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STATUS Will Be Recruiting

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

LAST UPDATED

September 05 2024

Clinicaltrials.gov ID

NCT06585150

OVERVIEW

A Phase 2 Randomized, Placebo-controlled Study of the Safety and Efficacy of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

PROTOCOL SUMMARY

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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

RSV Infection

Gender

N/A

Date

September 2024 - September 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Obeldesivir, Obeldesivir Placebo

Eligibility Information

Inclusion

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)
  • * 3) Asthma
  • * 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
  • * Acute RSV infection defined as RSV infection plus new onset or increased from baseline of symptoms, and at least 1 symptom of moderate severity within 3 days prior to randomization.
  • * RSV vaccine status:
  • * Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.
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Exclusion

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.
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