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CTRI Number  CTRI/2022/01/039085 [Registered on: 03/01/2022] 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, Placebo Controlled Trial 
Public Title of Study   A Study of Rilematovir in Adult patients with Respiratory Syncytial Virus (RSV) Infection 
Scientific Title of Study   A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection who are at High Risk for RSV-related Disease Progression  
Trial Acronym  PRIMROSE 
Secondary IDs if Any  
Secondary ID  Identifier 
2020-005980-30  EudraCT 
53718678RSV2008 dated 12-March-2021  Protocol Number 
IND 128973  ClinicalTrials.gov 
 
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 (Suburban)
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 (Suburban)
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 (Suburban)
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
Brazil
Bulgaria
Canada
Germany
Hungary
India
Italy
Japan
Mexico
Poland
Russian Federation
South Africa
Spain
Sweden
Thailand
Turkey
Ukraine
United States of America  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Purshotam Koradia   BAPS Pramukh Swami Hospital  Ground Floor Clinical Research Department Shri Pramukh Swami Maharaj Marg, Adajan Char Rasta, Adajan, Surat-395009, Gujarat, India
Surat
GUJARAT 		 9825312027

purushottam_koradia@yahoo.co.in 
Dr Shrikant Krishnamurthy  Hindusthan Hospital  Room No 522 3 & 523 3 Nava India Road Udaiyampalayam Coimbatore 641028 Tamilnadu India
Coimbatore
TAMIL NADU 		 9894257706

drsrikanthcbe@gmail.com 
Dr Ashish Nikhare   Lata Mangeshkar Multispecialty Hospital,  5 YMCA Complex Maharajbagh Road Sitabuldi Nagpur 440001 Maharashtra India
Nagpur
MAHARASHTRA 		 8149927258

ashoonikh@gmail.com 
Dr Rajkumar Nikhalje   Lifepoint Multispecialty Hospital,  First Floor, 145/1, Mumbai Bangalore Highway near hotel Sayaji Wakad Pune 411057 Maharashtra India
Pune
MAHARASHTRA 		 9028560535

rajkumarnikalje@yahoo.com 
Dr Humsraj Alva   Vinaya Hospital and Research Centre  Third Floor, Clinical Research Karangalpady, Mangalore Karnataka 575003
Bangalore
KARNATAKA 		 9343562622

hansraj.alva@vhrc.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
BAPS Pramukh Swami Hospital Institutional Ethics Committee,  Submittted/Under Review 
Ethics Committee Vinaya Hospital,  Approved 
Institutional Ethics Committee,  Submittted/Under Review 
Institutional Human Ethics Committee  Approved 
LPR 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: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days. 
Intervention  Rilematovir  Participants will receive oral dose of rilematovir 250 milligrams mg twice daily bid for 7 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Presented to the healthcare facility with symptoms suggestive of a diagnosis of
acute respiratory syncytial virus RSV infection

Has at least 2 symptoms of lower respiratory tract disease LRTD one of which
must be scored as at least moderate if the symptoms did not pre-exist before
RSV onset or one of which is scored worse than usual if the symptoms preexisted
Tested positive for RSV infection using a molecularbased diagnostic assay
polymerase chain reaction PCR or other on a bilateral nasal midturbinate
swab sample
Has at least one of the following high risk conditions that predispose them to
RSVrelated disease progression a age greater than or equal 65 years
b congestive heart failure CHF c chronic obstructive pulmonary disease
COPD dasthma
Randomized to study intervention treatment within 72 hours after onset of any
of the RSV symptoms or worsening of pre existing symptoms
Not be hospitalized during screening emergency room or hospital observation
status for an anticipated duration of less than 24 hours are not considered as
hospitalization 
 
ExclusionCriteria 
Details  - Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the
excipients of rilematovir or placebo formulation
- Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial
arrhythmia, or sustained ventricular arrhythmia
- Participant has known or suspected (from medical history or participantexamination) chronic or acute hepatitis B or C infection
- Immunocompromised conditions
- Living in institutional care or assisted living facility and also receiving acute care
management for any respiratory condition 
 
