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CTRI Number  CTRI/2021/09/036588 [Registered on: 16/09/2021] Trial Registered Prospectively
Last Modified On: 07/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study is to evaluate Rilematovir for Acute Respiratory Tract Infection due to Respiratory Syncytial Virus for Hospitalized Infants and Children and Subsequently in Neonates.  
Scientific Title of Study   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) 
Trial Acronym  DAISY 
Secondary IDs if Any  
Secondary ID  Identifier 
128973  ClinicalTrials.gov 
2020-002023-11  EudraCT 
53718678RSV3001,Dated 17 August 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanish Davis 
Designation  R & D Director 
Affiliation  Johnson and Johnson Pvt. Ltd. 
Address  Arena Space, Behind Majas Bus Depot, Off. J. V. Link Road,Jogeshwari (E).Mumbai MAHARASHTRA 400060 India

Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanish Davis 
Designation  R & D Director 
Affiliation  Johnson and Johnson Pvt. Ltd. 
Address  Arena Space, Behind Majas Bus Depot, Off. J. V. Link Road,Jogeshwari (E).Mumbai MAHARASHTRA 400060 India

Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanish Davis 
Designation  R & D Director 
Affiliation  Johnson and Johnson Pvt. Ltd. 
Address  Arena Space, Behind Majas Bus Depot, Off. J. V. Link Road,Jogeshwari (E).Mumbai MAHARASHTRA 400060 India

Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  sdavis20@its.jnj.com  
 
Source of Monetary or Material Support  
Janssen Research & Development , LLC 
 
Primary Sponsor  
Name  Janssen Research Development LLC 
Address  Johnson and Johnson Pvt. Ltd., 501 Arena space, Behind Majas Bus Depot, off J.V. Link Road, Jogeshwari East, Mumbai400060 Maharashtra 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Belgium
Brazil
Bulgaria
Czech Republic
Germany
Hungary
Israel
Italy
Malaysia
Mexico
Poland
Republic of Korea
Russian Federation
Spain
Sweden
Taiwan
Thailand
Turkey
United States of America
India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amar Mohanrao Taksande  Datta Meghe Institute of Medical Sciences  Clinical Research Division, Block A, First Floor, Sawangi Meghe Wardha, Maharashtra 442004
Wardha
MAHARASHTRA 		 9822369233

amar.taksande@gmail.com 
Dr Sharad Agarkhedkar  Dr. D.Y.Patil Medical College  Dr. D.Y.Patil Medical College, Hospital and Research Center, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA 		 9822030122

agarkhedkar@gmail.com 
Dr Leslie Edward Simon Lewis  Kasturba Medical College Hospital  Manipal Centre for Clinical Research Mezzanine Floor of OLD KMC Library Building, Near KMC Dean Office, MAHE, Manipal – 576 104
Udupi
KARNATAKA 		 9449208476

leslie.lewis@manipal.edu 
Dr Ashish Ramesh Bavdekar   KEM Hospital Research Centre  Department of Pediatrics, Sardar Moodliar Road, Rasta Peth, Pune – 411011
Pune
MAHARASHTRA 		 919822056174

bavdekar@gmail.com 
Dr Mallikarjuna Honnali Bannajji  M S Ramaiah Medical College and Hospital  Department of Pediatrics,First Floor Room No: M S Ramaiah Nagar Bengaluru, Karnataka 560054
Bangalore
KARNATAKA 		 9448151124

honnalibannajji@yahoo.co.in 
Dr Raghvendra Singh  Maulana Azad Medical College & Associated Lok Nayak Hospital  Dept of Pediatrics, Ward No-19 Project Room, Opposite Genetic Lab, Bahadur Shah Zafar Marg, New Delhi – 110002
New Delhi
DELHI 		 9811898693

drraghvendrasingh@gmail.com 
Dr Somashekhar Nimbalkar  Shree Krishna Hospital  Department of Pediatrics & Nenonatology, ground floor,Gokalnagar,Karamsad, Gujarat 388 325
Anand
GUJARAT 		 9825087842

somu_somu@yahoo.com 
Dr Dinesh Kaul  Sir Ganga Ram Hospital  Room no. 1417, 4th Floor Admission building, Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi-110060
New Delhi
DELHI 		 9811211205

docdineshkaul@gmail.com 
Dr Padmasani  Sri Ramachandra Institute of Higher Education and Research   Clinical Research Facility, Basement, No.1, Ramachandra Nagar, Porur, Chennai- 600116, Tamil Nadu, India
Chennai
TAMIL NADU 		 9445140200

