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Rilematovir in Infants and Children Hospitalized With Acute Respiratory Tract Infection Due to RSV


Title A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir in Infants and Children (≥28 Days to ≤5 Years of Age) and Subsequently in Neonates (<28 Days of Age), Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
Therapeutic Area Respiratory Syncytial Virus Infections (Tufts Children's)
Principal Investigator Daniel Rauch, MD
Min Age 0 Years
Max Age 5 Years
Gender All
Contact Vidya Iyer, MD, CCRA / Bipin Malla, MBBS, CCRA / Christhian Cano-Guerra, MD
617-636-0186 / 1044 / 8144
viyer1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04583280

Overview

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, interventional study in infants and children (≥28 days to ≤5 years of age) and subsequently in neonates (<28 days of age), hospitalized (refers to having planned at least 24 hours with an overnight stay in the hospital) with RSV infection. Rilematovir is an investigational, potent small-molecule RSV-specific fusion inhibitor belonging to the indole chemical class. Rilematovir targets the RSV F protein and prevents the conformational changes of the F protein required for fusion of the viral envelope with the host cell membrane and for cell-to-cell fusion, thereby inhibiting viral replication and syncytia formation. Study participants with signs/symptoms of an acute respiratory illness supporting a diagnosis of RSV infection will be identified and tested for RSV infection when they are hospitalized or present to the ER/clinic and are expected to be hospitalized. Participants should only be screened if they are expected to be randomized within ≤3 days of RSV sign/symptom onset.

Study Details

Inclusion Criteria

  • Participant has been diagnosed with RSV infection using PCR and is hospitalized
  • Participant has an acute respiratory illness with at least 1 of the signs/symptoms listed within 24 hours prior to start screening
  • Time of onset of RSV sign/symptoms to the anticipated time of randomization must be less or equal than 3 days

Exclusion Criteria

  • Participant had a mjor surgery within 28 days
  • Participant has a neuromuscular disease
  • Participant is considered by the investigator to be immunocompromised

Study Requirements

Participant would be invoked on the trial for at least 35 days (+/- 3 days), since enrollment and administration of the study drug. Administration of the study drug would start during the hospitalization and will be taken for 7 days or 14 doses. Patient could be discharged home in the meantime. Subject’s parents will be asked to complete signs/symptoms and caregiver impact questionnaires in a mobile device provided by sponsor while on the study. On site visits, home health care visits or telemedicine visits with home health care for safety and efficacy assessments visits would be completed during days 3, 5, 8, 14, 21 and 35 if the patient is discharge home.