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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)

Primary Purpose

Respiratory Tract Infections

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rilematovir
Rilematovir X mg/kg
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Tract Infections

Eligibility Criteria

1 Day - 5 Years (Child)All SexesDoes not accept healthy volunteers

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 <75 percent [%] intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive). Cough or wheezing cannot be the only LRTI sign/symptom present, that is, at least one other LRTI sign/symptom needs to be present for eligibility
  • 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:

  • 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

Sites / Locations

  • Arnold Palmer Hospital For Children
  • University of Mississippi Medical Center
  • Jacobi Medical Center
  • Le Bonheur Children's Hospital
  • MultiCare Health Systems for Research and Innovation
  • Hospital Interzonal General de Agudos Dr. Jose Penna
  • Hospital Italiano Regional Del Sur
  • Hospital General de Niños Pedro de Elizalde
  • Hospital Universitario Austral
  • Instituto Médico Río Cuarto
  • Clinica Mayo de UMCB
  • Hospital del Niño Jesús
  • ULB Hôpital Erasme
  • AZ Sint-Jan Brugge-Oostende AV
  • UZ Brussel
  • Cliniques Universitaires Saint-Luc
  • UZ Leuven
  • Santa Casa de Misericordia de Belo Horizonte
  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
  • Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
  • Nucleo de Pesquisa do Hospital Pequeno Princípe
  • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
  • Associação Hospitalar Moinhos de Vento
  • Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
  • Fundacao Jose Luiz Egydio Setubal
  • Santa Casa de Misericórdia de Votuporanga
  • UMHAT 'Sveti Georgi'-Plovdiv
  • UMHAT 'Kanev' EAD
  • Acibadem City Clinic Tokuda Hospital
  • UMHAT 'Aleksandrovska' EAD
  • SHATCD 'Prof. Ivan Mitev' EAD
  • Capital Institute of Pediatrics
  • Beijing Children's Hospital, Capital Medical University
  • Peking University Third Hospital
  • West China Second University Hospital, Sichuan University
  • Guangzhou Women And Children's Medical Center
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Kralovske Vinohrady
  • Thomayerova nemocnice
  • Tallinn Children's Hospital
  • Tartu University Hospital
  • Universitätsklinik Freiburg
  • HELIOS Klinikum Wuppertal GmbH
  • Universitätsklinikum Würzburg
  • Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika
  • Bethesda Gyermekkórház
  • Debreceni Egyetem Klinikai Kozpont
  • Petz Aladar Megyei Oktato Korhaz
  • Bacs-kiskun Megyei Korhaz
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Szegedi Tudomanyegyetem
  • Csolnoky Ferenc Korhaz
  • Soroka University Medical Center
  • Ruth Rappaport Children's Hospital, Rambam Health Care Campus
  • Schneider Children's Medical Center
  • Pediatrics B, Safra Children's Hospital, Tel Hashomer
  • Sourasky MC
  • A.O.U Sant'Orsola-Malpighi
  • Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Department of Pediatrics University of Pavia, Policlinico San Matteo
  • Ospedale degli Infermi
  • Fukui Prefectural Hospital
  • Fukuyama City Hospital
  • Kagoshima Children's Hospital
  • Teine Keijinkai Hospital
  • National Hospital Organization Kanazawa Medical Center
