COVID-19Phase 3OAKTREENCT05715528
Study of Obeldesivir in Nonhospitalized Participants With COVID-19
A Phase 3 study testing Obeldesivir in people with COVID-19, run by Gilead Sciences at 113 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 64 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Obeldesivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,011 participants
- Where
- 113 sitesin 2 countries
- Study dates
- 8 Feb 2023to 23 Jan 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
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- Cough.
- Low energy or tiredness.
- Muscle or body aches.
- Headache.
- Chills or shivering.
- Feeling hot or feverish.
- Not currently hospitalized or requiring hospitalization.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
113 sites in 2 countries.
113 sites in 2 countries
United States108 sites
EmVenio Research
Alabaster, Alabama, 35007
EmVenio Research
Atlanta, Georgia, 30315
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Franco Felizarta, MD
Bakersfield, California, 93301
Velocity Clinical Research, Banning (IP Delivery and Administering Location)
Banning, California, 92220
St Hope Foundation, Inc.
Bellaire, Texas, 77401
Bountiful Internal Medicine
Bountiful, Utah, 84010
Encore Medical Research of Boynton Beach LLC
Boynton Beach, Florida, 33436
Palm Harbor Dermatology d/b/a TrueBlue Clinical Research
Brandon, Florida, 33511
PanAmerican Clinical Research
Brownsville, Texas, 78520
Institute for Liver Health dba Arizona Clinical Trials
Chandler, Arizona, 85224
Innovative Research of West Florida, Inc
Clearwater, Florida, 33756
Benchmark Research
Colton, California, 92324
Prestige Clinical Research Center Inc
Coral Gables, Florida, 33134
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157
Premier Pulmonary Critical Care and Sleep Medicine
Denison, Texas, 75020
Shelby Clinical Research, LLC
Denver, North Carolina, 28037
Vital Care Research
Doral, Florida, 33122
UHC Research, LLC
Doral, Florida, 33126
Covenant Pulmonary Critical Care Research Institute
East Point, Georgia, 30344
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308
EmVenio Research
Fort Worth, Texas, 26134
Ascada Research
Fullerton, California, 92835
The Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
Qway Research LLC
Hialeah, Florida, 33010
AGA Clinical Trials
Hialeah, Florida, 33012
Research in Miami
Hialeah, Florida, 33013
3Sync, LLC
Hialeah, Florida, 33016
Best Quality Research, Inc.
Hialeah, Florida, 33016
Doral Medical Research
Hialeah, Florida, 33016
Evolution Clinical Trials, INC
Hialeah Gardens, Florida, 33016
Innovative Health
Hollywood, Florida, 33024
Encore Medical Research, LLC
Hollywood, Florida, 33201
HDH Research Inc.
Houston, Texas, 77022
The Crofoot Research Center, INC.
Houston, Texas, 77098
Frontier Clinical Research, LLC
Kingwood, West Virginia, 26537
Velocity Clinical Research
La Mesa, California, 91942
IMAX Clinical Trials, LLC
La Palma, California, 90623
Velocity Clinical Research
Lafayette, Louisiana, 70508
Om Research LLC
Lancaster, California, 93534
Milton Haber, MD
Laredo, Texas, 78041
L.A. Universal Research Center, INC.
Los Angeles, California, 90057
SMS Clinical Research, LLC
Mesquite, Texas, 75149
Advance Clinical Research Group
Miami, Florida, 33122
Med-Care Research, Corp
Miami, Florida, 33125
Southern Clinical Research LLC
Miami, Florida, 33125
LCC Medical Research Institute, LLC
Miami, Florida, 33126
Universal Medical and Research Center, LLC.
Miami, Florida, 33126
CCM Clinical Research Group, LLC
Miami, Florida, 33133
Global Health Clinical Trials Corp
Miami, Florida, 33135
Retreat Medical Research
Miami, Florida, 33135
Verus Clinical Research, Corp
Miami, Florida, 33135
Clinical Trial Services, Corp
Miami, Florida, 33144
Continental Clinical Research
Miami, Florida, 33144
Dynamic Medical Research, LLC
Miami, Florida, 33144
Nuren Medical & Research Center
Miami, Florida, 33144
Advanced Care and Clinical Trials, LLC
Miami, Florida, 33155
Bioclinical Research Alliance Inc.
Miami, Florida, 33155
Cordova Research Institute, Inc
Miami, Florida, 33155
D&H National Research Centers, INC
Miami, Florida, 33155
Florida International Medical Research
Miami, Florida, 33155
Miami Clinical Research
Miami, Florida, 33155
Allied Biomedical Research Institute
Miami, Florida, 33166
Diverse Clinical Research, LLC
Miami, Florida, 33175
P&S Research, LLC.
Miami, Florida, 33175
ProLive Medical Research, Corp
Miami, Florida, 33175
Entrust Clinical Research
Miami, Florida, 33176
Links Clinical Trials LLC
Miami, Florida, 33176
Reed Medical Research Corp
Miami, Florida, 33176
MedBio Trials LLC
Miami, Florida, 33180
Clinical Site Partners, LLC dba Flourish Research
Miami, Florida, 33186
Phoenix Research Center, LLC
Miami, Florida, 33186
Essential Clinical Research
Miami Lakes, Florida, 33014
Palm Springs Community Health Center
Miami Lakes, Florida, 33014
Angels Clinical Research Institute
Miami Lakes, Florida, 33016
Quality Research of South Florida
Miami Lakes, Florida, 33016
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Oceanic Research Group
North Miami Beach, Florida, 33169
Amicis Research Center
Northridge, California, 91324
Valley Clinical Trials
Northridge, California, 91325
Fomat Medical Research
Oxnard, California, 93030
Castillo Torres, MD PA
Palm Springs, Florida, 33406
Family Clinical Trials, LLC
Pembroke Pines, Florida, 33026
Village Health Partners
Plano, Texas, 75024
Village Health Partners
Plano, Texas, 75025
North Texas Family Medicine
Plano, Texas, 75093
Epic Medical Research, LLC
Red Oak, Texas, 75154
Paradigm Clinical Research
Redding, California, 96001
STAAMP Research LLC
San Antonio, Texas, 78229
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Clearview Medical Research, LLC
Santa Clarita, California, 91351
EmVenio Research
Santa Monica, California, 90404
Carolina Research Center, Inc.
Shelby, North Carolina, 28150
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
USPA Advance Concept Medical Research Group, LLC
South Miami, Florida, 33143
Precision Clinical Research
Sunrise, Florida, 33351
Angels Clinical Research Institute
Tampa, Florida, 33614
Precision Research Center
Tampa, Florida, 33614
Santos Research Center, CORP
Tampa, Florida, 33615
Prime Global Research Inc
The Bronx, New York, 10456
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, 91602
The Institute for Liver Health dba Arizona Liver Health
Tucson, Arizona, 85712
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Tranquil Clinical Research
Webster, Texas, 77598
Clinovacare Medical Research Center
West Columbia, South Carolina, 29169
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088
Encore Medical Reseach of Weston, LLC
Weston, Florida, 33331
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
Japan5 sites
Kanagawa Himawari Clinic
Kawasaki-Shi, 216-0006
Medical corporation Shirayurikai Swing Nozaki Clinic
Musashino, 180-0022
Nishioka Hospital
Sapporo-Shi Toyohira-Ku, 062-0034
Sato Clinic
Shibuya-ku, 150-0013
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
Shinagawa-Ku, 140-8522
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Obeldesivir, Obeldesivir Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObeldesivirDrug
Also called GS-5245
Tablet administered orally without regard to food.
Obeldesivir PlaceboDrug
Tablet administered orally without regard to food.
| Study group | Role | What they receive |
|---|---|---|
| Obeldesivir | Experimental | Participants will receive obeldesivir 350 mg twice daily for 5 days. Receives: Drug: Obeldesivir |
| Obeldesivir Placebo | Placebo comparator | Participants will receive obeldesivir placebo twice daily for 5 days. Receives: Drug: Obeldesivir Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First dose date up to Day 5 plus 30 days
Secondary outcomes (12)
Time to COVID-19 Symptom Resolution by Day 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.
Measured: Day 1 up to 29
Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by 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.
Measured: Up to Day 29
Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by 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.
Measured: Up to Day 29
Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by 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.
Measured: Up to Day 29
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5
Measured: Day 5
Time to Antigen Negativity
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.
Measured: Day 1 up to Day 29
Percentage of Participants With Viral Antigen Rebound
Viral antigen rebound was defined as any positive SARS-CoV-2 rapid antigen test after antigen negativity.
Percentages were rounded off.
Measured: Up to Day 29
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)
Measured: Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hour
Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady-state.
Measured: Day 5
PK Parameter: Ctau of GS-441524
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: Day 1 and Day 5
PK Parameter: Cmax of GS-441524
Cmax is defined as the maximum observed plasma concentration of drug.
Measured: Day 1 and Day 5
Percentage of Participants With Relapse of COVID-19 Symptoms by 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.
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start8 Feb 2023
- Primary completion28 Nov 2023
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715528
- Sponsor's protocol ID
- GS-US-611-6549
- Other IDs
- jRCT2031230285
- Acronym
- OAKTREE
- Status last verified
- Dec 2024
- First submitted
- 3 Feb 2023
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez L, Hu Y, Li J, Han D, Peinovich N, Martinez C, Ho PY, Perry JK, Martin R, Ogbuagu O, Lichtman A, Hyland RH, Hedskog C. SARS-CoV-2 resistance analyses from the Phase 3 OAKTREE study of obeldesivir in low-risk nonhospitalized participants with COVID-19. Antiviral Res. 2026 Mar;247:106339. doi: 10.1016/j.antiviral.2025.106339. Epub 2025 Dec 29.
PubMed 41475511Ogbuagu O, Goldman JD, Gottlieb RL, Singh U, Shinkai M, Acloque G, Fusco DN, Gonzalez E, Kumar P, Luetkemeyer A, Lichtman A, Mozaffarian A, Koullias Y, Hyland RH, Llewellyn J, Osinusi A, Duff F, Humeniuk R, Caro L, Davies S, Rodriguez L, Hedskog C, Chen S, Etchevers K, Nadig P, Kohli A; OAKTREE Trial Investigators. Efficacy and safety of obeldesivir in low-risk, non-hospitalised patients with COVID-19 (OAKTREE): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Infect Dis. 2025 Dec;25(12):1282-1292. doi: 10.1016/S1473-3099(25)00238-5. Epub 2025 Jul 14.
PubMed 40675167