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

NCT ID: NCT04583280

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2022-03-18

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.

Conditions

Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rilematovir

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

Group Type: EXPERIMENTAL

Rilematovir

Intervention Type: DRUG

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.

Rilematovir X mg/kg

Intervention Type: DRUG

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.

Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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.

Interventions

Rilematovir

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

Rilematovir X mg/kg

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

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

JNJ-53718678; JNJ-53718678

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Arnold Palmer Hospital For Children

Orlando, Florida, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Jacobi Medical Center

The Bronx, New York, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

MultiCare Health Systems for Research and Innovation

Tacoma, Washington, United States

Hospital Interzonal General de Agudos Dr. Jose Penna

Bahía Blanca, , Argentina

Hospital Italiano Regional Del Sur

Bahía Blanca, , Argentina

Hospital General de Niños Pedro de Elizalde

Buenos Aires, , Argentina

Hospital Universitario Austral

Pilar, , Argentina

Instituto Medico Rio Cuarto

Río Cuarto, , Argentina

Hospital del Niño Jesús

San Miguel de Tucumán, , Argentina

Clinica Mayo de UMCB

San Miguel de Tucumán, , Argentina

ULB Hôpital Erasme

Anderlecht, , Belgium

AZ Sint Jan Brugge Oostende AV

Bruges, , Belgium

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires Saint Luc

Brussels, , Belgium

UZ Leuven

Leuven, , Belgium

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, , Brazil

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, , Brazil

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, , Brazil

Nucleo de Pesquisa do Hospital Pequeno Princípe

Curitiba, , Brazil

Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

Fortaleza, , Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, , Brazil

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, , Brazil

Fundacao Jose Luiz Egydio Setubal

São Paulo, , Brazil

Santa Casa de Misericórdia de Votuporanga

Votuporanga, , Brazil

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, , Bulgaria

UMHAT 'Kanev' EAD

Rousse, , Bulgaria

Acibadem City Clinic Tokuda Hospital

Sofia, , Bulgaria

UMHAT 'Aleksandrovska' EAD

Sofia, , Bulgaria

SHATCD 'Prof. Ivan Mitev' EAD

Sofia, , Bulgaria

Capital Institute of Pediatrics

Beijing, , China

Beijing Children's Hospital, Capital Medical University

Beijing, , China

Peking University Third Hospital

Beijing, , China

West China Second University Hospital, Sichuan University

Chengdu, , China

Guangzhou Women And Children's Medical Center

Guangzhou, , China

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

Thomayerova nemocnice

Prague, , Czechia

Tallinn Children's Hospital

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Universitätsklinik Freiburg

Freiburg im Breisgau, , Germany

HELIOS Klinikum Wuppertal GmbH

Wuppertal, , Germany

Universitatsklinikum Wurzburg

Würzburg, , Germany

Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika

Budapest, , Hungary

Bethesda Gyermekkórház

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Bacs-kiskun Megyei Korhaz

Kecskemét, , Hungary

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, , Hungary

Szegedi Tudomanyegyetem

Szeged, , Hungary

Csolnoky Ferenc Korhaz

Veszprém, , Hungary

Soroka University Medical Center

Beersheba, , Israel

Ruth Rappaport Children's Hospital, Rambam Health Care Campus

Haifa, , Israel

Schneider Children's Medical Center

Petah Tikva, , Israel

Pediatrics B, Safra Children's Hospital, Tel Hashomer

Ramat Gan, , Israel

Sourasky MC

Tel Aviv, , Israel

A O U Sant Orsola Malpighi

Bologna, , Italy

Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Department of Pediatrics University of Pavia, Policlinico San Matteo

