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

NCT04583280 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: CR1088992020-002023-1153718678RSV3001
• Study Type: interventional
• Target: 28
• Locations: 25 countries
• Sites: 140

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).

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Day 8

Secondary Outcomes (20)

• Percentage of Participants Clinically Resolved From RSV Disease Based on the Clinician Reported Outcome (ClinRO) Sign/Symptoms at Day 8

  Day 8

• 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

  Up to Day 21

• Number of Participants With Post-baseline RSV-related Complications

  Up to Day 35

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Day 1 up to Day 35

• Number of Participants With Abnormalities in Clinical Laboratory Values

  Up to Day 35

Study Arms (2)

Rilematovir

EXPERIMENTAL

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

Drug: Rilematovir; Drug: Rilematovir X mg/kg

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

Rilematovir 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.

Also known as: JNJ-53718678

Rilematovir

Rilematovir X mg/kg 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.

Also known as: JNJ-53718678

Rilematovir

Placebo 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.

Placebo

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (142)

Arnold Palmer Hospital For Children

Orlando, Florida, 32806, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

MultiCare Health Systems for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Hospital Interzonal General de Agudos Dr. Jose Penna

Bahía Blanca, B8001DDU, Argentina

Location

Hospital Italiano Regional Del Sur

Bahía Blanca, B8001HXM, Argentina

Location

Hospital General de Niños Pedro de Elizalde

Buenos Aires, C1270AAN, Argentina

Location

Hospital Universitario Austral

Pilar, 1629, Argentina

Location

Instituto Medico Rio Cuarto

Río Cuarto, 5800, Argentina

Location

Hospital del Niño Jesús

San Miguel de Tucumán, 4000, Argentina

Location

Clinica Mayo de UMCB

San Miguel de Tucumán, T4000IHE, Argentina

Location

ULB Hôpital Erasme

Anderlecht, 1070, Belgium

Location

AZ Sint Jan Brugge Oostende AV

Bruges, 8000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, 30150-221, Brazil

Location

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

Botucatu, 18618-686, Brazil

Location

Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

Campinas, 13060-904, Brazil

Location

Nucleo de Pesquisa do Hospital Pequeno Princípe

Curitiba, 80250-060, Brazil

Location

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

Fortaleza, 60840-285, Brazil

Location

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035-001, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, 14015-130, Brazil

Location

Fundacao Jose Luiz Egydio Setubal

São Paulo, 01227-200, Brazil

Location

Santa Casa de Misericórdia de Votuporanga

Votuporanga, 15500-003, Brazil

Location

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, 4000, Bulgaria

Location

UMHAT 'Kanev' EAD

Rousse, 7002, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital

Sofia, 1407, Bulgaria

Location

UMHAT 'Aleksandrovska' EAD

Sofia, 1431, Bulgaria

Location

SHATCD 'Prof. Ivan Mitev' EAD

Sofia, 1606, Bulgaria

Location

Capital Institute of Pediatrics

Beijing, 100000, China

Location

Beijing Children's Hospital, Capital Medical University

Beijing, 100045, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

West China Second University Hospital, Sichuan University

Chengdu, 610000, China

Location

Guangzhou Women And Children's Medical Center

Guangzhou, 510623, China

Location

Fakultni nemocnice Brno

Brno, 613 00, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 10034, Czechia

Location

Thomayerova nemocnice

Prague, 14059, Czechia

Location

Tallinn Children's Hospital

Tallinn, 13419, Estonia

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

HELIOS Klinikum Wuppertal GmbH

Wuppertal, 42283, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika

Budapest, 1094, Hungary

Location

Bethesda Gyermekkórház

Budapest, H-1146, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Bacs-kiskun Megyei Korhaz

Kecskemét, 6000, Hungary

Location

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, 3526, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, 6720, Hungary

