A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

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 at least 2 of the following symptoms, one of which must be reported by the participant as at least moderate in severity using the RiiQ™: cough, cough with phlegm, wheezing, or short of breath.
Tested positive for RSV infection defined as a positive nucleic acid amplification test (PCR or other) or rapid-antigen viral detection test performed on a nasal swab specimen collected no more than 72 hours before administration of the first dose of study intervention.
A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug.
A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

Reported history of respiratory infection (other than RSV) within 7 days prior to signing the ICF.
Anticipated need for hospitalization within 24 hours of signing the ICF.
Receiving dialysis or have known severe renal impairment.
Reported history of chronic liver disease, including cirrhosis, autoimmune hepatitis, end stage liver disease, history of hepatocellular carcinoma, or decompensated liver failure.
Prior receipt of or waiting to receive a bone marrow, stem cell, or solid organ transplant. Currently taking, or has taken within 7 days prior to randomization, or is anticipated to receive during the study, systemic medications that are known to cause immunosuppression. Note: Chronic use of immunomodulators such as dupilumab and omalizumab is permitted.