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New treatment option for Respiratory Syncytial Virus Infections
Official title A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.
ClinicalTrials.gov ID: NCT07658534
What this study is testing
What is Ziresovir (AK0529)?
Ziresovir (AK0529) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for respiratory syncytial virus infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Presence of at least one new LRTD symptom or worsening of a pre-existing LRTD symptom (specifically: cough, expectoration, wheezing, shortness of...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Cangzhou, Hebei, China
- Nanyang, Henan, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Hangzhou, Zhejiang, China
- Rui’an, Zhejiang, China
- Taizhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Cangzhou, Hebei, China; Nanyang, Henan, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.