Location

Csolnoky Ferenc Korhaz

Veszprém, 8200, Hungary

Location

Soroka University Medical Center

Beersheba, 8457108, Israel

Location

Ruth Rappaport Children's Hospital, Rambam Health Care Campus

Haifa, 31096, Israel

Location

Schneider Children's Medical Center

Petah Tikva, 4920235, Israel

Location

Pediatrics B, Safra Children's Hospital, Tel Hashomer

Ramat Gan, 52621, Israel

Location

Sourasky MC

Tel Aviv, 6423906, Israel

Location

A O U Sant Orsola Malpighi

Bologna, 40100, Italy

Location

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

Milan, 20122, Italy

Location

Department of Pediatrics University of Pavia, Policlinico San Matteo

Pavia, 27100, Italy

Location

Ospedale degli Infermi

Ponderano, 13875, Italy

Location

Fukui Prefectural Hospital

Fukui-shi, 910-0846, Japan

Location

Fukuyama City Hospital

Fukuyama, 721-8511, Japan

Location

Kagoshima Children's Hospital

Hioki, 899-2503, Japan

Location

Teine Keijinkai Hospital

Hokkaido, 006-8555, Japan

Location

National Hospital Organization Kanazawa Medical Center

Ishikawa, 920 8650, Japan

Location

Japan Community Health care Organization Kyushu Hospital

Kitakyushu-shi, 806-8501, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

Kochi Health Sciences Center

Kochi, 781-0111, Japan

Location

Maebashi Red Cross Hospital

Maebashi, 371-0811, Japan

Location

Kojunkai Daido Hospital

Nagoya, 457-8511, Japan

Location

National Hospital Organization Niigata National Hospital

Niigata, 945-8585, Japan

Location

National Hospital Organization Beppu Medical Center

Ōita, 874-0011, Japan

Location

National Hospital Organization Saitama National Hospital

Saitama, 351-0102, Japan

Location

National Hospital Organization Ureshino Medical Center

Ureshino-shi, 843-0393, Japan

Location

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506, Japan

Location

Children's Clinical University Hospital

Riga, LV1005, Latvia

Location

Hospital Selayang

Batu Caves, 68100, Malaysia

Location

Hospital Bintulu

Bintulu, 97000, Malaysia

Location

Hospital Miri

Miri, 98000, Malaysia

Location

Hospital Sibu

Sibu, 96000, Malaysia

Location

Hospital Taiping

Taiping, 34000, Malaysia

Location

Instituto Nacional de Pediatría

Mexico City, 04530, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, 6720, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

Centro Medico Zambrano Hellion

Monterrey, 66278, Mexico

Location

Cevaxin Avenida Mexico

Panama City, Panama

Location

Krakowski Szpital Specjalistyczny im Jana Pawla II

Krakow, 31 202, Poland

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

Lodz, 92 328, Poland

Location

Uniwersytecki Szpital Dzieciecy w Lublinie

Lublin, 20-093, Poland

Location

Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego

Warsaw, 02 091, Poland

Location

DFNsP Banska Bystrica

Banská Bystrica, 97401, Slovakia

Location

Pediatric Pulmonology Clinic, University Hospital Bratislava

Bratislava, 82556, Slovakia

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

CHA Bundang Medical Center, CHA University

Gyeonggi-do, 13496, South Korea

Location

Korea Institute of Radiological and Medical Sciences

Seoul, 01812, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 1757, South Korea

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. Univ. de Cruces

Barakaldo, 48903, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. Univ. de Getafe

Getafe, 28020, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp. Univ. Hm Monteprincipe

Madrid, 28660, Spain

Location

Hosp. Univ. Severo Ochoa

Madrid, 28911, Spain

Location

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, 28221, Spain

Location

Hosp. Puerta Del Sur

Móstoles, 28938, Spain

Location

Complejo Hosp. de Navarra

Pamplona, 31008, Spain

Location

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Astrid Lindgrens barnsjukhus Solna

Stockholm, 14186, Sweden

Location

Hsinchu MacKay Memorial Hospital

Hsinchu, 30071, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Chang Gung Medical Foundation

Taoyuan, 33305, Taiwan

Location

Tropical Medicine Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Infectious Disease Institute

Nonthaburi, 11000, Thailand

Location

Faculty of Medicine Chulalongkorn University

Pathumwan, 10330, Thailand

Location

Cukurova University Medical Faculty Balcali Hospital

Adana, 01330, Turkey (Türkiye)

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06560, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty

Istanbul, 34390, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital

Sarıyer, 34453, Turkey (Türkiye)

Location

Karadeniz Teknik University Medical Faculty

Trabzon, 61080, Turkey (Türkiye)

Location

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

Dnipro, 49000, Ukraine

Location

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

Dnipro, 49100, Ukraine

Location

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

Kharkiv, 61075, Ukraine

Location

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

Kryvyi Rih, 50082, Ukraine

Location

Odessa Regional Child Hospital

Odesa, 65031, Ukraine

Location

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

Sumy, 40022, Ukraine

Location

Sumy Regional Childrens Clinical Hospital

Sumy, 40031, Ukraine

Location

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

Vinnytsia, 21032, Ukraine

Location

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

Zaporizhzhia, 69063, Ukraine

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

JNJ-53718678

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Limitations and Caveats

As the study was terminated early, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety, and selected PK and efficacy parameters only.

Results Point of Contact

• Title: Senior Director Medical Leader
• Organization: Janssen Research & Development LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 12, 2020
• Study Start: September 6, 2021
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: February 4, 2025
• Results First Posted: April 10, 2023

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

TH (6); ES (14); SE (1); DE (3); HU (8); PA (1); IL (5); CN (5); ME (4); SL (2); KR (7); TU (7); BE (5); BR (9); UA (9); CZ (3); MY (5); IT (4); JP (15); LA (1); US (5); AR (7); BU (5); PL (4); TW (5)