Status:
TERMINATED
Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
Lead Sponsor:
Gilead Sciences
Conditions:
RSV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- Exhibits at least 1 of the following risk factors for severe RSV disease:
- Age ≥ 60 years
- Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
- Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
- One or more of the following chronic lung diseases:
- i) Bronchiectasis
- ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
- iii) Pulmonary hypertension
- 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
- 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.
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06585150
Start Date
October 14 2024
End Date
June 9 2025
Last Update
July 28 2025
Active Locations (121)
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1
Central Alabama Research
Birmingham, Alabama, United States, 35209
2
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
3
Lakeview Clinical Research, LLC
Guntersville, Alabama, United States, 35976
4
Headlands Research-Scottsdale
Scottsdale, Arizona, United States, 85260