Zelicapavir versus placebo in adults at high risk for severe RSV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2b/3 trial evaluates the efficacy and safety of zelicapavir, an oral RSV replication inhibitor, versus placebo in non-hospitalized adults with RSV at high risk for severe outcomes. Participants must be 18 or older with COPD or CHF or be at least 75 years old, have RSV confirmed within 72 hours, and exhibit multiple recent respiratory symptoms. The study aims to determine if zelicapavir can reduce symptom burden and improve safety in this high-risk group. Enrollment is conducted at selected sites in Florida and South Carolina under Enanta Pharmaceuticals. The trial uses a randomized, controlled design with a contemporary comparator to establish benefit and safety signals.

Why it matters

Who can join: the full rules

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.

Where it's running

• C&A Clinical Trials Corp
  Cape Coral, Florida, United States Recruiting
• Continental Clinical Research, LLC
  Miami, Florida, United States Recruiting
• PanAmerican Clinical Research
  Bluffton, South Carolina, United States Recruiting
• PanAmerican Clinical Research - Brownville
  Brownsville, Texas, United States Recruiting

Study contacts

• Study coordinator: Chris Harris, MD
• Email: charris@enanta.com
• Phone: 617-607-0800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.