> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-obeldesivir-in-nonhospitalized-participants-with-f738cd89-adaa-417b-9952-09982ecab754 > Record changed: 2026-10-13 # Study of Obeldesivir in Nonhospitalized Participants With COVID-19 NCT05715528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) Participants 2,011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) Lead sponsor Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) Start date 2023-02-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) Number of sites 113 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Acronym** OAKTREE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Short title** Study of Obeldesivir in Nonhospitalized Participants With COVID-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Dates **Completion date** 2024-01-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **First posted** 2023-02-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Registry last updated** 2024-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Primary completion date** 2023-11-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Start date** 2023-02-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Size and sites **Actual participants** 2,011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Participants** 2,011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Number of sites** 113 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Lead sponsor** Gilead Sciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Identifiers **Registry ID** NCT05715528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **ClinicalTrials.gov ID** NCT05715528 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Participants, personnel directly involved in the conduct of study, and sponsor will not know the treatment participants received. **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Outcomes ### Primary outcomes 1. Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 Timeframe: First dose date up to 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. 2. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Timeframe: First dose date up to Day 5 plus 30 days 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. 3. Percentage of Participants Experiencing Laboratory Abnormalities Timeframe: First dose date up to Day 5 plus 30 days 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. 4. 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 Percentages were rounded off. ### Secondary outcomes 1. Time to COVID-19 Symptom Resolution by Day 29 Timeframe: Day 1 up to 29 COVID-19 symptom resolution was defined as all targeted symptoms scored as none for at least 48 consecutive hours. The first day of the 48 consecutive hours was considered the date of symptom resolution. The time to COVID-19 symptom resolution was the time (expressed as days) from the first dose date/time to the date/time of symptom resolution. KM estimates were used in the outcome measure analysis. 2. Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29 Timeframe: Up to Day 29 COVID-19 moderate symptom relapse was defined as having at least 1 symptom being moderate or severe OR at least 2 mild symptoms OR a hospitalization for COVID-19 or death, observed on a day during COVID-19 symptom relapse. Percentages were rounded off. 3. Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29 Timeframe: Up to Day 29 Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified. KM estimates were used in the outcome measure analysis. Percentages were rounded off. 4. Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29 Timeframe: Up to Day 29 COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19\. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration (if there was 1 day difference between the start date and end date) of hospital admission, and primary reason for hospitalization (including if the hospitalization was related to COVID-19) was to be recorded. Percentages were rounded off. 5. Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 Timeframe: Day 5 6. Time to Antigen Negativity Timeframe: Day 1 up to Day 29 Time to antigen negativity was defined (in days) as the number of days to the first date of 2 consecutive dates achieving a negative result. Antigen negativity was defined as 2 consecutive negative SARS-CoV-2 rapid antigen test (regardless if there was missing data in between), or negative test at last available sample for participants who completed or discontinued from the study after at least 1 positive antigen test. 7. Percentage of Participants With Viral Antigen Rebound Timeframe: Up to Day 29 Viral antigen rebound was defined as any positive SARS-CoV-2 rapid antigen test after antigen negativity. Percentages were rounded off. 8. 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 9. Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524 Timeframe: Day 5 AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady-state. 10. PK Parameter: Ctau of GS-441524 Timeframe: Day 1 and Day 5 Ctau is defined as the observed drug concentration at the end of the dosing interval. 11. PK Parameter: Cmax of GS-441524 Timeframe: Day 1 and Day 5 Cmax is defined as the maximum observed plasma concentration of drug. 12. Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29 Timeframe: Up to Day 29 Symptom relapse means at least 2 consecutive diary entries (regardless of missing data in between) where there was any symptom (regardless of severity) OR a hospitalization for COVID-19 or a death after short symptom recovery. Percentages were rounded off. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 12 Years **Maximum age** 64 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Sites - EmVenio ResearchAlabaster, United States - Institute for Liver Health dba Arizona Clinical TrialsChandler, United States - The Institute for Liver Health dba Arizona Liver HealthTucson, United States - Franco Felizarta, MDBakersfield, United States - Velocity Clinical Research, Banning (IP Delivery and Administering Location)Banning, United States - Benchmark ResearchColton, United States - Ascada ResearchFullerton, United States - Velocity Clinical ResearchLa Mesa, United States - IMAX Clinical Trials, LLCLa Palma, United States - Om Research LLCLancaster, United States - L.A. Universal Research Center, INC.Los Angeles, United States - Amicis Research CenterNorthridge, United States - Valley Clinical TrialsNorthridge, United States - Fomat Medical ResearchOxnard, United States - Paradigm Clinical ResearchRedding, United States - Zuckerberg San Francisco General HospitalSan Francisco, United States - Clearview Medical Research, LLCSanta Clarita, United States - EmVenio ResearchSanta Monica, United States - Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.Toluca Lake, United States - Georgetown University Medical CenterWashington D.C., United States - Encore Medical Research of Boynton Beach LLCBoynton Beach, United States - Palm Harbor Dermatology d/b/a TrueBlue Clinical ResearchBrandon, United States - Innovative Research of West Florida, IncClearwater, United States - Prestige Clinical Research Center IncCoral Gables, United States - Beautiful Minds Clinical Research CenterCutler Bay, United States And 88 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## References - PubMed 41475511 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41475511/) Related publication - PubMed 40675167 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40675167/) Related publication - Related resource (www.gileadclinicaltrials.com) Source: [www.gileadclinicaltrials.com](https://www.gileadclinicaltrials.com/study/?id=GS-US-611-6549) ### Other registry identifiers - jRCT2031230285 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05715528) ## Related records ### Drugs (1) - [Obeldesivir](https://trialight.com/data/asset/obeldesivir-8aa81b6c-8525-477b-a17f-5fce9e1a0e93.md) ### Lead sponsors (1) - [Gilead Sciences](https://trialight.com/data/company/gilead-sciences-dc2ce801-6c14-47ef-b8fc-217ce33be039.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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