A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.
Condition(s) studied
Investigational drug(s) / intervention(s)
Ziresovir (AK0529): Active Substance: AK0529 Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
Placebo: Active Substance: Placebo Pharmaceutical Form: Enteric Capsules Route of Administration: Oral
Study 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
Primary outcome measure(s)
- Time from first dose to resolution of LRTD symptoms — Up to Day 27
LRTD symptoms (cough, shortness of breath, wheezing, expectoration) are assessed by the RiiQ symptom scale, which includes 13 symptoms: 2 upper respiratory (stuffy nose, sore throat), 4 lower respiratory (cough, expectoration, wheezing, shortness of breath), and 7 systemic (feeling feverish, headache, body aches/pains, neck pain, trouble sleeping, tiredness, poor appetite). Each symptom is scored as None (0), Mild (1), Moderate (2), or Severe (3), with a total score range of 0-39.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | Recruiting |
| Guangzhou Medical University Panyu Central Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Cangzhou Hospital of Integrated TCM-WM | Cangzhou | Hebei | Recruiting |
| The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan | Recruiting |
| Henan Infectious Disease Hospital (The Sixth People's Hospital of Zhengzhou) | Zhengzhou | Henan | Not Yet Recruiting |
| Wuhan Sixth Hospital | Wuhan | Hubei | Recruiting |
| Zhejiang Hospital | Hangzhou | Zhejiang | Not Yet Recruiting |
| People's Hospital of Rui'an City | Rui’an | Zhejiang | Recruiting |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | Recruiting |
More Shanghai Ark Biopharmaceutical Co., Ltd. trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07658534 on ClinicalTrials.gov ↗ ← All trials in Japan