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 (RESPIRE)
27 juli 2026 uppdaterad av: SynAct Pharma Aps
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
96
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Thomas Jonassen, MD
- Telefonnummer: +45 4015 6669
- E-post: tj@synactpharma.com
Studieorter
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Herzegovina-Neretva Canton
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Mostar, Herzegovina-Neretva Canton, Bosnien och Hercegovina, 88000
- Rekrytering
- University Clinical Hospital Mostar, Clinic for Infectious Diseases
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Kontakt:
- Svjetlana Grgic, Prof. Dr.
- Telefonnummer: +38763317314
- E-post: svjetlanag@gmail.com
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Republika Srpska
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Banja Luka, Republika Srpska, Bosnien och Hercegovina, 78000
- Rekrytering
- University Clinical Center Republic of Srpska, Clinic for Infectious Diseases
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Kontakt:
- Antonija Verhaz, Prof. Dr.
- Telefonnummer: +38765649350
- E-post: antonija.verhaz@kc-bl.com
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Sarajevo Canton
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Sarajevo, Sarajevo Canton, Bosnien och Hercegovina, 71000
- Rekrytering
- University Clinical Centre Sarajevo, Clinic for Infectious Diseases
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Kontakt:
- Rusmir Baljic, Prof. Dr.
- Telefonnummer: +38761835166
- E-post: rusmir.ba@gmail.com
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Podgorica Municipality
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Podgorica, Podgorica Municipality, Montenegro, 81000
- Rekrytering
- Clinical Center of Montenegro, Clinic for Infectious Diseases
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Kontakt:
- Brankica Dupanovic, Dr.
- Telefonnummer: +38269426190
- E-post: dupanovicbrankica@gmail.com
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Auckland, Nya Zeeland, 1023
- Rekrytering
- Te Toka Tumai Auckland, Auckland City Hospital
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Kontakt:
- Tom Hills, Dr.
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Auckland, Nya Zeeland, 2025
- Rekrytering
- Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital
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Kontakt:
- Michael Borrie, Dr.
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Christchurch, Nya Zeeland, 8011
- Har inte rekryterat ännu
- Christchurch Hospital, 2 Riccarton Avenue,
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Kontakt:
- Seton Henderson, Dr.
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Wellington, Nya Zeeland, 6021
- Rekrytering
- MRINZ, 7 CSB Building, Wellington Hospital
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Kontakt:
- Max Bloomfield, Dr.
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Belgrade, Serbien, 11000
- Rekrytering
- University Clinical Centre of Serbia, Clinic for Infectious Diseases
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Kontakt:
- Goran Stevanovic, Prof. Dr.
- Telefonnummer: +3811126883366
- E-post: goran_drste@yahoo.com
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Nišava District
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Niš, Nišava District, Serbien, 18000
- Rekrytering
- University Clinical Centre Nis, Clinic for Infectious Diseases
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Kontakt:
- Marina Djordjevic-Spasic, Dr.
- Telefonnummer: +381654100940
- E-post: marina_djordjevic@yahoo.com
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Zlatibor District
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Užice, Zlatibor District, Serbien, 31000
- Rekrytering
- Health Center Uzice, General Hospital Uzice
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Kontakt:
- Zorica Radojevic, Dr.
- Telefonnummer: +31599599
- E-post: drradojevic@gmail.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: AP1189, 100 mg
AP1189 tablet for oral use
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14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment
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Experimentell: AP1189 matching placebo
AP1189 tablet for oral use
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14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: 28 days
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28 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2026
Primärt slutförande (Beräknad)
1 augusti 2027
Avslutad studie (Beräknad)
1 augusti 2027
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SynAct-CS009
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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