Study Phase 2

A Two-Part Study With a Birth Cohort (Observational Stage) for Early Diagnosis of Respiratory Syncytial Virus (RSV), Followed by an Optional Phase 2a, Randomized, Double-blind, Placebo-controlled Study (Interventional Stage) to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 in Infants With Acute Respiratory Tract Infection Due to RSV

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT04068792
  • Notebook for Primary Citation Primary Citation Trial has yet to be published
  • Spreadsheet for Data Specification Data Specification Not Available

Trial Information

Generic NameRilematovirProduct NameN/ATherapeutic AreaAnti-Infectives for Systemic UseProduct ClassAntivirals for Systemic UsePharmacological SubgroupDirect Acting AntiviralsChemical SubgroupOther AntiviralsCondition StudiedRespiratory Syncytial Viruses
Sponsor Protocol Number53718678RSV2006Enrollment22Data PartnerJohnson & Johnson% Female31.8%Mean/Median Age (Years)3.6% White4.3%

Supporting Documentation

  • Collected Datasets Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

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