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

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06079320
Collaborator
(none)
2,715
Enrollment
2
Arms
21
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2715 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a Phase 2/ Phase 3, superiority, adaptive, two parallel-arm, randomized, multi-center, placebo-controlled, double-blind study.This is a Phase 2/ Phase 3, superiority, adaptive, two parallel-arm, randomized, multi-center, placebo-controlled, double-blind study.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 5, 2023
Anticipated Primary Completion Date :
Sep 5, 2025
Anticipated Study Completion Date :
Sep 5, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sisunatovir

Drug: Sisunatovir
Participants will receive tablets from Day 1 to Day 5
Placebo Comparator: Placebo

Drug: Placebo
Participants will receive matching placebo tablets from Day 1 to Day 5

Outcome Measures

Primary Outcome Measures

  1. 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 Measures

  1. Proportion of participants with RSV-related hospitalization or death from any cause through Day 28. [10 days and 28 days]

  2. Proportion of participants with Respiratory Syncytial Virus (RSV)-related visits or death from any cause through Day 28. [28 days]

  3. Proportion of participants with progression, development or resolution of Lower Respiratory Tract Infection (LRTI) through Day 10 [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT06079320
Other Study ID Numbers:
  • C5241007
  • 2023-505922-32-00
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Infections
Communicable Diseases
Virus Diseases
Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Oct 12, 2023