Study of Obeldesivir in Nonhospitalized Participants With COVID-19 (OAKTREE)
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| ClinicalTrials.gov Identifier: NCT05715528 |
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Recruitment Status :
Recruiting
First Posted : February 8, 2023
Last Update Posted : May 11, 2023
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Obeldesivir Drug: Obeldesivir Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1900 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Participants, personnel directly involved in the conduct of study, and sponsor will not know the treatment participants received. |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 8, 2023 |
| Estimated Primary Completion Date : | June 2024 |
| Estimated Study Completion Date : | August 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
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Experimental: Obeldesivir
Participants will receive obeldesivir 350 mg twice daily for 5 days.
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Drug: Obeldesivir
Tablet administered orally without regard to food.
Other Name: GS-5245 |
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Placebo Comparator: Obeldesivir Placebo
Participants will receive obeldesivir placebo twice daily for 5 days.
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Drug: Obeldesivir Placebo
Tablet administered orally without regard to food. |
Primary Outcome Measures :
- Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 [ Time Frame: First dose date up to Day 29 ]
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to Day 5 plus 30 days ]
- Percentage of Participants Experiencing Laboratory Abnormalities [ Time Frame: 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 [ Time Frame: First dose date up to Day 5 plus 30 days ]
Secondary Outcome Measures :
- Time to COVID-19 Symptom Resolution by Day 29 [ Time Frame: Day 1 up to 29 ]
- Proportion of Participants with COVID-19 related Medically Attended Visits (MAVs) or All-cause Death by Day 29 [ Time Frame: Up to Day 29 ]
- Proportion of Participants with Moderate Relapse of COVID-19 Symptoms by Day 29 [ Time Frame: Up to Day 29 ]
- Proportion of Participants with COVID-19 related Hospitalization or All-cause Death by Day 29 [ Time Frame: Up to Day 29 ]
- Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 [ Time Frame: Baseline, Day 5 ]
- Time to Antigen Negativity [ Time Frame: Day 1 up to Day 29 ]
- Proportion of Participants with Viral Antigen Rebound [ Time Frame: First dose date up to Day 29 ]
- Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) [ Time Frame: Day 1, Day 3, and Day 5 ]
- Pharmacokinetic (PK) Parameter: AUCtau of GS-441524 [ Time Frame: Day 1, Day 3, and Day 5 ]AUCtau is defined as the area under the concentration versus time curve over the dosing interval
- PK Parameter: Ctau of GS-441524 [ Time Frame: Day 1, Day 3, and Day 5 ]Ctau is defined as the observed drug concentration at the end of the dosing interval
- PK Parameter: Cmax of GS-441524 [ Time Frame: Day 1, Day 3, and Day 5 ]Cmax is defined as the maximum observed plasma concentration of drug
- Proportion of Participants with Relapse of COVID-19 Symptoms by Day 29 [ Time Frame: Up to Day 29 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years to 64 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05715528
Contacts
| Contact: Gilead Clinical Study Information Center | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
Locations
Show 77 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Additional Information:
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT05715528 |
| Other Study ID Numbers: |
GS-US-611-6549 2023-503277-38 ( EudraCT Number ) |
| First Posted: | February 8, 2023 Key Record Dates |
| Last Update Posted: | May 11, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |