Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSV
- Conditions
- Respiratory Syncytial VirusMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-002023-11-HU
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 737
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.
4. The participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)- or other molecular-based diagnostic assay. Note: If a participant had a positive RSV test result using a molecular-based diagnostic assay from another study for which (s)he was otherwise ineligible or from a SOC molecular-based diagnostic test within 24 hours prior to start of screening and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for determination of eligibility.
5. The participant has an acute respiratory illness with at least 1 of the signs/symptoms listed in each of the following categories within 24 hours prior to start of screening and at screening, as evaluated by the investigator:
• 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 <75% intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive).
*Cough cannot be the only LRTI sign/symptom present, ie, another LRTI sign/symptom needs to be present for eligibility.
6. The time of onset of RSV signs/symptoms to the anticipated time of randomization must be =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.
7. The participant is hospitalized or presented to the ER/clinic and expected to be hospitalized. Note: Hospitalized refers to having at least 24 hours with an overnight stay in the hospital.
8. Participants are otherwise healthy or have (a) risk factor(s) for severe RSV disease. Participants who are immunocompromised are excluded.
9. The participant must have been assessed per local public health practice and considered not to have SARS-CoV-2 infection during this respiratory infection.
Are the trial subjects under 18? yes
Number of subje
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method