Respiratory Tract InfectionsPhase 3DAISYNCT04583280
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
A Phase 3 study testing Rilematovir and Rilematovir X mg/kg in people with Respiratory Tract Infections, run by Janssen Research & Development, LLC at 142 sites in 26 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 day to 5 years
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Rilematovir and Rilematovir X mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 142 sitesin 26 countries
- Study dates
- 6 Sep 2021to 18 Mar 2022
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
142 sites in 26 countries.
142 sites in 26 countries
Japan15 sites
Fukui Prefectural Hospital
Fukui-shi, 910-0846
Fukuyama City Hospital
Fukuyama, 721-8511
Kagoshima Children's Hospital
Hioki, 899-2503
Teine Keijinkai Hospital
Hokkaido, 006-8555
National Hospital Organization Kanazawa Medical Center
Ishikawa, 920 8650
Japan Community Health care Organization Kyushu Hospital
Kitakyushu-shi, 806-8501
Kobe City Medical Center General Hospital
Kobe, 650-0047
Kochi Health Sciences Center
Kochi, 781-0111
Maebashi Red Cross Hospital
Maebashi, 371-0811
Kojunkai Daido Hospital
Nagoya, 457-8511
National Hospital Organization Niigata National Hospital
Niigata, 945-8585
National Hospital Organization Beppu Medical Center
Ōita, 874-0011
National Hospital Organization Saitama National Hospital
Saitama, 351-0102
National Hospital Organization Ureshino Medical Center
Ureshino-shi, 843-0393
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506
Spain14 sites
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp. Univ. de Cruces
Barakaldo, 48903
Hosp Reina Sofia
Córdoba, 14004
Hosp. Univ. de Getafe
Getafe, 28020
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Univ. La Paz
Madrid, 28046
Hosp. Univ. Hm Monteprincipe
Madrid, 28660
Hosp. Univ. Severo Ochoa
Madrid, 28911
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, 28221
Hosp. Puerta Del Sur
Móstoles, 28938
Complejo Hosp. de Navarra
Pamplona, 31008
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Brazil9 sites
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
Botucatu, 18618-686
Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro
Campinas, 13060-904
Nucleo de Pesquisa do Hospital Pequeno Princípe
Curitiba, 80250-060
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
Fortaleza, 60840-285
Associacao Hospitalar Moinhos de Vento
Porto Alegre, 90035-001
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, 14015-130
Fundacao Jose Luiz Egydio Setubal
São Paulo, 01227-200
Santa Casa de Misericórdia de Votuporanga
Votuporanga, 15500-003
Ukraine9 sites
MNPE City Children's Clinical Hospital № 6 of Dnipro City Council
Dnipro, 49000
ME 'Dnipropetrovsk Regional Children's Clinical Hospital of Dnipropetrovsk Regional Council'
Dnipro, 49100
Kharkiv National Medical University on based CHPI Kharkiv Municipal Clinical Children's Hospital 16
Kharkiv, 61075
MUNICIPAL NON-PROFIT ENTERPRISE 'Kryvyi Rih CITY HOSPITAL №16' Kryvyi Rih CITY COUNCIL
Kryvyi Rih, 50082
Odessa Regional Child Hospital
Odesa, 65031
SSU Division MU Ch of pediatrics of PGE with propedeutic pediatrics and children infections course
Sumy, 40022
Sumy Regional Childrens Clinical Hospital
Sumy, 40031
Municipal institution 'Vinnytsia Regional Clinical Children's Infectious Diseases Hospital'
Vinnytsia, 21032
MNPE Zaporizhzhya Regional Clinical Children's Hospital of Zaporizhzhya Regional Council
Zaporizhzhya, 69063
Hungary8 sites
Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika
Budapest, 1094
Bethesda Gyermekkórház
Budapest, H-1146
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Bacs-kiskun Megyei Korhaz
Kecskemét, 6000
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
Szegedi Tudomanyegyetem
Szeged, 6720
Csolnoky Ferenc Korhaz
Veszprém, 8200
Argentina7 sites
Hospital Interzonal General de Agudos Dr. Jose Penna
Bahía Blanca, B8001DDU
Hospital Italiano Regional Del Sur
Bahía Blanca, B8001HXM
Hospital General de Niños Pedro de Elizalde
Buenos Aires, C1270AAN
Hospital Universitario Austral
Pilar, 1629
Instituto Medico Rio Cuarto
Río Cuarto, 5800
Hospital del Niño Jesús
San Miguel de Tucumán, 4000
Clinica Mayo de UMCB
San Miguel de Tucumán, T4000IHE
South Korea7 sites
Kyungpook National University Hospital
Daegu, 41944
CHA Bundang Medical Center, CHA University
Gyeonggi-do, 13496
Korea Institute of Radiological and Medical Sciences
Seoul, 01812
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Kangbuk Samsung Hospital
Seoul, 03181
Samsung Medical Center
Seoul, 06351
Inje University Sanggye Paik Hospital
Seoul, 1757
Turkey (Türkiye)7 sites
Cukurova University Medical Faculty Balcali Hospital
Adana, 01330
Hacettepe University Medical Faculty
Ankara, 06100
Gazi University Medical Faculty
Ankara, 06560
Istanbul University Istanbul Medical Faculty
Istanbul, 34390
Ege University Medical Faculty
Izmir, 35100
Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital
Sariyer, 34453
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
Thailand6 sites
Tropical Medicine Hospital, Mahidol University
Bangkok, 10400
Siriraj Hospital Mahidol University
Bangkok, 10700
Maharaj Nakorn Chiangmai Hospital
Chiang Mai, 50200
Srinagarind Hospital
Khon Kaen, 40002
Bamrasnaradura Infectious Disease Institute
Nonthaburi, 11000
Faculty of Medicine Chulalongkorn University
Pathumwan, 10330
United States5 sites
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
Arnold Palmer Hospital For Children
