COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005104-20/HR

Noorik Biopharmaceuticals AG - CEO

iker.navarro@noorik.com

2022-12-06

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Subject (or legally authorized representative) provides informed consent (written or oral) prior to initiation of any study procedures. Male or non-pregnant, non-lactating female. Women of child-bearing potential must have a confirmed negative serum pregnancy test at the time of screening and must use a highly effective contraceptive method throughout the study (such as implants, injectables, hormonal contraceptives and condom, double barrier contraception [i.e., condom + diaphragm/spermicidal gel or foam]) and until one month after completing treatment with the study medication. In the case of hormonal contraception, women should have been on a stable regimen for a minimum of three months before study enrolment. Women not of child-bearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy). Men must use an effective contraception method (i.e., condom + diaphragm/spermicidal gel or foam, or vasectomy), and should not donate semen during the study. Men are considered to be fertile from the time of puberty, except for those men with permanent sterility secondary to bilateral orchiectomy. At least 18 years of age and not older than 85 years of age at time of enrolment Confirmed SARS-CoV-2 infection defined as: - Positive RT-PCR result in sample collected in the 10 days prior to randomisation, OR - Positive antigenic test result in sample collected in 10 days prior to randomisation. Radiological confirmation of pneumonia. Subject receiving low-flow oxygen supplementation of at least 3 L/min and not more than 15 L/min. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. Subject (or legally authorized representative) agrees to not participate in any other clinical trial, including clinical trials for the treatment or prevention of COVID-19 or SARS-CoV-2 through Day 30. Bolesnik (ili zakonski zastupnik) koji je dao informirani pristanak (pismeni ili usmeni) prije pokretanja bilo kakvog postupka u ispitivanju. Muškarac ili žena koja nije trudna, niti ne doji. Žene reproduktivne dobi moraju imati potvrđen negativan serumski test na trudnoću u vrijeme probira i moraju koristiti visoko učinkovitu metodu kontracepcije tijekom cijelog ispitivanja (kao što su implantati, injekcije, hormonski kontra-ceptivi i kondomi, kontracepcija s dvostrukom barijerom [tj. kondom + dijafragma/spermicidni gel ili pjena]) i do mjesec dana nakon završetka liječenja ispitivanim lijekom. U slučaju hormonske kontracepcije, žene trebaju biti na stabilnom režimu najmanje tri mjeseca prije uključivanja u ispitivanje. Žene u postmenopauzi (definirano kao da imaju amenoreju u anamnezi najmanje godinu dana) ili uz dokumentirani status kirurške sterilizacije (histerektomija, bilateralna ooforektomija, podvezani jajovodi/salpingektomija). Muškarci moraju koristiti učinkovitu metodu kontracepcije (tj. kondom + dijafragma/sper-micidni gel ili pjena, ili vazektomija) i ne bi trebali donirati spermu tijekom ispitivanja. Smatra se da su muškarci plodni od puberteta, osim onih muškaraca s trajnim sterilitetom koji je posljedica bilateralne orhidektomije. Najmanje navršenih 18 godina i ne stariji od 85 godina u trenutku uključivanja Potvrđena SARS-CoV2 infekcija definirana kao: - Pozitivan RT-PCR test na uzorku prikupljenom unutar 10 dana prije randomizacije, ILI - Pozitivan antigenski test na uzorku prikupljenom unutar 10 dana prije randomizacije. Radiološka potvrda upale pluća. Bolesnik koji prima nadomjesnu terapiju kisikom niskog protoka od najmanje 2 l/min i ne više od 15 l/min. Bolesnik (ili zakonski zastupnik) razumije i pristaje poštivati planirane postupke u ispitivanju. Bolesnik (ili zakonski zastupnik) pristaje ne sudjelovati u bilo kojem drugom kliničkom ispitivanju, uključujući klinička ispitivanja za liječenje ili prevenciju bolesti COVID-19 ili SARS-CoV-2 infekcije do 30. dana ispitivanja.

Subject at a high risk of death, according to investigator’s opinion, in the 3 months following enrolment from other causes than Acute Respiratory Distress Syndrome (e.g., severe neurological damage or cancer patients in terminal stages of the disease). Subject currently being treated with an endothelin receptor antagonist. Subject currently being treated with another pulmonary vasodilator. Anticipated need for high-flow oxygen supplementation, non-invasive mechanical ventilation, endotracheal intubation or tracheostomy at the time of screening.. History of mechanical ventilation (invasive or non-invasive) in the last 7 days. Documented history of end-stage liver disease, cirrhosis or idiopathic pulmonary fibrosis (IPF) with or without pulmonary arterial hypertension. AST o ALT > 3-times the upper limit of normal (ULN) Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 96 hours. Participation in another interventional clinical trial in the 15 days prior to enrolment. Known hypersensitivity to ambrisentan or propylene glycol. Prema mišljenju ispitivača, kod bolesnika postoji visoki rizik od smrti, unutar 3 mjeseca nakon uključivanja, iz drugih uzroka osim akutnog respiratornog distres sindroma (npr. teška neurološka oštećenja ili pacijenti s rakom u terminalnoj fazi bolesti). Bolesnik koji se trenutno liječi antagonistom endotelinskog receptora. Bolesnik se trenutno liječi drugim plućnim vazodilatatorom. neinvazivnom mehaničkom ventilacijom, endotrahealnom intubacijom ili traheostomijom u vrijeme probira. Povijest mehaničke ventilacije (invazivne ili neinvazivne) u zad-njih 7 dana. Dokumentirana povijest bolesti jetre u završnoj fazi, ciroze ili idiopatske plućne fibroze (IPF) sa ili bez plućne arterijske hipertenzije. AST ili ALT > 3-puta iznad gornje granice normalne vrijednosti (ULN) Očekivani otpust iz bolnice ili premještaj u drugu bolnicu izvan mjesta ispitivanja unutar 96 sati. Sudjelovanje u drugom intervencijskom kliničkom ispitivanju 15 dana prije uključivanja Poznata preosjetljivost na ambrisentan ili propilen glikol. potreba za nadomjesnu terapiju kisikom visokog protoka

2

Noorik Biopharmaceuticals AG

18

85

Croatia;Czech Republic;Georgia;Romania;Slovakia;Spain;Switzerland

Severe disease at enrollment

6: Severe disease at enrollment

50

The primary efficacy endpoint is • Proportion of subjects alive and not having developed respiratory failure from randomisation to Day 30 Primarna krajnja točka učinkovitosti je: Udio ispitanika koji su ostali živi i kod kojih nije došlo do respiratornog zatajenja, od randomizacije do 30. dana.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 75, "treatment_name": "Ambrisentan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]