Health Condition 1: B974- Respiratory syncytial virus as thecause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Rilematovir: Participants of age group
birth at term after at least 37 weeks of gestation to less than 28 days age group 4 will receive rilematovir orally BID from Days 1 to Day 7 or Da
Sponsors
Janssen Research Development LLC
Eligibility
Inclusion criteria
Inclusion criteria: - The participant weighs within greater than or equal to 2.4 kilograms (kg) and less than or equal to 24.6 kg - Each participant’s parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative(s) has/have signed an informed consent form (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; with regards to the concomitant medication, the lifestyle consideration and study procedures and assessments to be performed by the parent(s)/caregiver(s) as well as those by the investigator/study site personnel - The participant has an acute respiratory illness with at least 1 of the signs/symptoms within 24 hours prior to start of screening and at screening, as evaluated by the investigator in Upper respiratory tract infection: nasal congestion or rhinorrhea; and Lower respiratory tract infection: increased respiratory effort (as evidenced by subcostal, intercostal or tracheosternal retractions, grunting, head bobbing, nasal flaring, or tachypnea), wheezing, cough, cyanosis, or apnea; and systemic/general: feeding difficulties (defined as less than 75 percent intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive) - The time of onset of RSV signs/symptoms to the anticipated time of randomization must be less than or equal to 3 days. Onset of signs/symptoms is defined as the time of the day (or part of the day if time of the day cannot be specified) the parent(s)/caregiver(s) became aware of the first sign and/or symptom consistent with respiratory or systemic/general manifestation of signs/symptoms of RSV infection. The time of sign/symptom onset has to be assessed as accurately as possible - Participants are otherwise healthy or have (a) risk factor(s) for severe RSV disease
Exclusion criteria
Exclusion criteria: - The participant has had either confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (test positive) during the four weeks prior to randomization, or close contact with a person with COVID-19 (test confirmed or suspected SARS CoV-2 infection) within 14 days prior to randomization - Confirmed QT interval corrected for heart rate according to Fridericia’s formula (QTcF) interval greater than ( >) 450 milliseconds (msec) per the machine read parameter result at screening. Presence of an abnormal QTcF interval should be confirmed by repeat electrocardiogram (ECG) recording during screening - Known personal or family history of Long QT Syndrome or sudden cardiac death - Presence of repetitive ventricular premature contractions ( >10/minutes [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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory Syncytial Virus (RSV)Recovery Scale (RRS) - The RRS is an ordinal scale assessing a participant’s clinical status.Timepoint: Upto day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s)Timepoint: Day 8;Change From Baseline in PRESORS ObsRO Signs/Symptoms Questionnaire Scores Over TimeTimepoint: Baseline Up to Day 21;Change From Baseline in RSV Viral Load Over Time Timepoint: Baseline to Day 21;Duration of Oxygen SupplementationTimepoint: Up to Day 35;Duration of Requiring ICU StayTimepoint: Up to Day 35;Duration of Supplemental Feeding/hydrationTimepoint: Up to Day 35;Number of Participants with Abnormalities in Clinical Laboratory Values (Hematology,Clinical chemistry, and routine urinalysis) Timepoint: Up to Day 35;Number of Participants with Abnormalities in Electrocardiograms (ECG) Timepoint: Up to Day 35;Number of Participants with Abnormalities in Vital Signs n(Temperature, pulse/heart rate, and peripheral capillary oxygen saturation [SpO2]) abnormalities will be assessed. Timepoint: Up to Day 35;Number of Participants with Adverse EventsTimepoint: Upto Day 35;Number of Participants with Antibiotic Treatment Episodes Timepoint: Up to Day 35;Number of Participants with Medical Encounters and Treatments Timepoint: Up to Day 35;Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline SequencesTimepoint: Up to Day 21;Number of Participants with Post-baseline RSV-Related Complications Timepoint: Up to Day 35;Number of Participants with Systemic or Inhaled Corticosteroids and Bronchodilators useTimepoint: Up to Day 35;Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube Timepoint: Up to Day 35;Percentage of Participants Requiring Intensive Care Unit (ICU) StayTimepoint: Up to Day 35;Percentage of Participants Requiring Oxygen SupplementationTimepoint: Up to Day 35;Percentage of Participants Requiring Rehospitalization for Respiratory/other ReasonsTimepoint: Up to Day 35;Percentage of Participants with Clinically Resolved RSV Disease as Asses | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Czech Republic, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Poland, Republic of Korea, Russian Federation, Spain, Sweden, Taiwan, Thailand, Turkey, United States of America
Contacts
Public ContactDr Sanish Davis
Johnson and Johnson Pvt. Ltd.
Outcome results
None listed