  • Japan Community Health care Organization Kyushu Hospital
  • Kobe City Medical Center General Hospital
  • Kochi Health Sciences Center
  • Maebashi Red Cross Hospital
  • Daido Hospital
  • National Hospital Organization Niigata National Hospital
  • National Hospital Organization Beppu Medical Center
  • National Hospital Organization Saitama National Hospital
  • National Hospital Organization Ureshino Medical Center
  • Yamanashi Prefectural Central Hospital
  • Kyungpook National University Hospital
  • CHA Bundang Medical Center, CHA University
  • Korea Institute of Radiological and Medical Sciences
  • Nowon Eulji Medical Center, Eulji University
  • Kangbuk Samsung Hospital
  • Samsung Medical Center
  • Inje University Sanggye Paik Hospital
  • Children's Clinical University Hospital
  • Hospital Selayang
  • Hospital Bintulu
  • Hospital Miri
  • Hospital Sibu
  • Hospital Taiping
  • Instituto Nacional de Pediatría
  • Hospital Infantil de Mexico Federico Gomez
  • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
  • Centro Medico Zambrano Hellion
  • Cevaxin Avenida Mexico
  • Krakowski Szpital Specjalistyczny im Jana Pawla II
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • Uniwersytecki Szpital Dzieciecy w Lublinie
  • Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego
  • DFNsP Banska Bystrica
  • Pediatric Pulmonology Clinic, University Hospital Bratislava
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Univ. de Cruces
  • Hosp. Reina Sofia
  • Hosp. Univ. de Getafe
  • Hosp. Univ. Fund. Jimenez Diaz
  • Hosp. Univ. La Paz
  • Hosp. Univ. 12 De Octubre
  • Hosp. Univ. Hm Monteprincipe
  • Hosp. Univ. Severo Ochoa
  • Hosp. Univ. Pta. de Hierro Majadahonda
  • Hosp. Puerta Del Sur
  • Complejo Hosp. de Navarra
  • Hosp. Quiron Madrid Pozuelo
  • Hosp. Clinico Univ. de Santiago
  • Astrid Lindgrens barnsjukhus Solna
  • Hsinchu MacKay Memorial Hospital
  • Taipei Medical University Shuang Ho Hospital
  • National Taiwan University Hospital
  • Mackay Memorial Hospital
  • Chang Gung Medical Foundation
  • Tropical Medicine Hospital, Mahidol University
  • Siriraj Hospital Mahidol University
  • Maharaj Nakorn Chiangmai Hospital
  • Srinagarind Hospital
  • Bamrasnaradura Infectious Disease Institute
  • Faculty of Medicine Chulalongkorn University
  • Cukurova University Medical Faculty Balcali Hospital
  • Hacettepe University Medical Faculty
  • Gazi University Medical Faculty
  • Istanbul University Istanbul Medical Faculty
  • Ege University Medical Faculty
  • Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital
  • Karadeniz Teknik University Medical Faculty
  • MNPE City Children's Clinical Hospital № 6 of Dnipro City Council
  • ME 'Dnipropetrovsk Regional Children's Clinical Hospital of Dnipropetrovsk Regional Council'
  • Kharkiv National Medical University on based CHPI Kharkiv Municipal Clinical Children's Hospital 16
  • MUNICIPAL NON-PROFIT ENTERPRISE 'Kryvyi Rih CITY HOSPITAL №16' Kryvyi Rih CITY COUNCIL
  • Odessa Regional Child Hospital
  • SSU Division MU Ch of pediatrics of PGE with propedeutic pediatrics and children infections course
  • Sumy Regional Childrens Clinical Hospital
  • Municipal institution 'Vinnytsia Regional Clinical Children's Infectious Diseases Hospital'
  • MNPE Zaporizhzhya Regional Clinical Children's Hospital of Zaporizhzhya Regional Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rilematovir

