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New oral pill aims to fight RSV in adults

NCT ID NCT03699202

Disease control Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 drug called AK0529 (Ziresovir) in adults aged 18 to 75 with respiratory syncytial virus (RSV) infection. Participants receive either the drug or a placebo, and researchers measure how well symptoms improve and track any side effects. The goal is to see if AK0529 can safely reduce RSV symptoms and viral load.

What this could mean

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

Active substance
AK0529 (Ziresovir)
What this could lead to
If successful, this could provide a new oral treatment option for adults with RSV infection, potentially reducing symptoms and viral load.
What could go wrong
This is an early phase 2 trial with a small number of participants, so results may not confirm effectiveness or safety. 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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Mar 2019

Finished

Apr 2019

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 75 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: * Age 18 - 75 years, inclusive. * Confirmed with RSV infection by rapid diagnostic testing. * New onset with documentation of the following symptoms within 72 hours prior to the start of screening: Respiratory symptoms: runny nose, stuffy nose, sneezing, sore throat, earache, cough, shortness of breath; Systemic symptoms: headache, fatigue / lethargy, fever, and muscle and / or joint ache. The patient must have four symptoms of above, and at least one of these must be respiratory symptom in nature. * Able and willing to provide written informed consent and to comply with the study protocol. Exclusion Criteria: * The patient has taken, is taking or needs to take any antiviral medication (e.g. ribavirin, Chinese medicine or herbs with effects of treating respiratory tract infection) within the 72 hours prior to screening. * Awareness of concomitant infections of respiratory viruses (eg, influenza A, B), bacterial or fungal infections, including systemic bacterial or fungal infections within 7 days prior to screening or during the screening period. * Patient frailty was evaluated as "Vulnerable" or worse according to the Clinical Frailty Scale with a score ≥ 4 at screening. * Awareness of having positive results on HBsAg or HCV antibody or HIV (HIV 1 or HIV 2). * Patient with active tuberculosis or is taking antituberculosis treatment. * Patient with severe gastrointestinal disease which could impact drug absorption, eg, vomiting, malabsorption syndrome, or short bowel syndrome caused by necrotizing enterocolitis. * Patient with any congenital heart disease, acute or chronic heart failure, ischemic heart disease, or congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation. * Patient with malignant tumor. * Patient has received or is waiting for bone marrow, stem cell or solid organ transplantation. * Patient with any immune-related disease to be treated within 12 months prior to screening. * Patient with clinical laboratoy test values of ≥ 2x the upper limit of normal (ULN) for alanine aminotransferase or aspartate aminotransferase, or \>1x ULN for total bilirubin, or \>1.5xULN for serum creatinine. * Patient with electrolyte disorders, eg, hypokalemia, hypocalcemia, or hypomagnesemia. * Patient with history of drug or alcohol abuse within 12 months prior to screening ("alcohol abuse" definition is \>14 units per week: 1 unit = 10mL Alcohol, or 250mL of 4% beer, or 25 mL of 40% spirit, or 75 mL of 13% wine). * Patient has allergy or hypersensitivity to study medication or its compositions. * Female patient with positive pregnancy test result or is lactating. * Patient with fertility refusing to use medically effective contraceptives during the study or within three months of the end of study. * Patient participated in an investigational drug or device study within 60 days prior to screening. * Patient who in the opinion of the investigator, is deemed as ineligible for the study, including patients who are with active psychiatric disease, or are taking psychiatric medication.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease

As listed by the trial registrant

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

Respiratory syncytial virus infections

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, 563000, China

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100029, China

  • Beijing Ditan Hospital

    Beijing, Beijing Municipality, 100015, China

  • Beijing Pinggu Hospital

    Beijing, 101200, China

  • Central Hospital of Minhang District, Shanghai

    Shanghai, 201199, China

  • China-Japan Friendship Hospital

    Beijing, 100029, China

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong, 516001, China

  • Jiangsu Taizhou People's Hospital

    Taizhou, Jiangsu, 225300, China

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006, China

  • Nantong First People's Hospital

    Nantong, 226001, China

  • People's Hospital of Deyang City

    Deyang, Sichuan, 618000, China

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011, China

  • Quanzhou First Hospital

    Quanzhou, Fujian, 362000, China

  • Sanya Central Hospital

    Sanya, Hainan, 572000, China

  • Shanghai East Hospital

    Shanghai, 200120, China

  • Shenzhen People's Hospital

    Shenzhen, 518001, China

  • Suining Central Hopital

    Suining, Sichuan, 629000, China

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004, China

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 571199, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000, China

  • Xiangtan Central Hospital

    Xiangtan, 411100, China

  • Xinxiang First People's Hospital

    Xinxiang, 453000, China

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