Ziresovir (AK0529) for high-risk adults with RSV infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2/3 trial evaluates the efficacy of Ziresovir (AK0529) versus placebo in adults aged 18 to 85 with confirmed RSV infection and at least one high-risk condition. Eligible participants must have new or worsening lower respiratory tract symptoms and begin treatment within 5 days of symptom onset or worsening. The primary outcome focuses on time to resolution of RSV LRTD symptoms, with safety monitoring throughout the study. Conducted across hospitals in China, the trial uses randomization and blinded placebo control to assess antiviral effect in a real-world high-risk population.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cangzhou Hospital of Integrated TCM-WM
  Cangzhou, Hebei, China Recruiting
• The First Affiliated Hospital of Nanyang Medical College
  Nanyang, Henan, China Recruiting
• Wuhan Sixth Hospital
  Wuhan, Hubei, China Recruiting
• People's Hospital of Rui'an City
  Rui’an, Zhejiang, China Recruiting
• Taizhou Hospital of Zhejiang Province
  Taizhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Chao Yu, Mater
• Email: chao.yu@arkbiosciences.com
• Phone: +86 021-50681677

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Recombinant RSV Vaccine (CHO Cell) with Adjuvant in Adults 18+ in China

  This is a two-part study testing a recombinant RSV vaccine in adults to see if it is safe and whether it provokes an immune response, with older adults (60+) included in the second part.

  Recruiting Phase 1/2 Ab&B Bio-tech Co., Ltd.JS · Zigong, Sichuan · NCT07582796

• RSV strains and illness burden in Vietnamese adults aged 60 and older

  This project will test how common RSV is and which strains and severity patterns occur in people aged 60+ who are hospitalized with acute respiratory illness or worsening heart/lung disease.

  Recruiting Tam Anh Research Institute · Ho Chi Minh City, Southern Vietnam · NCT07239583

• S-337395 for high-risk adults with symptomatic RSV

  This trial will test whether taking the antiviral S-337395 within 72 hours of symptoms helps nonhospitalized adults with RSV who are at high risk of progressing to severe illness.

  Recruiting at 88 sites Phase 2 Shionogi Inc. · Los Angeles, California and 88 other locations · NCT07214571

• Evaluating a new treatment to prevent severe COVID-19 complications

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  Recruiting at 3 sites Phase 1/2 Peaches Biotech · Alcalá de Henares, Madrid and 2 other locations · NCT06684379

• Inhaled interferon α1b treatment for RSV in young children

  This study is testing a new inhaled treatment for RSV in young children under 2 years old to see if it helps them get better and is safe to use.

  Recruiting Phase 3 Kexing Biopharm Co., Ltd. · Beijing, Beijing Municipality · NCT06363370

• Identifying biomarkers linked to severity in adults with RSV infections

  This study is trying to find specific markers in the body that can help doctors understand how severe Respiratory Syncytial Virus (RSV) infections are in adults who are hospitalized.

  Recruiting Assistance Publique - Hôpitaux de Paris · Créteil · NCT06197152

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.