Placebo

Arm Description

Participants will receive rilematovir orally based on body weight and age group.

Participants will receive matching placebo of rilematovir based on body weight and age group.

Outcomes

Primary Outcome Measures

Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category
RRS was an ordinal scale to assess a participant's clinical status. The RRS provided 7 mutually exclusive categories ordered from best (1) to worst (7) where 1 =home without signs/symptoms, 2 =home with sign/symptoms, 3 =ward without supplemental oxygen (O2) or feeding/hydration, 4 =ward with supplemental or feeding/hydration, 5 =intensive care unit (ICU) without mechanical ventilation (included both invasive and non-invasive mechanical ventilation), 6 =required mechanical ventilation and 7=worst (death). Higher category indicates worse condition. With or without signs/symptoms was defined as the key RSV signs/symptoms (breathing problems, retractions, tachypnea, cough, wheezing/breathing sounds, and tachycardia) resolved (absent or mild) or not resolved assessed by parent/caregiver.

Secondary Outcome Measures

Percentage of Participants Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms at Day 8
Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had Key RSV signs/symptoms resolved to absent or mild as per ClinRO signs/symptoms. Clinically resolved Key RSV signs/symptoms were assessed based on clinician's observations as resolved if participant had no retractions, tachypnea, tachycardia, breathing problems (nasal flaring, head bobbing, grunting); cough (resolved if little or no coughing or occasional strong cough or sometimes productive) and wheezing (resolved if no wheezing or terminal expiratory wheezing or only with stethoscope).
Time From First Study Dose to Resolution of Key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours
Time (in hours) from first dose of study intervention to first resolution of key RSV signs/symptoms was evaluated based on ObsRO assessment after free of supplementation (O2/feeding/hydration) for at least 24 hours. Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had key RSV signs/symptoms resolved to absent or mild as per ObsRO signs/symptoms. Resolution of key signs/symptoms assessment was based on observations of child's parent/caregiver as resolved if no retractions, tachypnea, tachycardia, breathing problems (gasping for air nostrils, flaring when breathing, head bobbed back and forth when breathing), no breathing sound; cough (no coughing, little coughing without problems). Kaplan-Meier method was used for estimation.
Number of Participants With Post-baseline RSV-related Complications
RSV related complications included respiratory complications (respiratory failure, apnoeic attacks, bronchiolitis, bronchial obstruction, pneumonia and asthmatic crisis), infectious complications (otitis media, bacterial respiratory tract infections and sepsis), cardiovascular complications (arrhythmia, cardiogenic shock, hemodynamic instability, congestive cardiac failure), acid-base or electrolyte complications (metabolic acidosis, metabolic alkalosis, hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoglycemia and hyperglycemia). Participants were counted only once, regardless of the number of complications they actually experienced.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE with an onset after the initiation study drug (Day 1) up to end of study (Day 35). AEs included both serious and non-serious AEs.
Number of Participants With Abnormalities in Clinical Laboratory Values
Number of participants with abnormally low (AL) and abnormally high (AH) values of bicarbonate, direct bilirubin, urea nitrogen, basophils, eosinophils, erythrocyte (Ery). mean corpuscular hemoglobin (HGB) concentration (conc), Ery. mean corpuscular hemoglobin, erythrocytes, leukocytes, lymphocytes, monocytes, neutrophils and reticulocytes were reported based on the investigator's discretion.
Number of Participants With Abnormalities in Electrocardiograms (ECGs)