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 
Time to Resolution of Respiratory Syncytial
Virus (RSV) Lower Respiratory Tract
Disease (LRTD) Symptoms as Assessed
by Respiratory Infection Intensity and
Impact Questionnaire (RiiQ Symptom
Scale) 		 From initiation of study treatment up to Day
35 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of Participants with Post Baseline RSV related Complications  From initiation of study treatment up to Day 35 
Percentage of Participants with New Antibiotic Use or New or Increased Use inCorticosteroids or Home Oxygen Supplementation
Bronchodilator Nebulizer Systemic 		 From initiation of study treatment up to Day 35 
Percentage of Participants with
Unscheduled Outpatient Clinic Visits,
Emergency Room Visits or Hospitalization for Respiratory Infection 		 From initiation of study treatment up to Day
35 
Percentage of Participants Meeting a
Composite Endpoint of Either Developing
RSV Related Complications andor Needing
RSV related Medical Attendance 		 From initiation of study treatment up to Day
35 
Percentage of Participants with Adverse
Events AEs as Measure of Safety and Tolerability 		 From initiation of study treatment up to Day
35 
Percentage of Participants with
Abnormalities in Clinical Laboratory Tests 		 From initiation of study treatment up to Day
35 
Percentage of Participants with
Abnormalities in Electrocardiograms
ECGs 		 From initiation of study treatment up to Day
14 
Percentage of Participants with
Abnormalities in Physical Examination 		 From initiation of study treatment up to Day
35 
Percentage of Participants with
Abnormalities in Vital Signs 		 From initiation of study treatment up to Day
35 
Change from Baseline Over Time in
Severity of the RSV LRTD Symptoms as
Assessed by the Participant Using the RiiQ
Symptom Scale Score 		 Baseline up to Day 35 
Time to Resolution of LRTD Symptoms and
2 Systemic symptoms as Assessed by RiiQ
Symptom Scale Score 		 From initiation of study treatment up to Day
35 
Time to Resolution of the Overall RSV
Symptoms Upper Respiratory Tract
Disease URTD LRTD, and 2 Systemic
Symptoms as Assessed by RiiQ Symptom
Scale Score 		 From initiation of study treatment up to Day
35 
Time to Resolution of all RSV Symptoms as
Assessed by RiiQ Symptom Scale Score 		 From initiation of study treatment up to Day
35 
Time to Resolution of each Separate RSV
LRTD Symptom as Assessed by RiiQ
Symptom Scale Score 		 From initiation of study treatment up to Day
35 
Time to Resolution of Respiratory Infection
Symptoms as Assessed by Patient Global
Impression of RSV Severity PGI‑S Scale
Score 		 From initiation of study treatment up to Day
35 
Time to Return to Pre-existing Health
Status for all RSV Symptoms as Assessed
by RiiQ Symptom Scale Score 		 From initiation of study treatment up to Day 35 
Time to Improvement in RSV Disease as
Assessed by Patient Global Impression of
Change PGI C Scale Score 		 From initiation of study treatment up to Day
35 
Change from Baseline Over Time for the
Health-Related Quality of Life (HRQOL) as
Assessed by 5 Level EuroQol 5 Dimension
EQ-5D-5L 		 Baseline up to Day 35 
Change from Baseline Over Time for the
RiiQ Impact Scales 		 Baseline up to Day 35 
Time to Return to Usual Health as
Assessed by the Adult RSV Return to
Usual Health Question 		 From initiation of study treatment up to Day
35 
Time to Return to Usual Activities as
Assessed by the Adult RSV Return to
Usual Activities Question 		 From initiation of study treatment up to Day
35 
Time to No or Mild Impact of RSV-related
Disease on Daily Activities, Emotions, and
Social Relationships as Assessed by RiiQ
Impact Scales 		 From initiation of study treatment up to Day
35 
RSV Viral Load Area Under the Curve
(AUC) from Immediately Prior to First Dose
of Study Intervention Baseline Through
Days 3 5 and 8 		 Baseline, Days 3 5 and 8 
Change from Baseline over Time in RSV
Viral Load 		 Baseline up to Day 21 
Percentage of Participants with
Undetectable RSV Viral Load 		 From initiation of study treatment up to Day
21 
Percentage of Participants with Postbaseline
Sequence Changes in the RSV F
Gene 		 From initiation of study treatment up to Day
21 
Predose Plasma Concentration (Ctrough) of
Rilematovir 		 Days 1 3 and 8 
Maximum Plasma Concentration (Cmax) of
Rilematovir 		 Days 1, 3 and 8 
Area Under the Curve of Administration of
Rilematovir up to 12 hours Post Dosing
(AUC[0-12h]) 		 Days 1, 3 and 8 
Percentage of Participants with Number
and Type of Medical Encounters 		 From initiation of study treatment up to Day
35 
Percentage of Participants with Shift in any
Care Setting 		 From initiation of study treatment up to Day
35 
Percentage of Participants Requiring
Hospitalization for Respiratory or Other
Reasons 		 From initiation of study treatment up to Day
35 
Duration of Hospitalization  From initiation of study treatment up to Day
35 
Percentage of Participants with Treatmentemergent
Use of Antibiotics 		 From initiation of study treatment up to Day
35 
Duration of Treatment-emergent Use of
Antibiotics 		 From initiation of study treatment up to Day
35 
Percentage of Participants with Treatmentemergent
New Use or Increased Dose of
Systemic or Inhaled Corticosteroids and
Bronchodilators 		 From initiation of study treatment up to Day
35 
Duration of Treatment-emergent New Use
or Increased Dose of Systemic or Inhaled
Corticosteroids and Bronchodilators 		 From initiation of study treatment up to Day
35 
Percentage of Participants with New or
Increased Use of Oxygen Therapy 		 From initiation of study treatment up to Day
35 
Duration of Oxygen Supplementation  From initiation of study treatment up to Day
35 
Duration of Selected Post-baseline
Emergent (After Start of Study Intervention)
Medical Resource Utilization 		 From initiation of study treatment up to Day
35 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="18" 
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 2 
Date of First Enrollment (India)   31/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  18/11/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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 this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 [depending on timing of first dose]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.
 
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