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    Summary
    EudraCT Number:2020-005104-20
    Sponsor's Protocol Code Number:N-003-CRD008
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-05-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2020-005104-20
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of ambrisentan in patients with severe COVID-19
    Randomizované, dvojito zaslepené, placebom kontrolované klinické skúšanie na vyhodnotenie účinnosti a bezpečnosti ambrisentanu u pacientov s ťažkým COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, double-blind, trial to evaluate efficacy and safety of Ambrisentan in comparison to placebo (inactive drug) in patients with
    severe COVID-19
    Randomizované, dvojito zaslepené klinické skúšanie na vyhodnotenie účinnosti a bezpečnosti ambrisentanu u pacientov s ťažkým COVID-19
    A.4.1Sponsor's protocol code numberN-003-CRD008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNoorik Biopharmaceuticals AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNoorik Biopharmaceuticals AG.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNoorik Biopharmaceuticals AG
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressLange Gasse15
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4052
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41763987007
    B.5.6E-mailinfo@noorik.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameN-003 (Ambrisentan)
    D.3.2Product code N-003
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmbrisentan
    D.3.9.1CAS number 177036-94-1
    D.3.9.4EV Substance CodeSUB25424
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment for respiratory complications of COVID-19 disease
    Liečba respiračných komplikácií ochorenia COVID-19
    E.1.1.1Medical condition in easily understood language
    Treatment for respiratory complications of COVID-19 disease
    Liečba respiračných komplikácií ochorenia COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether N-003 (ambrisentan) can prevent the progression to respiratory failure or death.
    Určiť, či N-003 (ambrisentan) môže zabrániť progresii až do respiračného zlyhania alebo smrti.
    E.2.2Secondary objectives of the trial
    To determine:
    • Whether ambrisentan can delay progression to respiratory failure or death.
    • Whether ambrisentan can reduce dependency on oxygen supplementation and mechanical ventilation.
    • Whether ambrisentan can reduce the duration of hospitalisation.
    • Whether ambrisentan can reduce the need for Intensive Care or High-Dependency Unit.
    • The temporal characteristics of respiratory function in subjects treated with ambrisentan.
    • Whether ambrisentan can improve respiratory function.
    • Whether ambrisentan can reduce the incidence of thrombotic events.
    • Whether ambrisentan can improve the overall clinical status of subjects.
    Určit:
    • Či ambrisentan môže oddialiť progresiu do respiračného zlyhania alebo smrti.
    • Či ambrisentan môže znížiť závislosť na suplementácii kyslíkom a mechanickej ventilácii.
    • Či ambrisentan môže skrátiť dobu hospitalizácie.
    • Či ambrisentan môže znížiť potrebu intenzívnej starostlivosti alebo jednotky vysokej závislosti.
    • Časové charakteristiky respiračnej funkcie u jedincov liečených ambrisentanom.
    • Či ambrisentan môže zlepšiť funkciu dýchania.
    • Či ambrisentan môže znížiť výskyt trombotických príhod.
    • Či ambrisentan môže zlepšiť celkový klinický stav jedincov.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1
    E.3Principal inclusion criteria
    • 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.
    • Účastník (alebo zákonne splnomocnený zástupca) poskytne informovaný súhlas (písomný alebo ústny) pred začatím akýchkoľvek postupov skúšania.
    • Muži alebo netehotné, nekojace ženy. Ženy vo fertilnom veku musia mať v čase skríningu potvrdený negatívny tehotenský test zo séra a musia používať vysoko účinnú metódu antikoncepcie počas celého skúšania (ako sú implantáty, injekčné lieky, hormonálna antikoncepcia a kondóm, dvojitá bariérová antikoncepcia [t. j. kondóm + diafragma/spermicídny gél alebo pena]) a do jedného mesiaca po ukončení liečby skúšaným produktom. V prípade hormonálnej antikoncepcie by ženy mali užívať stabilný režim antikoncepcie minimálne tri mesiace pred zaradením do skúšania. Medzi ženy, ktoré nie sú schopné otehotnieť, patria ženy po menopauze (definované ako ženy, ktoré majú v anamnéze amenoreu po dobu najmenej jedného roka) alebo ženy, ktoré majú zdokumentovaný status chirurgicky sterilné (hysterektómia, bilaterálna ooforektómia, podviazanie vajíčkovodov/salpingektómia).
