What this study is
Simplified from ClinicalTrials.govTesting a pill (zelicapavir) to treat RSV, a common respiratory virus that can cause serious lung illness, in non-hospitalized adults at high risk for severe disease: those 75 or older, or 18 or older with COPD or heart failure. Participants must have had RSV symptoms for up to 72 hours and test positive for RSV.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- zelicapavir
Intervention · DRUG
Zelicapavir 800mg, once daily for 7 days
- Placebo
Intervention · DRUG
Participants will take matching placebo, once daily for 7 days
Study details
- Official title
- 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
- Sponsor
- Enanta Pharmaceuticals, Inc
- Conditions
- RSV
- Enrolling
- 860 people
- Starts
- 2026-10-19
- Est. completion
- 2029-07
- Design
- Triple-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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:; CHF; 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.
You can't join if
- 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 immunosuppressionExcept: Note: Chronic use of immunomodulators such as dupilumab and omalizumab is permitted.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openC&A Clinical Trials Corp
Cape Coral, Florida, United States
RecruitingContinental Clinical Research, LLC
Miami, Florida, United States
RecruitingPanAmerican Clinical Research
Bluffton, South Carolina, United States
RecruitingPanAmerican Clinical Research - Brownville
Brownsville, Texas, United States
Recruiting
Study team
Sponsor
Enanta Pharmaceuticals, Inc
Study ID EDP 938-105
Study director
Enanta Pharmaceuticals, Inc
Enanta Pharmaceuticals, Inc
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.