RecruitingPhase 2Phase 3NCT07658534

A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.

A Randomized, Double-blind, Two-stage, Placebo-controlled Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of Ziresovir (AK0529) in Adult Patients at High Risk for Respiratory Syncytial Virus (RSV) Infection.


Sponsor

Shanghai Ark Biopharmaceutical Co., Ltd.

Enrollment

290 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia, and affect the cardiovascular system, central nervous system and the renal system, resulting in hospitalization and death risks in children and also high-risk adults, particularly the elderly. The purpose of this study is to evaluate the efficacy of Ziresovir (AK0529) compared to placebo with respect to the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Ziresovir (AK0529) for people with respiratory syncytial virus infections. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZiresovir (AK0529)

Active Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral

DRUGPlacebo

Active Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral


Locations(9)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Guangzhou Medical University Panyu Central Hospital

Guangzhou, Guangdong, China

Cangzhou Hospital of Integrated TCM-WM

Cangzhou, Hebei, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Henan Infectious Disease Hospital (The Sixth People's Hospital of Zhengzhou)

Zhengzhou, Henan, China

Wuhan Sixth Hospital

Wuhan, Hubei, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

People's Hospital of Rui'an City

Rui’an, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07658534


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