Study of Obeldesivir in Nonhospitalized Participants With COVID-19 (OAKTREE)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: COVID-19

Treatments: Drug: Obeldesivir Placebo; Drug: Obeldesivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05715528

jRCT2031230285 (Other Identifier)

GS-US-611-6549

Details and patient eligibility

About

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.

Enrollment: 2,011 patients

Sex: All

Ages: 12 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

2,011 participants in 2 patient groups, including a placebo group

Obeldesivir

Experimental group

Description:

Participants will receive obeldesivir 350 mg twice daily for 5 days.

Treatment:

Drug: Obeldesivir

Obeldesivir Placebo

Placebo Comparator group

Description:

Participants will receive obeldesivir placebo twice daily for 5 days.

Treatment:

Drug: Obeldesivir Placebo