Prestige Clinical Research Center Inc | Coral Gables, FL
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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
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Exhibits at least 1 of the following risk factors for severe RSV disease:
One or more of the following chronic lung diseases:
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:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups
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Central trial contact
Gilead Clinical Study Information Center
Data sourced from clinicaltrials.gov
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