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Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Eligibility criteria shortened, about 1 wordv2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this real-world, prospective observational study is to evaluate the clinical effectiveness of zamerovimab and mazorelvimab injection (a human rabies monoclonal antibody cocktail) administered in combination with a standard rabies vaccine for post-exposure prophylaxis (PEP) in individuals with WHO Grade III rabies exposure in Nanyang City, China. 1. The study primarily aims to assess: 2. The 3-month rabies-free survival rate following PEP initiation. 3. The 1-year long-term rabies-free survival rate. The rabies virus (RABV) carrying rate and genomic epidemiology among offending dogs involved in single-dog multiple-bite incidents. Eligible participants aged 18 years or older who have sustained a Grade III exposure from a tracked multi-person canine attack event, and have completed wound debridement and initial passive/active immunization within 24 hours prior to screening, will be followed for up to 1 year via telephone or clinic visits to monitor clinical survival.
Trial Details
NCT Number NCT07624461
Lead Sponsor Synermore Biologics (Suzhou) Co., Ltd.
Conditions
(from sponsor)
Rabies Post-exposure Prophylaxis, Rabies
Related terms Rabies
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov