New antiviral pill aims to shorten RSV symptoms in vulnerable adults
NCT ID NCT07658534
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cangzhou Hospital of Integrated TCM-WM
RECRUITINGCangzhou, Hebei, China
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China-Japan Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Guangzhou Medical University Panyu Central Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Henan Infectious Disease Hospital (The Sixth People's Hospital of Zhengzhou)
NOT_YET_RECRUITINGZhengzhou, Henan, China
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People's Hospital of Rui'an City
RECRUITINGRui’an, Zhejiang, China
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Taizhou Hospital of Zhejiang Province
RECRUITINGTaizhou, Zhejiang, China
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The First Affiliated Hospital of Nanyang Medical College
RECRUITINGNanyang, Henan, China
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Wuhan Sixth Hospital
RECRUITINGWuhan, Hubei, China
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Zhejiang Hospital
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- When the immune system Can't fight back: tracking three respiratory viruses
- A 5-Minute ultrasound could reveal how sick a Baby's lungs really are
- Nasal spray vaccine aims to shield children from RSV
- Inhaled interferon could be new weapon against severe RSV in young children
- New oral pill aims to fight RSV in adults
- New rapid test could spot flu and RSV in minutes at your local clinic