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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06079320




Registration number
NCT06079320
Ethics application status
Date submitted
6/10/2023
Date registered
12/10/2023

Titles & IDs
Public title
A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection
Scientific title
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
Secondary ID [1] 0 0
2023-505922-32-01
Secondary ID [2] 0 0
C5241007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sisunatovir
Treatment: Drugs - Placebo

Experimental: Sisunatovir -

Placebo comparator: Placebo -


Treatment: Drugs: Sisunatovir
Participants will receive tablets from Day 1 to Day 5

Treatment: Drugs: Placebo
Participants will receive matching placebo tablets from Day 1 to Day 5
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Respiratory Syncytial Virus (RSV)-related hospitalization or death from any cause through Day 28
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10
Timepoint [2] 0 0
10 days
Secondary outcome [3] 0 0
Proportion of participants with resolution of LRTI at Day 15.
Timepoint [3] 0 0
15 days
Secondary outcome [4] 0 0
Mean number of days alive and free from hospital stay (hospital-free days) through Day 28.
Timepoint [4] 0 0
28 days

Eligibility
Key inclusion criteria
* Participants aged 18 years or older at screening.
* Diagnosis of RSV infection collected within 5 days prior to randomization.
* 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.
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any medical or psychiatric condition 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.
* Diagnosis of viral respiratory infections other than RSV including influenza and SARS-CoV-2
* Current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization
* Any clinically significant ECG abnormality in the pre-dose ECG that, per investigator judgement, may affect participant safety
* Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2024
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [2] 0 0
AusTrials - St. Leonards - St Leonards
Recruitment hospital [3] 0 0
AusTrials - Taringa - Taringa
Recruitment hospital [4] 0 0
Adrian Costa Clinical Trials Centre - Geelong
Recruitment hospital [5] 0 0
Barwon Health - Geelong
Recruitment hospital [6] 0 0
AusTrials - Sunshine - Melbourne
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4068 - Taringa
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3021 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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Illinois
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Montana
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma DE Buenos Aires
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Canada
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British Columbia
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Canada
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Ontario
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China
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Anhui
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China
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Beijing
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China
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Guangdong
Country [35] 0 0
China
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Guangxi Zhuang Autonomous Regin
Country [36] 0 0
China
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Guangxi Zhuang Autonomous Region
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China
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Guangxi
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangxi
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China
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Shanghai
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China
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Guangzhou
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China
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Hangzhou
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India
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Delhi
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India
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Gujarat
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India
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Karnataka
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India
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Rajasthan
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India
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Uttarakhand
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Miyazaki
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Japan
State/province [64] 0 0
Okayama
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South Africa
State/province [65] 0 0
FREE State
Country [66] 0 0
South Africa
State/province [66] 0 0
Gauteng
Country [67] 0 0
South Africa
State/province [67] 0 0
Kwazulu-natal
Country [68] 0 0
South Africa
State/province [68] 0 0
Limpopo
Country [69] 0 0
South Africa
State/province [69] 0 0
Mpumalanga
Country [70] 0 0
Taiwan
State/province [70] 0 0
Kaohsiung
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06079320