Respiratory Viral InfectionPhase 2RESPIRENCT07633288
A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses
A Phase 2 study testing AP1189, 100 mg in people with Respiratory Viral Infection, run by SynAct Pharma Aps at 11 sites in 4 countries.
Trial summary
A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Viral Infection
- What is being tested?
- AP1189, 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 1 May 2026to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 4 countries
New Zealand4 sites, 4 recruiting
- Recruiting
Te Toka Tumai Auckland, Auckland City Hospital
Auckland, 1023
Tom Hills, Dr.
- Recruiting
Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
Auckland, 2025
Michael Borrie, Dr.
- Not yet recruiting
Christchurch Hospital, 2 Riccarton Avenue,
Christchurch, 8011
Seton Henderson, Dr.
- Recruiting
MRINZ, 7 CSB Building, Wellington Hospital
Wellington, 6021
Max Bloomfield, Dr.
Bosnia and Herzegovina3 sites, 3 recruiting
- Recruiting
University Clinical Center Republic of Srpska, Clinic for Infectious Diseases
Banja Luka, Republika Srpska, 78000
Antonija Verhaz, Prof. Dr., +38765649350, antonija.verhaz@kc-bl.com
- Recruiting
University Clinical Hospital Mostar, Clinic for Infectious Diseases
Mostar, Herzegovina-Neretva Canton, 88000
Svjetlana Grgic, Prof. Dr., +38763317314, svjetlanag@gmail.com
- Recruiting
University Clinical Centre Sarajevo, Clinic for Infectious Diseases
Sarajevo, Sarajevo Canton, 71000
Rusmir Baljic, Prof. Dr., +38761835166, rusmir.ba@gmail.com
Serbia3 sites, 3 recruiting
- Recruiting
University Clinical Centre of Serbia, Clinic for Infectious Diseases
Belgrade, 11000
Goran Stevanovic, Prof. Dr., +3811126883366, goran_drste@yahoo.com
- Recruiting
University Clinical Centre Nis, Clinic for Infectious Diseases
Niš, Nišava District, 18000
Marina Djordjevic-Spasic, Dr., +381654100940, marina_djordjevic@yahoo.com
- Recruiting
Health Center Uzice, General Hospital Uzice
Užice, Zlatibor District, 31000
Zorica Radojevic, Dr., +31599599, drradojevic@gmail.com
Montenegro1 site, 1 recruiting
- Recruiting
Clinical Center of Montenegro, Clinic for Infectious Diseases
Podgorica, Podgorica Municipality, 81000
Brankica Dupanovic, Dr., +38269426190, dupanovicbrankica@gmail.com
About this study
Official title: A Randomized, Double-blind, Multicentre, Placebo-controlled, Proof-of-concept Clinical Trial Evaluating the Safety and Efficacy of the Biased Melanocortin Agonist AP1189 Versus Placebo as an add-on to Standard of Care (SOC) in Participants With RESPIRatory Insufficiency Expected to be Caused by Infection With Respiratory Viruses, Including Influenza, Respiratory Syncytial Virus, and Coronavirus
A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.
Read the detailed description
The purpose of the trial is to evaluate the efficacy and safety 14 days daily treatment of oral AP1189 at a dose or 100 mg as an add-on to SOC treatment.
The aim is to have 96 participants randomized and completing the study. They will be randomized in a 1:1 ratio to one of the following two groups:
- Group A (48 participants): AP1189 tablets 100 mg, once daily for 14 days as an add-on to SOC
- Group B (48 participants): placebo tablets once daily for 14 days as an add-on to SOC.
- Conditions
- Respiratory Viral Infection
- Being tested
- AP1189, 100 mg, Placebo
- Keywords
- Influenza, Respiratory Syncytial virus,, Corona virus
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP1189, 100 mgDrug
14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
PlaceboDrug
14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment
| Study group | Role | What they receive |
|---|---|---|
| AP1189, 100 mg | Experimental | AP1189 tablet for oral use Receives: Drug: AP1189, 100 mg |
| AP1189 matching placebo | Experimental | AP1189 tablet for oral use Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants meeting the composite endpoint, consisting of either death, invasive mechanical ventilation, ECMO, cardiovascular organ support, new occurrences of renal failure, hemofiltration or dialysis from baseline to day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 May 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SynAct Pharma Aps
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633288
- Sponsor's protocol ID
- SynAct-CS009
- Acronym
- RESPIRE
- Status last verified
- Jul 2026
- First submitted
- 2 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicentre, Placebo-controlled, Proof-of-concept Clinical Trial Evaluating the Safety and Efficacy of the Biased Melanocortin Agonist AP1189 Versus Placebo as an add-on to Standard of Care (SOC) in Participants With RESPIRatory Insufficiency Expected to be Caused by Infection With Respiratory Viruses, Including Influenza, Respiratory Syncytial Virus, and Coronavirus
- ClinicalTrials.gov ID
- NCT07633288
- Acronym / sponsor ID
- RESPIRE / SynAct-CS009
- Conditions
- Respiratory Viral Infection
- Keywords
- Influenza, Respiratory Syncytial virus,, Corona virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- SynAct Pharma ApsIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.
Detailed description
The purpose of the trial is to evaluate the efficacy and safety 14 days daily treatment of oral AP1189 at a dose or 100 mg as an add-on to SOC treatment.
The aim is to have 96 participants randomized and completing the study. They will be randomized in a 1:1 ratio to one of the following two groups:
- Group A (48 participants): AP1189 tablets 100 mg, once daily for 14 days as an add-on to SOC
- Group B (48 participants): placebo tablets once daily for 14 days as an add-on to SOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP1189, 100 mg | Experimental | Drug: AP1189, 100 mgAP1189 tablet for oral use |
| AP1189 matching placebo | Experimental | Drug: PlaceboAP1189 tablet for oral use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP1189, 100 mg14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment | Drug | AP1189, 100 mg |
| Placebo14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment | Drug | AP1189 matching placebo |
Primary outcome
Number of participants meeting the composite endpoint, consisting of either death, invasive mechanical ventilation, ECMO, cardiovascular organ support, new occurrences of renal failure, hemofiltration or dialysis from baseline to day 28
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP1189, 100 mg in people with Respiratory Viral Infection, run by SynAct Pharma Aps at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in New Zealand, Bosnia and Herzegovina, Serbia, Montenegro. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Jonassen, MD (+45 4015 6669, tj@synactpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants meeting the composite endpoint, consisting of either death, invasive mechanical ventilation, ECMO, cardiovascular organ support, new occurrences of renal failure, hemofiltration or dialysis from baseline to day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.