Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

Gilead Sciences

Status and phase: Enrolling; Phase 2

Conditions: RSV Infection

Treatments: Drug: Obeldesivir; Drug: Obeldesivir Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06585150

GS-US-685-6819

Details and patient eligibility

About

The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it is in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers want to see if obeldesivir can help participants' symptoms get better faster.

The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV in nonhospitalized adult participants with acute RSV infection.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Exhibits at least 1 of the following risk factors for severe RSV disease:

  1. Age ≥ 60 years

  2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.

  3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months

  4. One or more of the following chronic lung diseases:

     • i) Bronchiectasis
     • ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
     • iii) Pulmonary hypertension

  5. Chronic cardiovascular disease exclusive of hypertension

• RSV infection confirmed ≤ 3 days before randomization

• New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity a screening, and onset ≤ 3 days before randomization.

• RSV vaccine status:

  • Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.

Key Exclusion Criteria:

• Currently requiring or expected to require hospitalization within 48 hours after randomization.
• Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
• Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization.
• Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization.
• Individuals with a history of cystic fibrosis.
• Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.
• Pregnant at screening.
• Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV < 28 days or < 5 half-lives, whichever is longer, before randomization.
• Received an investigational product < 28 days or < 5 half-lives, whichever is longer, 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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240 participants in 2 patient groups

Obeldesivir (ODV)

Experimental group

Description:

Participants will receive obeldesivir for 5 days

Treatment:

Drug: Obeldesivir

Placebo comparator: Obeldesivir Placebo

Experimental group

Description:

Participants will receive obeldesivir placebo for 5 days

Treatment:

Drug: Obeldesivir Placebo