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A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection

Primary Purpose

Respiratory Syncytial Virus Infection

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sisunatovir
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Known history or has risk factors for QT prolongation or Torsades de Pointes or congenital deafness, family history of long QT syndrome or unexplained sudden death, or a standard 12-lead ECG with QTcF ≥450 ms Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Sisunatovir

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Proportion of participants with RSV-related hospitalization or death from any cause through Day 28.
    Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.
    Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10
    Proportion of participants with resolution of LRTI at Day 15.
    Mean number of days alive and free from hospital stay (hospital-free days) through Day 28.

    Full Information

    First Posted
    October 6, 2023
    Last Updated
    October 19, 2023
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06079320
    Brief Title
    A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection
    Official 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 NONHOSPITALIZED SYMPTOMATIC ADULTS WITH RESPIRATORY SYNCYTIAL VIRUS INFECTION WHO ARE AT RISK OF PROGRESSION TO SEVERE ILLNESS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 5, 2023 (Anticipated)
    Primary Completion Date
    September 5, 2025 (Anticipated)
    Study Completion Date
    September 5, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to learn about the safety and effects of sisunatovir. Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus (RSV). RSV is a virus that causes lung infections with cold-like symptoms, but it can cause severe illness in some people. Sisunatovir is studied in adults: who are not admitted to the hospital and who have high chances of having a severe illness from RSV infection. This study is seeking participants who: Are confirmed to have RSV. Have symptoms of a lung infection. Are 18 years of age or older. Have one or more of the following which increases the chances of RSV illness: A long-term lung disease. heart failure. a condition that weakens the immune system. Are 65 years of age or older and do not have any of the conditions above Half of the participants in this study will receive sisunatovir. The other half will receive a placebo for 5 days. Placebo looks same like the study medicine but does not have any medication. Both sisunatovir and placebo will be taken by mouth. The study will compare the experiences of people receiving sisunatovir to those of the people who do not. This will help decide if sisunatovir is safe and effective. Participants will attend about 8-10 study visits over 5 weeks. During this time, they will have: visits at the study clinic, blood work, swabs of the nose, questionnaires, a follow-up phone call.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Syncytial Virus Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a Phase 2/ Phase 3, superiority, adaptive, two parallel-arm, randomized, multi-center, placebo-controlled, double-blind study.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Participants will be assigned to receive study intervention according to the assigned treatment group from the randomization scheme. Investigators will remain blinded to each participant's assigned study intervention until all participants complete treatment.
    Allocation
    Randomized
    Enrollment
    2715 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sisunatovir
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Sisunatovir
    Intervention Description
    Participants will receive tablets from Day 1 to Day 5
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants will receive matching placebo tablets from Day 1 to Day 5
    Primary Outcome Measure Information:
    Title
    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
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Proportion of participants with RSV-related hospitalization or death from any cause through Day 28.
    Time Frame
    10 days and 28 days
    Title
    Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28.
    Time Frame
    28 days
    Title
    Proportion of participants with progression or development of Lower Respiratory Tract Infection (LRTI) through Day 10
    Time Frame
    10 days
    Title
    Proportion of participants with resolution of LRTI at Day 15.
    Time Frame
    15 days
    Title
    Mean number of days alive and free from hospital stay (hospital-free days) through Day 28.
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 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 Known history or has risk factors for QT prolongation or Torsades de Pointes or congenital deafness, family history of long QT syndrome or unexplained sudden death, or a standard 12-lead ECG with QTcF ≥450 ms Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pfizer CT.gov Call Center
    Phone
    1-800-718-1021
    Email
    ClinicalTrials.gov_Inquiries@pfizer.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.
    IPD Sharing URL
    https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
    Links:
    URL
    https://pmiform.com/clinical-trial-info-request?StudyID=C5241007
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection

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