A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai Ark Biopharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
Aged 18-85 years (inclusive), regardless of gender.
Diagnosed with RSV infection by antigen or nucleic acid test within 36 hours before first dose.
Have at least one of the following high-risk conditions for RSV infection: Chronic respiratory disease; heart disease; immunocompromised status; other chronic disease; age ≥65 years.
Presence of at least one new LRTD symptom or worsening of a pre-existing LRTD symptom (specifically: cough, expectoration, wheezing, shortness of breath), with at least one individual symptom rated as moderate or severe (score 2 or 3 per RiiQ Symptom Scale).
Disqualifiers
Diagnosed with influenza or COVID-19 infection within 7 days prior to providing informed consent.
Suspected bacterial co-infection.
Received any potentially anti-RSV agents (e.g., ribavirin, long-acting interferon) within 5 half-lives prior to the first study dose, or plans to use such agents during the study.
Received prohibited medications, or plans to use prohibited medications during the study.
Trial design
Treatments tested in this trial
- Ziresovir (AK0529)
- Placebo
Treatment groups
290 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov