Study Phase 3

A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV) (DAISY)

  • PDF icon for CSR Summary CSR Summary Not Yet Available
  • Globe symbol for NCT Number NCT04583280
  • Notebook for Primary Citation Primary Citation Trial has yet to be published
  • Spreadsheet for Data Specification Data Specification Not Yet 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 Number53718678RSV3001Enrollment28Data PartnerJohnson & Johnson% Female35.7%Mean/Median Age (Years)15.9% White71.4%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available
Additional Information

As the study was terminated early, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety, and selected PK and efficacy parameters only.

Disclaimer

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