[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643581":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":195,"collaborators":23,"id":197,"slug":198,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":23,"enrollmentInfo":207,"targetDuration":23,"studyType":210,"phases":211,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":37,"whyStopped":23,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},{"fullName":5,"class":6},"SynAct Pharma Aps","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AP1189, 100 mg","EXPERIMENTAL","AP1189 tablet for oral use",[13],"Drug: AP1189, 100 mg",{"label":15,"type":10,"description":11,"interventionNames":16},"AP1189 matching placebo",[17],"Drug: Placebo",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment",[9],null,{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Placebo","14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Thomas Jonassen, MD","CONTACT","+45 4015 6669","tj@synactpharma.com",[35,54,69,84,101,116,125,137,149,166,181],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University Clinical Hospital Mostar, Clinic for Infectious Diseases","RECRUITING","Mostar","Herzegovina-Neretva Canton","88000","Bosnia and Herzegovina","BA",{"type":44,"coordinates":45},"Point",[46,47],17.80806,43.34333,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":23,"email":53},"Svjetlana Grgic, Prof. Dr.","+38763317314","svjetlanag@gmail.com",{"facility":55,"status":37,"city":56,"state":57,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"University Clinical Center Republic of Srpska, Clinic for Infectious Diseases","Banja Luka","Republika Srpska","78000",{"type":44,"coordinates":60},[61,62],17.20629,44.77879,{"lat":62,"lon":61},[65],{"name":66,"role":31,"phone":67,"phoneExt":23,"email":68},"Antonija Verhaz, Prof. Dr.","+38765649350","antonija.verhaz@kc-bl.com",{"facility":70,"status":37,"city":71,"state":72,"zip":73,"country":41,"countryCode":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University Clinical Centre Sarajevo, Clinic for Infectious Diseases","Sarajevo","Sarajevo Canton","71000",{"type":44,"coordinates":75},[76,77],18.35644,43.84864,{"lat":77,"lon":76},[80],{"name":81,"role":31,"phone":82,"phoneExt":23,"email":83},"Rusmir Baljic, Prof. Dr.","+38761835166","rusmir.ba@gmail.com",{"facility":85,"status":37,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Clinical Center of Montenegro, Clinic for Infectious Diseases","Podgorica","Podgorica Municipality","81000","Montenegro","ME",{"type":44,"coordinates":92},[93,94],19.26309,42.44124,{"lat":94,"lon":93},[97],{"name":98,"role":31,"phone":99,"phoneExt":23,"email":100},"Brankica Dupanovic, Dr.","+38269426190","dupanovicbrankica@gmail.com",{"facility":102,"status":103,"city":104,"state":23,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Te Toka Tumai Auckland, Auckland City Hospital","NOT_YET_RECRUITING","Auckland","1023","New Zealand","NZ",{"type":44,"coordinates":109},[110,111],174.76349,-36.84853,{"lat":111,"lon":110},[114],{"name":115,"role":31,"phone":23,"phoneExt":23,"email":23},"Tom Hills, Dr.",{"facility":117,"status":103,"city":104,"state":23,"zip":118,"country":106,"countryCode":107,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital","2025",{"type":44,"coordinates":120},[110,111],{"lat":111,"lon":110},[123],{"name":124,"role":31,"phone":23,"phoneExt":23,"email":23},"Michael Borrie, Dr.",{"facility":126,"status":103,"city":127,"state":23,"zip":128,"country":106,"countryCode":107,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Christchurch Hospital, 2 Riccarton Avenue,","Christchurch","8011",{"type":44,"coordinates":130},[131,132],172.63333,-43.53333,{"lat":132,"lon":131},[135],{"name":136,"role":31,"phone":23,"phoneExt":23,"email":23},"Seton Henderson, Dr.",{"facility":138,"status":103,"city":139,"state":23,"zip":140,"country":106,"countryCode":107,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"MRINZ, 7 CSB Building, Wellington Hospital","Wellington","6021",{"type":44,"coordinates":142},[143,144],174.77557,-41.28664,{"lat":144,"lon":143},[147],{"name":148,"role":31,"phone":23,"phoneExt":23,"email":23},"Max Bloomfield, Dr.",{"facility":150,"status":37,"city":151,"state":152,"zip":153,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"University Clinical Centre Nis, Clinic for Infectious Diseases","Niš","Nišava District","18000","Serbia","RS",{"type":44,"coordinates":157},[158,159],21.90333,43.32472,{"lat":159,"lon":158},[162],{"name":163,"role":31,"phone":164,"phoneExt":23,"email":165},"Marina Djordjevic-Spasic, Dr.","+381654100940","marina_djordjevic@yahoo.com",{"facility":167,"status":37,"city":168,"state":169,"zip":170,"country":154,"countryCode":155,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Health Center Uzice, General Hospital Uzice","Užice","Zlatibor District","31000",{"type":44,"coordinates":172},[173,174],19.84878,43.85861,{"lat":174,"lon":173},[177],{"name":178,"role":31,"phone":179,"phoneExt":23,"email":180},"Zorica Radojevic, Dr.","+31599599","drradojevic@gmail.com",{"facility":182,"status":37,"city":183,"state":23,"zip":184,"country":154,"countryCode":155,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"University Clinical Centre of Serbia, Clinic for Infectious Diseases","Belgrade","11000",{"type":44,"coordinates":186},[187,188],20.46513,44.80401,{"lat":188,"lon":187},[191],{"name":192,"role":31,"phone":193,"phoneExt":23,"email":194},"Goran Stevanovic, Prof. Dr.","+3811126883366","goran_drste@yahoo.com",{"type":196,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100643581","phase-2-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-100643581",false,"NCT07633288","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 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","RESPIRE","Inclusion Criteria:\n\n* Written informed consent has been obtained prior to initiating any study-specific procedures\n* 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).\n* 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 %.\n* Duration of disease from first symptom\\\u003C 15 days before enrolment\n* Females of childbearing potential using reliable means of contraception or are post-menopausal or are surgically sterilized\n* Females of childbearing potential with a negative pregnancy test at screening and baseline\n* As the morbidity and mortality of respiratory infections are many fold increased in vulnerable participants, vulnerable participants are not excluded but included as subgroups.\n* 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\n\nExclusion Criteria:\n\n* In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment\n* 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\u002Fvasopressors), or renal failure (Cockcroft-Gault estimated creatinine clearance \\\u003C15 ml\u002Fmin, 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.\n* Participating in other drug clinical trials\n* Any condition that in the view of the screening physician would suggest that the participant is unable to comply with study protocol and procedures\n* 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\u002FCOPD participants are allowed to use their habitual inhalation spray containing adrenocortical hormone.\n* Pregnant women or nursing (breastfeeding) mothers","ALL","18 Years",{"count":208,"type":209},96,"ESTIMATED","INTERVENTIONAL",[212],"PHASE2","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.",[215],"Respiratory Viral Infection",[217,218,219],"Influenza","Respiratory Syncytial virus,","Corona virus","2026-06-08",{"date":222,"type":223},"2026-06-11","ACTUAL",{"date":225,"type":223},"2026-05-01",{"date":227,"type":209},"2027-08-01",{"name":5,"class":6},11]