Enanta Pharmaceuticals, Inc
Zelicapavir is a novel orally administered non-fusion replication inhibitor of RSV that is being developed for the treatment of patients with RSV infection. This phase 2b/3 study will evaluate the efficacy and safety of zelicapavir compared with placebo in adults with RSV who are at high risk for severe disease. High-risk participants include those who are either ≥75 years of age or ≥18 years of age with COPD and/or CHF. Participants will be non-hospitalized adults who have up to 72 hours of respiratory tract infection symptoms and test positive for RSV.
Inclusion Criteria: * Age ≥75 years at the time of enrollment, or, age ≥18 at the time of enrollment and has at least one of the following conditions that predispose them to complications of RSV infection: 1. CHF 2. COPD * New onset or worsening of preexisting symptoms consistent with respiratory tract infection no more than 72 hours before administration of the first dose of study intervention: feeling feverish, headache, neck pain, fatigue, loss of appetite, interrupted sleep, body aches, sore throat, nasal congestion, cough, cough with phlegm, wheezing, or short of breath. * Reports a…
Zelicapavir 800mg, once daily for 7 days
Participants will take matching placebo, once daily for 7 days