Participants will receive obeldesivir 350 mg twice daily for 5 days.
Participants will receive obeldesivir placebo twice daily for 5 days.