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
A Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Zelicapavir for Respiratory Syncytial Virus Infection in Adults Who Are at High Risk for Severe Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 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. Exclusion Criteria: * 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.
Study sites (4)
FL
- C&A Clinical Trials Corp · Cape Coral, FL 33990More trials in Cape Coral
- Continental Clinical Research, LLC · Miami, FL 33144More trials in Miami
SC
- PanAmerican Clinical Research · Bluffton, SC 29910More trials in Bluffton
TX
- PanAmerican Clinical Research - Brownville · Brownsville, TX 78520More trials in Brownsville