Number of participants with abnormally low and abnormally high values of ECG parameters (PR interval and RR interval) as assessed based on the investigator's discretion were reported.
Number of Participants With Abnormalities in Vital Signs
Number of participants with abnormally low and abnormally high values of vital signs from baseline were assessed based on investigator's discretion. Vital signs included systolic blood pressure (SBP) (millimeter of mercury [mmHg]), diastolic blood pressure (DBP) (mmHg), pulse rate (beats per minute), respiratory rate (breaths per minute), temperature (degree Celsius) and oxygen saturation (in percentage).
Percentage of Participants Requiring Intensive Care Unit (ICU) Stay After First Dose of Rilematovir
Percentage of participants requiring ICU stay was analyzed and reported.
Duration of ICU Stay
Duration (in hours) of ICU stay was defined as total number of hours a participant experienced an ICU stay from first dose of rilematovir until study termination, calculated as the sum of all separate records of ICU stay.
Percentage of Participants Requiring Re-hospitalization for Respiratory/Other Reasons
Percentage of participants requiring re-hospitalization (participants re-hospitalized [ward or ICU] after been discharged from hospital) for respiratory/other reasons were reported.
Percentage of Participants Requiring Oxygen Supplementation After First Dose of Rilematovir
Percentage of participants requiring any type of oxygen supplementation (invasive mechanical ventilation, non-invasive mechanical ventilation and non-invasive non-mechanical ventilation) were reported.
Duration of Oxygen Supplementation
Duration (in hours) of oxygen supplementation was defined as total number of hours a participant used supplemental oxygen from either prior to first dose and/or after first dose of drug until study termination, calculated as the sum of all separate records of supplementation.
Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube After First Dose of Rilematovir
Percentage of participants requiring any type of hydration and/or feeding by intravenous (IV) administration or nasogastric tube or percutaneous endoscopic gastrostomy was reported.
Duration of Supplemental Feeding/Hydration
Duration (in hours) of supplemental feeding/hydration was defined as total number of hours a participant was administered feeding/hydration supplementation from either prior to first dose and/or after first dose of drug until study termination, calculated as the sum all separate records of supplementation use per participant.
Number of Participants With Medical Encounters and Treatments
Medical resource utilization was assessed by medical care encounters and treatments. Medical encounters and treatments included physician or emergency room visits, tests and procedures, and medications, surgeries and other selected procedures, inpatient and outpatient.
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21
Antiviral activity was determined based on measurements of RSV viral load which was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the mid-turbinate (MT) nasal swab specimens.
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21
Antiviral activity was determined based on measurements of RSV viral load which was measured by qRT-PCR in the MT nasal swab specimens.
Percentage of Participants With Undetectable RSV Viral Load
Percentage of participants with undetectable RSV viral load was analyzed.
Plasma Concentrations of Rilematovir
Plasma concentrations of rilematovir were assessed. Participant wise data were reported for this outcome measure.
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s)
Acceptability and palatability were assessed by clinician electronic clinical outcome assessment (eCOA) questionnaire which consisted of 7 questions, 1- child took medicine easily, 2- disgusted expressions after tasting medicine, 3- cried after tasting medicine, 4- would not open mouth or turned head away to avoid medicine, 5- spit out or coughed out medicine, 6- gagged, 7- vomited (within 2 minutes of swallowing medicine).

