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New antiviral pill aims to shorten RSV symptoms in vulnerable adults

NCT ID NCT07658534

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an oral antiviral called ziresovir (AK0529) in adults at high risk for severe RSV infection, such as those with chronic lung or heart disease, weakened immune systems, or age 65 and older. Participants receive either the drug or a placebo, and researchers measure how quickly lower respiratory symptoms like cough, wheezing, and shortness of breath improve. The goal is to see if ziresovir can speed recovery and reduce the burden of RSV in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ziresovir (AK0529)
What this could lead to
If it works, this could provide a treatment to reduce severe RSV symptoms in vulnerable adults, potentially preventing hospitalizations.
What could go wrong
This is a mid-stage trial with 290 participants, so results may not confirm effectiveness. The drug may cause side effects or fail to outperform placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cangzhou Hospital of Integrated TCM-WM

    RECRUITING

    Cangzhou, Hebei, China

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Guangzhou Medical University Panyu Central Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

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

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • People's Hospital of Rui'an City

    RECRUITING

    Rui’an, Zhejiang, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, Zhejiang, China

  • The First Affiliated Hospital of Nanyang Medical College

    RECRUITING

    Nanyang, Henan, China

  • Wuhan Sixth Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Zhejiang Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, China

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