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Clinical Trials List

Protocol NumberC5241007

NCT Number(ClinicalTrials.gov Identfier)NCT06079320

Completed

2023-12-08 - 2024-09-30

Phase II/III

Recruiting7

Terminated1

ICD-10B97.4

Respiratory syncytial virus as the cause of diseases classified elsewhere

ICD-9079.6

Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site

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

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Ching-Tai Huang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chau-Chyun Sheu 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wang-Huei Sheng 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Po-Yu Liu 無

Taichung Veterans General Hospital

Co-Principal Investigator

曾建豪無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YI-TSUNG LIN 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hsing Liao 無

Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Kaohsiung Municipal Ta-Tung Hospital

Co-Principal Investigator

陳家閔 Division of Infectious Disease
Shang-Yi Lin Division of Infectious Disease
Wei-An Chang Division of Infectious Disease

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Respiratory Syncytial Virus Infection

Objectives

To investigate the safety and efficacy of oral sisunatovir, a potent inhibitor of the RSV F protein that blocks viral entry into host cells, for the treatment of RSV infection in non-hospitalized adults at risk for severe disease.

Test Drug

SisunatovirPlacebo

Active Ingredient

Sisunatovir
Placebo

Dosage Form

tablet
tablet

Dosage

100mg/tablet
0mg/tablet

Endpoints

‧ Proportion of participants with RSV-related hospitalization or death from any cause through day 28.

Inclution 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

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.

The Estimated Number of Participants

Taiwan

70 participants
Global

2375 participants