NCT07658534 A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.
| NCT ID | NCT07658534 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Ark Biopharmaceutical Co., Ltd. |
| Condition | Respiratory Syncytial Virus Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 290 participants in total. It began in 2026-03-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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). * Time from symptom onset (or worsening of pre-existing symptoms) to first dose ≤5 days. (Onset defined as time of first RSV-related symptom/sign confirmed by investigator; pre-existing symptoms are those due to underlying conditions) Exclusion Criteria: * 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. * Has a severe or unstable gastrointestinal, hepatic, renal, hematologic disorder, or malignancy. * Has a known allergy, hypersensitivity, or intolerance to AK0529 or to any excipients in the AK0529 or placebo formulation. * Female participants with a positive pregnancy test result, or who are breastfeeding. * Refusal to use effective contraception during the trial period.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07658534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Respiratory Syncytial Virus Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07658534 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07658534 currently recruiting?
Yes, NCT07658534 is actively recruiting participants. Contact the research team at chao.yu@arkbiosciences.com for enrollment information.
Where is the NCT07658534 trial being conducted?
This trial is being conducted at Beijing, China, Guangzhou, China, Cangzhou, China, Nanyang, China and 5 additional locations.
Who is sponsoring the NCT07658534 clinical trial?
NCT07658534 is sponsored by Shanghai Ark Biopharmaceutical Co., Ltd.. The trial plans to enroll 290 participants.