Full Information

First Posted
October 9, 2020
Last Updated
March 16, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04583280
Brief Title
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
Acronym
DAISY
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Janssen made the strategic decision to discontinue the DAISY study. This decision is not based on any safety concerns.
Study Start Date
September 6, 2021 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
Detailed Description
Respiratory syncytial virus (RSV), a negative-stranded ribonucleic acid (RNA) virus belonging to the Pneumoviridae family, is considered the most important cause of acute lower respiratory tract infection (LRTI) in infants and young children. In most patients, RSV results in upper respiratory tract infection (URTI) eliciting "common cold"-like symptoms, which might last up to 2 weeks, and are usually self-limiting. RSV-related LRTI is a major cause of hospital admissions and death in young children worldwide. Rilematovir is an investigational, small molecule, RSV fusion inhibitor. This study aims to evaluate the efficacy and safety of rilematovir in hospitalized infants and children (greater than or equal to [>=] 28 days to less than or equal to [<=] 5 years) and, subsequent to completion of the neonatal substudy, in hospitalized neonates (born at term, less than [<] 28 days of age) with RSV infection. The study will include a Screening Period, a Treatment Period, and a Follow-up Period. The total study duration for each participant will be approximately 36 days (Screening included). The efficacy assessments include evaluation under the RRS and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rilematovir
Arm Type
Experimental
Arm Description
Participants will receive rilematovir orally based on body weight and age group.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive matching placebo of rilematovir based on body weight and age group.
Intervention Type
Drug
Intervention Name(s)
Rilematovir
Other Intervention Name(s)
JNJ-53718678
Intervention Description
Participants of age group greater than or equal to (>=) 28 days to less than (<) 3 months (age group 1) or >= 3 months to < 6 months (age group 2) or >= 6 months to less than or equal to (<=) 5 years (age group 3) will receive rilematovir orally twice a day (BID) from Days 1 to Day 7 or Day 8.
Intervention Type
Drug
Intervention Name(s)
Rilematovir X mg/kg
Other Intervention Name(s)
JNJ-53718678
Intervention Description
Participants of age group birth at term (after at least 37 weeks of gestation) to < 28 days (age group 4) will receive rilematovir orally BID from Days 1 to Day 7 or Day 8. The dose is dependent on outcome of the substudy in neonates and following independent data monitoring (IDMC) review and recommendation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participant of age group 1, 2, 3 and 4 will receive matching placebo of rilematovir BID from Days 1 to Day 7 or Day 8 as per assigned age group.
Primary Outcome Measure Information:
Title
Percentage of Participants by Respiratory Syncytial Virus (RSV) Recovery Scale (RRS) Category
Description
RRS was an ordinal scale to assess a participant's clinical status. The RRS provided 7 mutually exclusive categories ordered from best (1) to worst (7) where 1 =home without signs/symptoms, 2 =home with sign/symptoms, 3 =ward without supplemental oxygen (O2) or feeding/hydration, 4 =ward with supplemental or feeding/hydration, 5 =intensive care unit (ICU) without mechanical ventilation (included both invasive and non-invasive mechanical ventilation), 6 =required mechanical ventilation and 7=worst (death). Higher category indicates worse condition. With or without signs/symptoms was defined as the key RSV signs/symptoms (breathing problems, retractions, tachypnea, cough, wheezing/breathing sounds, and tachycardia) resolved (absent or mild) or not resolved assessed by parent/caregiver.
Time Frame
Baseline to Day 8
Secondary Outcome Measure Information:
Title
Percentage of Participants Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms at Day 8
Description
Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had Key RSV signs/symptoms resolved to absent or mild as per ClinRO signs/symptoms. Clinically resolved Key RSV signs/symptoms were assessed based on clinician's observations as resolved if participant had no retractions, tachypnea, tachycardia, breathing problems (nasal flaring, head bobbing, grunting); cough (resolved if little or no coughing or occasional strong cough or sometimes productive) and wheezing (resolved if no wheezing or terminal expiratory wheezing or only with stethoscope).
Time Frame
Day 8
Title
Time From First Study Dose to Resolution of Key RSV Signs/Symptoms Based on Observer Reported Outcome (ObsRO) After Free of Supplementation (Oxygen/Feeding/Hydration) for at Least 24 Hours
Description
Time (in hours) from first dose of study intervention to first resolution of key RSV signs/symptoms was evaluated based on ObsRO assessment after free of supplementation (O2/feeding/hydration) for at least 24 hours. Clinically resolved was defined as participant required no oxygen supplementation, no supplemental feeding/hydration, no need for ICU and had key RSV signs/symptoms resolved to absent or mild as per ObsRO signs/symptoms. Resolution of key signs/symptoms assessment was based on observations of child's parent/caregiver as resolved if no retractions, tachypnea, tachycardia, breathing problems (gasping for air nostrils, flaring when breathing, head bobbed back and forth when breathing), no breathing sound; cough (no coughing, little coughing without problems). Kaplan-Meier method was used for estimation.
Time Frame
Up to Day 21
Title
Number of Participants With Post-baseline RSV-related Complications
Description
RSV related complications included respiratory complications (respiratory failure, apnoeic attacks, bronchiolitis, bronchial obstruction, pneumonia and asthmatic crisis), infectious complications (otitis media, bacterial respiratory tract infections and sepsis), cardiovascular complications (arrhythmia, cardiogenic shock, hemodynamic instability, congestive cardiac failure), acid-base or electrolyte complications (metabolic acidosis, metabolic alkalosis, hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoglycemia and hyperglycemia). Participants were counted only once, regardless of the number of complications they actually experienced.
Time Frame
Up to Day 35
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE with an onset after the initiation study drug (Day 1) up to end of study (Day 35). AEs included both serious and non-serious AEs.
Time Frame
Day 1 up to Day 35
Title
Number of Participants With Abnormalities in Clinical Laboratory Values
Description
Number of participants with abnormally low (AL) and abnormally high (AH) values of bicarbonate, direct bilirubin, urea nitrogen, basophils, eosinophils, erythrocyte (Ery). mean corpuscular hemoglobin (HGB) concentration (conc), Ery. mean corpuscular hemoglobin, erythrocytes, leukocytes, lymphocytes, monocytes, neutrophils and reticulocytes were reported based on the investigator's discretion.
Time Frame
Up to Day 35
Title
Number of Participants With Abnormalities in Electrocardiograms (ECGs)
Description
Number of participants with abnormally low and abnormally high values of ECG parameters (PR interval and RR interval) as assessed based on the investigator's discretion were reported.
Time Frame
Up to Day 35
Title
Number of Participants With Abnormalities in Vital Signs
Description
Number of participants with abnormally low and abnormally high values of vital signs from baseline were assessed based on investigator's discretion. Vital signs included systolic blood pressure (SBP) (millimeter of mercury [mmHg]), diastolic blood pressure (DBP) (mmHg), pulse rate (beats per minute), respiratory rate (breaths per minute), temperature (degree Celsius) and oxygen saturation (in percentage).
Time Frame
Up to Day 35
Title
Percentage of Participants Requiring Intensive Care Unit (ICU) Stay After First Dose of Rilematovir
Description
Percentage of participants requiring ICU stay was analyzed and reported.
Time Frame
Up to Day 35
Title
Duration of ICU Stay
Description
Duration (in hours) of ICU stay was defined as total number of hours a participant experienced an ICU stay from first dose of rilematovir until study termination, calculated as the sum of all separate records of ICU stay.
Time Frame
Up to Day 35
Title
Percentage of Participants Requiring Re-hospitalization for Respiratory/Other Reasons
Description
Percentage of participants requiring re-hospitalization (participants re-hospitalized [ward or ICU] after been discharged from hospital) for respiratory/other reasons were reported.
Time Frame
Up to Day 35
Title
Percentage of Participants Requiring Oxygen Supplementation After First Dose of Rilematovir
Description
Percentage of participants requiring any type of oxygen supplementation (invasive mechanical ventilation, non-invasive mechanical ventilation and non-invasive non-mechanical ventilation) were reported.
Time Frame
Up to Day 35
Title
Duration of Oxygen Supplementation
Description
Duration (in hours) of oxygen supplementation was defined as total number of hours a participant used supplemental oxygen from either prior to first dose and/or after first dose of drug until study termination, calculated as the sum of all separate records of supplementation.
Time Frame
Up to Day 35
Title
Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube After First Dose of Rilematovir
Description
Percentage of participants requiring any type of hydration and/or feeding by intravenous (IV) administration or nasogastric tube or percutaneous endoscopic gastrostomy was reported.
Time Frame
Up to Day 35
Title
Duration of Supplemental Feeding/Hydration
Description
Duration (in hours) of supplemental feeding/hydration was defined as total number of hours a participant was administered feeding/hydration supplementation from either prior to first dose and/or after first dose of drug until study termination, calculated as the sum all separate records of supplementation use per participant.
Time Frame
Up to Day 35
Title
Number of Participants With Medical Encounters and Treatments
Description
Medical resource utilization was assessed by medical care encounters and treatments. Medical encounters and treatments included physician or emergency room visits, tests and procedures, and medications, surgeries and other selected procedures, inpatient and outpatient.
Time Frame
Up to Day 35
Title
RSV Viral Load at Baseline, Days 2, 3, 5, 8, 14 and 21
Description
Antiviral activity was determined based on measurements of RSV viral load which was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the mid-turbinate (MT) nasal swab specimens.
Time Frame
Baseline, Days 2, 3, 5, 8, 14 and 21
Title
Change From Baseline in RSV Viral Load at Days 2, 3, 5, 8, 14 and 21
