A study to determine if the study medicine called Sisunatovir is safe and prevents severe illness in adults with Respiratory Syncytial Virus infection.
Scientific Title of Study
An interventional phase 2/3, adaptive, multi-Center, randomized, double-blind study to investigate efficacy and safety of oral Sisunatovir compared with Placebo in non-hospitalized symptomatic adults with Respiratory Syncytial Virus infection who are at risk of progression to severe illness.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
2023-505922-32-00
EudraCT
NCT06079320
ClinicalTrials.gov
Protocol No.: C5241007 Final Protocol dated 01-Sep-2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Seema Pai
Designation
Director-Clinical Site Operations
Affiliation
Pfizer Limited
Address
Global Site and Study Operations, Clinical Development andOperations, Global Product Development, Pfizer Limited, TheCapital, 1802/1901, Plot No. C70, G Block, Bandra KurlaComplex, Bandra(E)
Mumbai MAHARASHTRA 400051 India
Phone
8826422322
Fax
Email
seema.pai@pfizer.com
Details of Contact Person Public Query
Name
Dr Seema Pai
Designation
Director-Clinical Site Operations
Affiliation
Pfizer Limited
Address
Global Site and Study Operations, Clinical Development andOperations, Global Product Development, Pfizer Limited, TheCapital, 1802/1901, Plot No. C70, G Block, Bandra KurlaComplex, Bandra(E)
Mumbai MAHARASHTRA 400051 India
Phone
8826422322
Fax
Email
seema.pai@pfizer.com
Source of Monetary or Material Support
Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001
Primary Sponsor
Name
Pfizer Inc.
Address
66 Hudson Boulevard East, New York, NY 10001
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Ms Pfizer Limited
The Capital, 1802/1901, Plot No. C-70 G Block, Bandra Kurla Complex, Bandra (E), Mumbai City (India) - 400051.
Countries of Recruitment
Argentina Australia Brazil Bulgaria Canada China Czech Republic Democratic People's Republic of Korea Germany India Italy Japan Mexico Poland Slovakia South Africa Spain Taiwan Turkey United Kingdom United States of America
Sites of Study
No of Sites = 11
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Akshay Budhraja
Aakash healthcare Private Limited
Sleep and Respiratory Medicine, 14, Ground floor, Hospital Plot, Road No. 201 Sector-3 Dwarka South West DELHI
9893322007
drakshay.budhraja@aakashhealthcare.com
Dr Mohan M E
BGS Global Institute of Medical Sciences (BGSGIMS)
General medicine, Room no-31, OPD, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Ground Floor Bangalore KARNATAKA
9900126444
drmohanbgsresearch@gmail.com
Dr Anjan Talukdar
Gauhati Medical College and Hospital,
Department of Internal medicine, Narakasur Hilltop, Bhangagarh, Guwahati-781032, Assam, India. Kamrup ASSAM
9954658926
anjan110178@gmail.com
Dr Sanjiv Maheshwari
Jawahar Lal Nehru Medical College
109, Medicine department, Kala Bagh Ajmer RAJASTHAN
9460479888
doctorsanjiv@gmail.com
Dr Manish Jain
Maharaja Agrasen Superspeciality Hospital
Pulmonary Medicine, B 11,Agrasen Aspatal Marg, Central Spine, Sec. 7 Jaipur RAJASTHAN
9414414834
doctormanishjain2@gmail.com
Dr Anand Jaiswal
Medanta-The Medicity
Medanta Research Department 10th Floor A wing POCU Room no 1 & 2 Medanta Department of Respiratory and Sleep medicine Sector 38 Gurgaon HARYANA
9818767185
anand.jaiswal@medanta.org
Dr Gaurish Gadbail
Nirmal Hospital
Nirmal hospital Pvt Ltd, Ring Road Surat GUJARAT
9979530073
dr.gaurishgadbail@gmail.com
Dr Indranath Ghosh
North Bengal Medical College
Department of Chest Medicine, 244, AJC Bose Road, D-5 Quarter, Sushruta Nagar, Darjeeling Kolkata WEST BENGAL
9836835957
drindranath_77@yahoo.com
Dr Badal Kumar Sahu
NRS Medical College and Hospital
Department of Medicine, Room no. 8, 138, AJC Bose Road Kolkata WEST BENGAL
8240184543
drbadal08@gmail.com
Dr Vivek Gundappa
Radhakrishna Multi Specialty Hospital and IVF Center
Department of Pulmonology, 4th Floor, Consultation Room, 3 and 4 Sunrise Tower, JP Road, Opposite Canara Bank, Giri Nagar Bangalore KARNATAKA
9739701000
vivek.g27@gmail.com
Dr Jagdish Kumar Rawat
Shri Guru Ram Rai Institute of Medical and Health Sciences and Shri Mahant Indiresh Hospital
4th Floor, South Block, Department of Respiratory, Patel Nagar, Dehradun – 248001, Uttarakhand, India. Dehradun UTTARANCHAL
9639212630
drjagdishrawat@gmail.com
Details of Ethics Committee
No of Ethics Committees= 11
Name of Committee
Approval Status
Aakash Healthcare Super Speciality Hospital Institutional Ethics Committee, Hospital Plot, Road No. 201 Sector 3 Dwarka New Delhi
Approved
BGS Global Institute of Medical Sciences, Institutional Ethics Committee, Department of Community medicine, Room no.01, Second floor college building, 67, BGS Health and Education city, Uttarahalli Road, Kengeri, Bangalore
Approved
BGS Global Institute of Medical Sciences, Institutional Ethics Committee, Department of Community medicine, Room no.01, Second floor college building, 67, BGS Health and Education city, Uttarahalli Road, Kengeri, Bangalore
Approved
GOVERNMENT OF ASSAM, Office of the Principal-cum-Chief Superintendent, Institution Ethics Committee, Gauhati Medical College and Hospital, Narakasur Hilltop, Bhangagarh, Guwahati-781032, Assam
Institution Ethics Committee, Administrative Block, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun – 248001, Uttarakhand
Submittted/Under Review
Institutional Ethics Committee for Human Research Medical College, Kolkata Medical College , Kolkata 88, College Street Kolkata, West Bengal
Submittted/Under Review
INSTITUTIONAL ETHICS COMMITTEE North Bengal Medical College And Hospital North Bengal Medical College, Susrutanagar Siliguri, Darjeeling
Submittted/Under Review
Institutional Ethics Committee, Jawahar Lal Nehru Medical College Kala Bagh, Ajmer, Rajasthan
Participants will receive 2 matching placebo tablets q12h from Day 1 to Day 5 (10 doses).