Pavia, , Italy

Ospedale degli Infermi

Ponderano, , Italy

Fukui Prefectural Hospital

Fukui-shi, , Japan

Fukuyama City Hospital

Fukuyama, , Japan

Kagoshima Children's Hospital

Hioki, , Japan

Teine Keijinkai Hospital

Hokkaido, , Japan

National Hospital Organization Kanazawa Medical Center

Ishikawa, , Japan

Japan Community Health care Organization Kyushu Hospital

Kitakyushu-shi, , Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

Kochi Health Sciences Center

Kochi, , Japan

Maebashi Red Cross Hospital

Maebashi, , Japan

Kojunkai Daido Hospital

Nagoya, , Japan

National Hospital Organization Niigata National Hospital

Niigata, , Japan

National Hospital Organization Beppu Medical Center

Ōita, , Japan

National Hospital Organization Saitama National Hospital

Saitama, , Japan

National Hospital Organization Ureshino Medical Center

Ureshino-shi, , Japan

Yamanashi Prefectural Central Hospital

Yamanashi, , Japan

Children's Clinical University Hospital

Riga, , Latvia

Hospital Selayang

Batu Caves, , Malaysia

Hospital Bintulu

Bintulu, , Malaysia

Hospital Miri

Miri, , Malaysia

Hospital Sibu

Sibu, , Malaysia

Hospital Taiping

Taiping, , Malaysia

Instituto Nacional de Pediatría

Mexico City, , Mexico

Hospital Infantil de Mexico Federico Gomez

Mexico City, , Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, , Mexico

Centro Medico Zambrano Hellion

Monterrey, , Mexico

Cevaxin Avenida Mexico

Panama City, , Panama

Krakowski Szpital Specjalistyczny im Jana Pawla II

Krakow, , Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, , Poland

Uniwersytecki Szpital Dzieciecy w Lublinie

Lublin, , Poland

Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego

Warsaw, , Poland

DFNsP Banska Bystrica

Banská Bystrica, , Slovakia

Pediatric Pulmonology Clinic, University Hospital Bratislava

Bratislava, , Slovakia

Kyungpook National University Hospital

Daegu, , South Korea

CHA Bundang Medical Center, CHA University

Gyeonggi-do, , South Korea

Korea Institute of Radiological and Medical Sciences

Seoul, , South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Inje University Sanggye Paik Hospital

Seoul, , South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, , Spain

Hosp. Univ. de Cruces

Barakaldo, , Spain

Hosp Reina Sofia

Córdoba, , Spain

Hosp. Univ. de Getafe

Getafe, , Spain

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. Hm Monteprincipe

Madrid, , Spain

Hosp. Univ. Severo Ochoa

Madrid, , Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , Spain

Hosp. Puerta Del Sur

Móstoles, , Spain

Complejo Hosp. de Navarra

Pamplona, , Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Astrid Lindgrens barnsjukhus Solna

Stockholm, , Sweden

Hsinchu MacKay Memorial Hospital

Hsinchu, , Taiwan

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Chang Gung Medical Foundation

Taoyuan, , Taiwan

Tropical Medicine Hospital, Mahidol University

Bangkok, , Thailand

Siriraj Hospital Mahidol University

Bangkok, , Thailand

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, , Thailand

Srinagarind Hospital

Khon Kaen, , Thailand

Bamrasnaradura Infectious Disease Institute

Nonthaburi, , Thailand

Faculty of Medicine Chulalongkorn University

Pathumwan, , Thailand

Cukurova University Medical Faculty Balcali Hospital

Adana, , Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital

Sarıyer, , Turkey (Türkiye)

Karadeniz Teknik University Medical Faculty

Trabzon, , Turkey (Türkiye)

MNPE City Children's Clinical Hospital № 6 of Dnipro City Council

Dnipro, , Ukraine

ME 'Dnipropetrovsk Regional Children's Clinical Hospital of Dnipropetrovsk Regional Council'

Dnipro, , Ukraine

Kharkiv National Medical University on based CHPI Kharkiv Municipal Clinical Children's Hospital 16

Kharkiv, , Ukraine

MUNICIPAL NON-PROFIT ENTERPRISE 'Kryvyi Rih CITY HOSPITAL №16' Kryvyi Rih CITY COUNCIL

Kryvyi Rih, , Ukraine

Odessa Regional Child Hospital

Odesa, , Ukraine

SSU Division MU Ch of pediatrics of PGE with propedeutic pediatrics and children infections course

Sumy, , Ukraine

Sumy Regional Childrens Clinical Hospital

Sumy, , Ukraine

Municipal institution 'Vinnytsia Regional Clinical Children's Infectious Diseases Hospital'

Vinnytsia, , Ukraine

MNPE Zaporizhzhya Regional Clinical Children's Hospital of Zaporizhzhya Regional Council

Zaporizhzhia, , Ukraine

Countries

United States; Argentina; Belgium; Brazil; Bulgaria; China; Czechia; Estonia; Germany; Hungary; Israel; Italy; Japan; Latvia; Malaysia; Mexico; Panama; Poland; Slovakia; South Korea; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-002023-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

53718678RSV3001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108899

Identifier Type: -

Identifier Source: org_study_id