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New drug aims to tame severe viral lung infections

NCT ID NCT07633288

Disease control Sponsor: SynAct Pharma Aps Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Updated 2 times

Summary

This study tests whether a daily pill called AP1189 can help hospitalized patients with breathing failure due to viruses like flu, RSV, or COVID-19. About 96 adults will receive either AP1189 or a placebo for 14 days, on top of usual care. The main goal is to see if the drug reduces serious outcomes like death, need for a breathing machine, or kidney failure within 28 days.

What this could mean

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

Active substance
AP1189 (a melanocortin agonist pill)
What this could lead to
If it works, this could point toward a new add-on treatment to reduce severe complications from respiratory viral infections like flu, RSV, or COVID-19.
What could go wrong
This is an early Phase 2 proof-of-concept trial with only 96 participants, so results may not apply broadly. The drug is tested on top of standard care, and its benefit over placebo is uncertain.

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

About 96 people

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

Started

May 2026

Expected to finish

Aug 2027

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 years and older

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: * Written informed consent has been obtained prior to initiating any study-specific procedures * Expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV as confirmed by a bedside LAF test, qualitative PCR, or quantitative PCR (Q-PCR). * Hospitalized with respiratory insufficiency expected to be caused by respiratory viral infection defined by SpO2 ≤ 93 % on ambient air or supplementary oxygen supply via nasal catheter or facial mask (WHO Clinical Progression Scale score 5 or 6). Or in participants with hypercapnic respiratory failure (usually due to COPD) the SpO2 threshold is SpO2 ≤ 85 %. * Duration of disease from first symptom\< 15 days before enrolment * Females of childbearing potential using reliable means of contraception or are post-menopausal or are surgically sterilized * Females of childbearing potential with a negative pregnancy test at screening and baseline * As the morbidity and mortality of respiratory infections are many fold increased in vulnerable participants, vulnerable participants are not excluded but included as subgroups. * Screened within 24 hours of hospital admission to the hospital, or within 24 hours of receiving a patient, if the patient is transferred from another hospital or another hospital department due to respiratory distress Exclusion Criteria: * In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment * Already meeting any component of the primary composite endpoint at screening, defined as the presence of any of the following: invasive mechanical ventilation, ECMO, cardiovascular organ support (balloon pump or inotropes/vasopressors), or renal failure (Cockcroft-Gault estimated creatinine clearance \<15 ml/min, haemofiltration or dialysis). Note: participants qualifying under inclusion criterion 8b (pre-existing renal insufficiency or dialysis) are excluded only if they meet any of the other criteria (invasive mechanical ventilation, ECMO, or cardiovascular organ support). Participants who are physically located in an ICU or HDU but do not meet the above physiological criteria are not excluded on that basis alone. * Participating in other drug clinical trials * Any condition that in the view of the screening physician would suggest that the participant is unable to comply with study protocol and procedures * Participants who have initiated treatment within 3 months prior to screening with immunosuppressive or immunomodulatory treatments for chronic autoimmune diseases. Administration of steroids or other immunosuppressive medicines implemented as standard-of-care for the treatment of the respiratory viral infection is acceptable. Asthma/COPD participants are allowed to use their habitual inhalation spray containing adrenocortical hormone. * Pregnant women or nursing (breastfeeding) mothers

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Conditions

The condition(s) this trial relates to.

influenza viral respiratory tract infection

As listed by the trial registrant

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

Respiratory viral infection

How to take part

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

  1. The places running it

    11 sites in 4 countries. 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

  • Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital

    RECRUITING

    Auckland, 2025, New Zealand

  • Christchurch Hospital, 2 Riccarton Avenue,

    NOT_YET_RECRUITING

    Christchurch, 8011, New Zealand

  • Clinical Center of Montenegro, Clinic for Infectious Diseases

    RECRUITING

    Podgorica, Podgorica Municipality, 81000, Montenegro

  • Health Center Uzice, General Hospital Uzice

    RECRUITING

    Užice, Zlatibor District, 31000, Serbia

  • MRINZ, 7 CSB Building, Wellington Hospital

    RECRUITING

    Wellington, 6021, New Zealand

  • Te Toka Tumai Auckland, Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • University Clinical Center Republic of Srpska, Clinic for Infectious Diseases

    RECRUITING

    Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

  • University Clinical Centre Nis, Clinic for Infectious Diseases

    RECRUITING

    Niš, Nišava District, 18000, Serbia

  • University Clinical Centre Sarajevo, Clinic for Infectious Diseases

    RECRUITING

    Sarajevo, Sarajevo Canton, 71000, Bosnia and Herzegovina

  • University Clinical Centre of Serbia, Clinic for Infectious Diseases

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Hospital Mostar, Clinic for Infectious Diseases

    RECRUITING

    Mostar, Herzegovina-Neretva Canton, 88000, Bosnia and Herzegovina

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