padmasani@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee, Ramaiah Medical College n Hosp situated at M S Ramaiah Medical College and Hospitals  Approved 
Ethics Committee, Dr. D Y Patil Vidyapeth  Approved 
Institutional Ethics Committee MAMC Maulana Azad Medical College   Submittted/Under Review 
Institutional Ethics Committee Sri Ramachandra University  Approved 
Institutional Ethics Committee, HMPCMCE  Submittted/Under Review 
Institutional Ethics Committees, Sharad Pawar Dental College, a Constituent College of Datta meghe Institute of medical Sciences (Deemed University)  Approved 
KEM Hospital Research Centre Ethics Committee   Approved 
MAHE Ethics Committee   Approved 
Sir Ganga Ram Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B974||Respiratory syncytial virus as thecause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  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  Rilematovir  greater than or equal to more than or equal to 28 days to less than less than 3 months age group 1 or greater than equal to 3 months to less than 6 months 
Intervention  Rilematovir  Participants of age group birth at term after at least 37 weeks of gestation to less than 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 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  5.00 Year(s)
Gender  Both 
Details  - 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 less than 75 percent intake of normal food amounts); dehydration; fever; disturbed sleep, or disturbed activity level (irritable/restless/agitated/less responsive)
- 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 
 
ExclusionCriteria 
Details  - 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
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Respiratory Syncytial Virus (RSV)Recovery Scale (RRS) - The RRS is an ordinal scale assessing a participant’s clinical status.  Upto day 8 
 
Secondary Outcome  
Outcome  TimePoints 
Time From First Study Dose to Resolution of key RSV Signs/Symptoms Based on ObsRO  Up to Day 21 
Percentage of Participants with Clinically
Resolved RSV Disease as Assessed by ClinRO Sign/Symptoms Questionnaire 		 Upto Day 8 
Time From Discharge to Resolution of key RSV Signs/Symptoms based on ObsRO Sign/Symptoms Questionnaire
 		 Up to Day 21  
Time From First Dosing to end of Oxygen Supplementation
 		 Up to Day 35 
Number of Participants with Post-baseline RSV-Related Complications
 		 Up to Day 35 
Number of Participants with Adverse Events  Upto Day 35 
Number of Participants with Abnormalities in Clinical Laboratory Values (Hematology,Clinical chemistry, and routine urinalysis)
 		 Up to Day 35 
Number of Participants with Abnormalities in Electrocardiograms (ECG)
 		 Up to Day 35 
Number of Participants with Abnormalities in Vital Signs n(Temperature, pulse/heart rate, and peripheral capillary oxygen saturation
[SpO2]) abnormalities will be assessed.
 		 Up to Day 35 
Time to Resolution of Signs/symptoms of RSV Disease as Assessed by ObsRO Signs/Symptoms Questionnaire  Up to Day 21
 
PRESORS ObsRO Signs/Symptoms
Questionnaire Scores 		 Up to Day 21 
Change From Baseline in PRESORS ObsRO Signs/Symptoms Questionnaire Scores Over Time  Baseline Up to Day 21 
Time to Improvement in ObsRO General Health Questions (GHQ)  Up to Day 21 
Time to Hospital Discharge From Start of Dosing  Up to Day 35 
Time to Readiness for Hospital Discharge  Up to Day 35 
Percentage of Participants Requiring Intensive Care Unit (ICU) Stay  Up to Day 35 
Duration of Requiring ICU Stay  Up to Day 35 
Percentage of Participants Requiring Rehospitalization for Respiratory/other
Reasons 		 Up to Day 35 
Time to end of Oxygen Supplementation  Up to Day 35 
Percentage of Participants Requiring Oxygen Supplementation  Up to Day 35 
Duration of Oxygen Supplementation  Up to Day 35 
Time to end of Supplemental
Feeding/hydration 		 Up to Day 35 
Percentage of Participants Requiring Hydration and/or Feeding by Intravenous (IV) Administration or Nasogastric Tube
 		 Up to Day 35 
Duration of Supplemental Feeding/hydration  Up to Day 35 
Time to end of Supplemental Oxygen and/or Feeding/hydration
 		 Up to Day 35 
Number of Participants with Medical Encounters and Treatments
 		 Up to Day 35 
Number of Participants with Antibiotic Treatment Episodes
 		 Up to Day 35 
Number of Participants with Systemic or Inhaled Corticosteroids and
Bronchodilators use 		 Up to Day 35 
RSV Viral Load Area Under the RSV Viral Load-time Curve [AUC]) From Immediately Prior to First Dose of Study Intervention (Baseline) Through Day 3,
Day 5, and Day 8 		 Baseline, Day 3, 5 and Day 8 
RSV Viral Load Over Time   From Baseline to Day 21  
Change From Baseline in RSV Viral Load Over Time
 		 Baseline to Day 21 
Percentage of Participants with Undetectable RSV Viral Load  Up to Day 21 
Number of Participants with Post-baseline Changes in the RSV F-gene Compared with Baseline Sequences  Up to Day 21 
Plasma Concentration of Rilematovir   Post-dose (Day 1) and pre-dose (Day 2) 
Acceptability and Palatability of the
Rilematovir Formulation as Assessed by Parent(s)/Caregiver(s) 		 Day 8 
 
Target Sample Size   Total Sample Size="737"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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). 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 the completion of the 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.   
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