The total study duration for each participant is up to 5 weeks and includes a screening period of 1-2 days where Day 1 of study intervention must start by the second consecutive day, study intervention administration through Day 5, efficacy outcome assessments through Day 28, and a safety follow-up period through Day 35.
Intervention
Sisunatovir (PF-07923568)
Participants will receive 2 tablets of 100 mg of sisunatovir q12h from Day 1 to Day 5 (10 doses)
The total study duration for each participant is up to 5 weeks and includes a screening period of 1-2 days where Day 1 of study intervention must start by the second consecutive day, study intervention administration through Day 5, efficacy outcome assessments through Day 28, and a safety follow-up period through Day 35.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
(1) Participants aged 18 years or older at screening.
(2) Diagnosis of RSV infection collected within 5 days prior to randomization.
(3) New onset or worsening (if present chronically) of at least one of the following signs and/or symptoms consistent with a viral acute respiratory infection (ARI), within 5 days prior to randomization: nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.
(4) Has at least 1 of the following characteristics or underlying medical conditions: a) 65 years of age or older b) Chronic lung disease, c) Heart failure, d) Immunosuppressive disease/condition or immune-weakening medications
ExclusionCriteria
Details
1. Any medical (eg, confirmed concurrent active systemic infection other than RSV
including bacterial, fungal, or viral) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study or interfere with the evaluation of response to the study intervention.
2. Diagnosis of viral respiratory infections other than RSV including influenza and SARSCoV-2, within 7 days prior to randomization. A negative test for SARS-CoV-2 and
influenza is required within 7 days prior to randomization.
3. Current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization in the clinical opinion of the site investigator.
4. Known history or has risk factors for QT prolongation or Torsades de Pointes (eg,
organic heart disease, hypokalemia, hypomagnesaemia, congenital long QT syndrome) or
congenital deafness, family history of long QT syndrome or unexplained sudden death
OR a standard 12-lead ECG with QTcF ≥450 ms.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of participants with Respiratory Syncytial Virus (RSV)-related hospitalization or death from any cause through Day 28, among patients treated ≤3 days after RSV symptom onset
28 days
Secondary Outcome
Outcome
TimePoints
Proportion of participants with RSV-related hospitalization or death from any cause through Day 28.
10 days & 28 days
Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.days
28
Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10
10 days
Proportion of participants with resolution of LRTI at Day 15
15 days
Mean number of days alive & free from hospital stay (hospital-free days) through Day 28.
28 days
Target Sample Size
Total Sample Size="4075" Sample Size from India="200" 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/ Phase 3
Date of First Enrollment (India)
19/07/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
05/12/2023
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="1" Days="5"
Recruitment Status of Trial (Global)
Other (Terminated)
Recruitment Status of Trial (India)
Other (Terminated)
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Respiratory syncytial
virus (RSV) is a worldwide cause of respiratory infection that causes
significant morbidity and mortality among vulnerable patients (young
children, immunocompromised, cardiopulmonary comorbidities, and elderly). The
virus is highly infectious and transmitted through respiratory secretions via
close contact with infected individuals, droplets, or contaminated surfaces.
The virus circulates during the colder months, resulting in geographically
specific RSV seasons. The 2 major subtypes of RSV (A and B) cause similar
disease and can co-circulate.
Older adults and individuals affected
by cardiopulmonary comorbidities or compromised immune system are at
increased risk of poor clinical outcomes following respiratory syncytial
virus (RSV) infection. Currently, no oral treatment is approved for this
indication.
The purpose of this trial is to
investigate the safety and efficacy of orally administered sisunatovir, a
potent inhibitor of the RSV F protein that prevents entry into the host
cells, for the treatment of RSV infection in non-hospitalized adults at risk
of severe illness.
All objectives, endpoints, and estimands will be
evaluated in non-hospitalized adults who are infected with RSV and are at high
risk of severe illness. The treatment effect is evaluated in the population of
study participants who are randomized and treated irrespective of their compliance
to the planned course of treatment or use of concomitant medications. The primary
analysis is restricted to adults treated ≤3 days after RSV symptom onset. All
key secondary endpoints are analyzed regardless of duration from RSV symptom
onset to initiation of treatment.