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)

Janssen-Cilag International NV0 sites737 target enrollmentDecember 9, 2020

ConditionsRespiratory Syncytial Virus MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Respiratory Syncytial Virus
Sponsor: Janssen-Cilag International NV
Enrollment: 737
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 9, 2020

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV

Eligibility Criteria

Inclusion Criteria

•1\. The participant is a boy or girl \=28 days corrected for gestational age at birth to \=5 years old at the time of consent. Note: After this main study opens to neonate enrollment: in addition, a neonate (boy or girl) from birth at term (ie, after at least 37 weeks of gestation) to \<28 days at the time of consent.
•2\. The participant weighs within \=2\.4 kg and \=24\.6 kg.
•3\. Each participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an ICF indicating that (s)he:
•understands the purpose of, and procedures required for, the study,
•is willing for their child to participate in the study,
•is willing for their child to remain in the hospital until at least Day 2,
•is willing and able to adhere to the prohibitions and restrictions with regards to
•\- the concomitant medication,
•\- the lifestyle consideration,
•\- study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/study site personnel.

Exclusion Criteria

•1\. The participant had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study (eg, bidirectional Glenn procedure).
•2\. The participant has a neuromuscular disease that affects swallowing or the thoracic muscles, an evolving developmental disorder, major congenital anomalies or known cytogenetic or metabolic disorders other than the ones allowed above (see inclusion criterion \#8\).
•3\. The participant is considered by the investigator to be immunocompromised, whether due to underlying medical condition (eg, known human immunodeficiency virus \[HIV] infection, malignancy or genetic disorder other than immunoglobulin A deficiency) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of comorbidities, chemotherapy, radiation, stem cell or solid organ transplant).
•4\. The participant has a known or clinically suspected acute or chronically active hepatitis B or C infection (based on participant’s medical history or on participant’s examination) or history of active maternal hepatitis B or C infection around birth, unless the participant has tested negative for hepatitis B and C infection.
•5\. The participant has had either: a) Confirmed SARS\-CoV\-2 infection (test positive) during the four weeks prior to randomization, OR b) Close contact with a person with COVID\-19 (test confirmed or suspected SARS CoV\-2 infection) within 14 days prior to randomization.
•6\. The participant is being treated with extracorporeal membrane oxygenation.
•7\. Confirmed QTcF interval \>450 msec per the machine read parameter result at screening. Presence of an abnormal QTcF interval should be confirmed by repeat ECG recording during screening.
•8\. Presence of repetitive ventricular premature contractions (\>10/min), second or third degree heart block, or complete or incomplete left bundle branch block, or complete right bundle branch block per the machine read ECG result at screening. Presence of any of the above abnormalities should be confirmed by repeat ECG recording during screening.
•9\. Other clinically significant abnormal ECG findings not consistent with the present risk factor for severe RSV disease (if applicable) in the study population, as judged by the investigator based on the machine read ECG results at screening.