Orlando, Florida, 32806
MultiCare Health Systems for Research and Innovation
Tacoma, Washington, 98405
Jacobi Medical Center
The Bronx, New York, 10461
Belgium5 sites
ULB Hôpital Erasme
Anderlecht, 1070
AZ Sint Jan Brugge Oostende AV
Bruges, 8000
UZ Brussel
Brussels, 1090
Cliniques Universitaires Saint Luc
Brussels, 1200
UZ Leuven
Leuven, 3000
Bulgaria5 sites
UMHAT 'Sveti Georgi'-Plovdiv
Plovdiv, 4000
UMHAT 'Kanev' EAD
Rousse, 7002
Acibadem City Clinic Tokuda Hospital
Sofia, 1407
UMHAT 'Aleksandrovska' EAD
Sofia, 1431
SHATCD 'Prof. Ivan Mitev' EAD
Sofia, 1606
China5 sites
Capital Institute of Pediatrics
Beijing, 100000
Beijing Children's Hospital, Capital Medical University
Beijing, 100045
Peking University Third Hospital
Beijing, 100191
West China Second University Hospital, Sichuan University
Chengdu, 610000
Guangzhou Women And Children's Medical Center
Guangzhou, 510623
Israel5 sites
Soroka University Medical Center
Beersheba, 8457108
Ruth Rappaport Children's Hospital, Rambam Health Care Campus
Haifa, 31096
Schneider Children's Medical Center
Petah Tikva, 4920235
Pediatrics B, Safra Children's Hospital, Tel Hashomer
Ramat Gan, 52621
Sourasky MC
Tel Aviv, 6423906
Malaysia5 sites
Hospital Selayang
Batu Caves, 68100
Hospital Bintulu
Bintulu, 97000
Hospital Miri
Miri, 98000
Hospital Sibu
Sibu, 96000
Hospital Taiping
Taiping, 34000
Taiwan5 sites
Hsinchu MacKay Memorial Hospital
Hsinchu, 30071
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
National Taiwan University Hospital
Taipei, 10002
Mackay Memorial Hospital
Taipei, 10449
Chang Gung Medical Foundation
Taoyuan City, 33305
Italy4 sites
A O U Sant Orsola Malpighi
Bologna, 40100
Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Department of Pediatrics University of Pavia, Policlinico San Matteo
Pavia, 27100
Ospedale degli Infermi
Ponderano, 13875
Mexico4 sites
Instituto Nacional de Pediatría
Mexico City, 04530
Hospital Infantil de Mexico Federico Gomez
Mexico City, 6720
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
Centro Medico Zambrano Hellion
Monterrey, 66278
Poland4 sites
Krakowski Szpital Specjalistyczny im Jana Pawla II
Krakow, 31 202
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, 92 328
Uniwersytecki Szpital Dzieciecy w Lublinie
Lublin, 20-093
Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego
Warsaw, 02 091
Czechia3 sites
Fakultni nemocnice Brno
Brno, 613 00
Fakultni nemocnice Kralovske Vinohrady
Prague, 10034
Thomayerova nemocnice
Prague, 14059
Germany3 sites
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
HELIOS Klinikum Wuppertal GmbH
Wuppertal, 42283
Universitatsklinikum Wurzburg
Würzburg, 97080
Estonia2 sites
Tallinn Children's Hospital
Tallinn, 13419
Tartu University Hospital
Tartu, 51014
Slovakia2 sites
DFNsP Banska Bystrica
Banská Bystrica, 97401
Pediatric Pulmonology Clinic, University Hospital Bratislava
Bratislava, 82556
About this study
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)
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).
Read the 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
- Being tested
- Rilematovir, Rilematovir X mg/kg, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilematovirDrug
Also called JNJ-53718678
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/kgDrug
Also called JNJ-53718678
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Rilematovir | Experimental | Participants will receive rilematovir orally based on body weight and age group. Receives: Drug: Rilematovir; Drug: Rilematovir X mg/kg |
| Placebo | Experimental | Participants will receive matching placebo of rilematovir based on body weight and age group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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
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.
Measured: Up to Day 21
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.
Measured: Up to Day 35
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.
Measured: Day 1 up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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).
Measured: Up to Day 35
Percentage of Participants Requiring Intensive Care Unit (ICU) Stay After First Dose of Rilematovir
Percentage of participants requiring ICU stay was analyzed and reported.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Baseline, Days 2, 3, 5, 8, 14 and 21
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.
Measured: Baseline, Days 2, 3, 5, 8, 14 and 21
Percentage of Participants With Undetectable RSV Viral Load
Percentage of participants with undetectable RSV viral load was analyzed.
Measured: Baseline, Days 2, 3, 5, 8, 14 and 21
Plasma Concentrations of Rilematovir
Plasma concentrations of rilematovir were assessed. Participant wise data were reported for this outcome measure.
Measured: 1 hour Post-dose (Day 1) and pre-dose (Day 2)
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).
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start6 Sep 2021
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Why it stopped: Janssen made the strategic decision to discontinue the DAISY study. This decision is not based on any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583280
- Sponsor's protocol ID
- CR108899
- Other IDs
- 2020-002023-11, 53718678RSV3001
- Acronym
- DAISY
- Status last verified
- Jan 2025
- First submitted
- 9 Oct 2020
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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