Description
Antiviral activity was determined based on measurements of RSV viral load which was measured by qRT-PCR in the MT nasal swab specimens.
Time Frame
Baseline, Days 2, 3, 5, 8, 14 and 21
Title
Percentage of Participants With Undetectable RSV Viral Load
Description
Percentage of participants with undetectable RSV viral load was analyzed.
Time Frame
Baseline, Days 2, 3, 5, 8, 14 and 21
Title
Plasma Concentrations of Rilematovir
Description
Plasma concentrations of rilematovir were assessed. Participant wise data were reported for this outcome measure.
Time Frame
1 hour Post-dose (Day 1) and pre-dose (Day 2)
Title
Percentage of Participants With Acceptability and Palatability of the Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s)
Description
Acceptability and palatability were assessed by clinician electronic clinical outcome assessment (eCOA) questionnaire which consisted of 7 questions, 1- child took medicine easily, 2- disgusted expressions after tasting medicine, 3- cried after tasting medicine, 4- would not open mouth or turned head away to avoid medicine, 5- spit out or coughed out medicine, 6- gagged, 7- vomited (within 2 minutes of swallowing medicine).
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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 <75 percent [%] intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive). Cough or wheezing cannot be the only LRTI sign/symptom present, that is, at least one other LRTI sign/symptom needs to be present for eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arnold Palmer Hospital For Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
MultiCare Health Systems for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Interzonal General de Agudos Dr. Jose Penna
City
Bahia Blanca
ZIP/Postal Code
B8001DDU
Country
Argentina
Facility Name
Hospital Italiano Regional Del Sur
City
Bahía Blanca
ZIP/Postal Code
B8001HXM
Country
Argentina
Facility Name
Hospital General de Niños Pedro de Elizalde
City
Buenos Aires
ZIP/Postal Code
C1270AAN
Country
Argentina
Facility Name
Hospital Universitario Austral
City
Pilar
ZIP/Postal Code
1629
Country
Argentina
Facility Name
Instituto Médico Río Cuarto
City
Rio Cuarto
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Clinica Mayo de UMCB
City
San Miguel de Tucuman
ZIP/Postal Code
T4000IHE
Country
Argentina
Facility Name
Hospital del Niño Jesús
City
San Miguel de Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
ULB Hôpital Erasme
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
City
Botucatu
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro
City
Campinas
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Nucleo de Pesquisa do Hospital Pequeno Princípe
City
Curitiba
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
City
Fortaleza
ZIP/Postal Code
60840-285
Country
Brazil
Facility Name
Associação Hospitalar Moinhos de Vento
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
City
Ribeirão Preto
ZIP/Postal Code
14015-130
Country
Brazil
Facility Name
Fundacao Jose Luiz Egydio Setubal
City
Sao Paulo
ZIP/Postal Code
01227-200
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Votuporanga
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Facility Name
UMHAT 'Sveti Georgi'-Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT 'Kanev' EAD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT 'Aleksandrovska' EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
SHATCD 'Prof. Ivan Mitev' EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Capital Institute of Pediatrics
City
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100045
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
West China Second University Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610000
Country
China
Facility Name
Guangzhou Women And Children's Medical Center
City
Guangzhou
ZIP/Postal Code
510623
Country
China
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Facility Name
Tallinn Children's Hospital
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Universitätsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal GmbH
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Facility Name
Bethesda Gyermekkórház
City
Budapest
ZIP/Postal Code
H-1146
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Bacs-kiskun Megyei Korhaz
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Soroka University Medical Center
City
Beer-Sheba
ZIP/Postal Code
8457108
Country
Israel
Facility Name
Ruth Rappaport Children's Hospital, Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petah Tikva
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Pediatrics B, Safra Children's Hospital, Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky MC
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
A.O.U Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Facility Name
Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Department of Pediatrics University of Pavia, Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale degli Infermi
City
Ponderano
ZIP/Postal Code
13875
Country
Italy
Facility Name
Fukui Prefectural Hospital
City
Fukui-shi
ZIP/Postal Code
910-0846
Country
Japan
Facility Name
Fukuyama City Hospital
City
Fukuyama
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Kagoshima Children's Hospital
City
Hioki
ZIP/Postal Code
899-2503
Country
Japan
Facility Name
Teine Keijinkai Hospital
City
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Japan Community Health care Organization Kyushu Hospital
