Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness (BIRCH)

Gilead Sciences

Status and phase: Terminated; Phase 3

Conditions: COVID-19

Treatments: Drug: Obeldesivir; Drug: Obeldesivir Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05603143

2022-002741-18 (EudraCT Number)

GS-US-611-6273

Details and patient eligibility

About

The goal of this clinical study is to test how well the study drug, obeldesivir (GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Willing and able to provide written informed consent.
• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by PCR or an approved alternative assay (eg. Rapid Antigen Test) ≤ 5 days before randomization. Serologic tests will not be accepted.
• Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization.
• Not currently hospitalized or requiring hospitalization.
• Presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease.

Key Exclusion Criteria:

• Anticipated use of COVID-19 therapies during the current COVID-19 illness.
• Received any direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
• Anticipated need for hospitalization < 48 hours after randomization.
• New oxygen requirement < 24 hours before randomization.
• Decompensated cirrhosis (Child-Pugh class B or C) or acute liver injury/failure.
• Undergoing dialysis, or history of moderate to severe renal impairment.
• Pregnant or breastfeeding (nursing).
• Unwilling to use protocol-mandated birth control.
• Received an approved, authorized or investigational COVID-19 vaccine (including booster dose) <120 days before randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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468 participants in 2 patient groups, including a placebo group

Obeldesivir

Experimental group

Description:

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

Treatment:

Drug: Obeldesivir

Placebo

Placebo Comparator group

Description:

Participants will receive placebo-to-match obeldesivir orally twice daily for 5 days.

Treatment:

Drug: Obeldesivir Placebo