City
Kitakyushu-shi,
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781-0111
Country
Japan
Facility Name
Maebashi Red Cross Hospital
City
Maebashi
ZIP/Postal Code
371-0811
Country
Japan
Facility Name
Daido Hospital
City
Nagoya
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
National Hospital Organization Niigata National Hospital
City
Niigata
ZIP/Postal Code
945-8585
Country
Japan
Facility Name
National Hospital Organization Beppu Medical Center
City
Oita
ZIP/Postal Code
874-0011
Country
Japan
Facility Name
National Hospital Organization Saitama National Hospital
City
Saitama
ZIP/Postal Code
351-0102
Country
Japan
Facility Name
National Hospital Organization Ureshino Medical Center
City
Ureshino-shi
ZIP/Postal Code
843-0393
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University
City
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Korea Institute of Radiological and Medical Sciences
City
Seoul
ZIP/Postal Code
01812
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical Center, Eulji University
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
ZIP/Postal Code
1757
Country
Korea, Republic of
Facility Name
Children's Clinical University Hospital
City
Riga
ZIP/Postal Code
LV1005
Country
Latvia
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hospital Bintulu
City
Bintulu
ZIP/Postal Code
97000
Country
Malaysia
Facility Name
Hospital Miri
City
Miri
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
Hospital Sibu
City
Sibu
ZIP/Postal Code
96000
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Instituto Nacional de Pediatría
City
Ciudad de Mexico
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
Ciudad De Mexico
ZIP/Postal Code
6720
Country
Mexico
Facility Name
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro Medico Zambrano Hellion
City
Monterrey
ZIP/Postal Code
66278
Country
Mexico
Facility Name
Cevaxin Avenida Mexico
City
Panama
Country
Panama
Facility Name
Krakowski Szpital Specjalistyczny im Jana Pawla II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
92-328
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Lublinie
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego
City
Warszawa
ZIP/Postal Code
02-091
Country
Poland
Facility Name
DFNsP Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
97401
Country
Slovakia
Facility Name
Pediatric Pulmonology Clinic, University Hospital Bratislava
City
Bratislava
ZIP/Postal Code
82556
Country
Slovakia
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Univ. de Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Univ. de Getafe
City
Getafe
ZIP/Postal Code
28020
Country
Spain
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. 12 De Octubre
City
Madrid
ZIP/Postal Code
28051
Country
Spain
Facility Name
Hosp. Univ. Hm Monteprincipe
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hosp. Univ. Severo Ochoa
City
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hosp. Univ. Pta. de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28221
Country
Spain
Facility Name
Hosp. Puerta Del Sur
City
Mostoles
ZIP/Postal Code
28938
Country
Spain
Facility Name
Complejo Hosp. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Pozuelo de Alarcón
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Astrid Lindgrens barnsjukhus Solna
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Hsinchu MacKay Memorial Hospital
City
Hsinchu
ZIP/Postal Code
30071
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Chang Gung Medical Foundation
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Tropical Medicine Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiangmai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Infectious Disease Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Faculty of Medicine Chulalongkorn University
City
Pathumwan
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Cukurova University Medical Faculty Balcali Hospital
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital
City
Sarıyer
ZIP/Postal Code
34453
Country
Turkey
Facility Name
Karadeniz Teknik University Medical Faculty
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
MNPE City Children's Clinical Hospital № 6 of Dnipro City Council
City
Dnipro
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
ME 'Dnipropetrovsk Regional Children's Clinical Hospital of Dnipropetrovsk Regional Council'
City
Dnipro
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Kharkiv National Medical University on based CHPI Kharkiv Municipal Clinical Children's Hospital 16
City
Kharkiv
ZIP/Postal Code
61075
Country
Ukraine
Facility Name
MUNICIPAL NON-PROFIT ENTERPRISE 'Kryvyi Rih CITY HOSPITAL №16' Kryvyi Rih CITY COUNCIL
City
Kryvyi Rih
ZIP/Postal Code
50082
Country
Ukraine
Facility Name
Odessa Regional Child Hospital
City
Odessa
ZIP/Postal Code
65031
Country
Ukraine
Facility Name
SSU Division MU Ch of pediatrics of PGE with propedeutic pediatrics and children infections course
City
Sumy
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Sumy Regional Childrens Clinical Hospital
City
Sumy
ZIP/Postal Code
40031
Country
Ukraine
Facility Name
Municipal institution 'Vinnytsia Regional Clinical Children's Infectious Diseases Hospital'
City
Vinnytsia
ZIP/Postal Code
21032
Country
Ukraine
Facility Name
MNPE Zaporizhzhya Regional Clinical Children's Hospital of Zaporizhzhya Regional Council
City
Zaporizhzhia
ZIP/Postal Code
69063
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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