    Muži musia používať účinnú metódu antikoncepcie (t. j. kondóm + diafragma/spermicidný gél alebo pena alebo vazektómia) a počas skúšania by nemali darovať spermie. Muži sa považujú za plodných od puberty s výnimkou mužov s trvalou sterilitou po bilaterálnej orchiektómii.
    • Vek najmenej 18 rokov a nie viac ako 85 rokov v čase zaradenia do skúšania
    • Potvrdená infekcia SARS-CoV-2 definovaná ako:
    - Pozitívny výsledok testu RT-PCR vo vzorke odobratej počas 10 dní pred randomizáciou, ALEBO
    - Pozitívny výsledok antigénneho testu vo vzorke odobratej v priebehu 10 dní pred randomizáciou.
    • Rádiologické potvrdenie pneumónie.
    • Účastník, ktorý dostáva nízkoprietokovú kyslíkovú suplementáciu s prietokom najmenej 2 l/min a najviac 15 l/min.
    • Účastník (alebo zákonne splnomocnený zástupca) rozumie a súhlasí s dodržiavaním plánovaných postupov skúšania. Účastník (alebo jeho zákonne splnomocnený zástupca) súhlasí s tým, že sa nezúčastní na žiadnom inom klinickom skúšaní vrátane klinických skúšaní na liečbu alebo prevenciu COVID-19 alebo SARS-CoV-2 do 30. dňa.
    E.4Principal exclusion criteria
    • 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.
    • Účastník s vysokým rizikom úmrtia, a to podľa názoru skúšajúceho,
    do 3 mesiacov po zaradení do skúšania z iných príčin ako kvôli syndrómu akútnej respiračnej tiesne (napr. závažné neurologické poškodenie alebo pacienti s rakovinou v terminálnom štádiu ochorenia).
    • Účastník, ktorý je v súčasnosti liečený antagonistom endotelínových receptorov.
    • Účastník, ktorý je v súčasnosti liečený iným pľúcnym vazodilatanciom.
    • Predpokladaná potreba suplementácie kyslíkom s vysokým prietokom, neinvazívnej mechanickej ventilácie, endotracheálnej intubácie alebo tracheostómie v čase skríningu.
    • Účastník s anamnézou mechanickej ventilácie (invazívnej alebo neinvazívnej) za posledných 7 dní.
    • Účastník so zdokumentovanou anamnézou konečného štádia ochorenia pečene, cirhózy alebo idiopatickej pľúcnej fibrózy (IPF) s pľúcnou arteriálnou hypertenziou alebo bez nej.
    • Účastník s AST alebo ALT > 3-násobok hornej hranice normy (ULN).
    • Účastník s predpokladaným prepustením z nemocnice alebo preložením do inej nemocnice, ktorá nie je pracoviskom klinického skúšania, do 96 hodín.
    • Účastník, ktorý sa zúčastňuje na inom intervenčnom klinickom skúšaní počas 15 dní pred zaradením do skúšania.
    • Známa precitlivenosť na ambrisentan alebo propylénglykol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is
    • Proportion of subjects alive and not having developed respiratory failure from randomisation to Day 30
    Primárnym koncovým ukazovateľom účinnosti je
    • Podiel účastníkov nažive a bez rozvinutia respiračného zlyhania od randomizácie do 30. dňa
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression to respiratory failure, and the proportion of patients not developing respiratory failure in a 30-day observation period
    Progresia do respiračného zlyhania a podiel pacientov, u ktorých sa počas 30-dňového obdobia pozorovania nevyvinie respiračné zlyhanie
    E.5.2Secondary end point(s)
    The secondary endpoints evaluated in this study will consist of:
    • Proportion of subjects alive and free of respiratory failure at Day 14 and Day 30.
    • Proportion of subjects alive and not requiring oxygen supplementation or higher respiratory support at Day 14 and Day 30.
    • Time to hospital discharge (up to Day 30).
    • Proportion of subjects admitted to the Intensive Care Unit or High-Dependency Unit (up to Day 30).
    • Time until weaning from oxygen therapy (up to Day 30).
    • Time until weaning from respiratory support other than low-flow oxygen supplementation for subjects having developed respiratory failure (up to Day 30).
    • Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 3.
    • Change in SpO2/FiO2 from baseline to the time-weighted average obtained on Day 1 and Day 2.
    • Proportion of subjects experiencing at least one event of venous thrombosis (specifically deep venous thrombosis or pulmonary embolism) (up to Day 30).
    • Proportion of subjects by clinical status reported on a 11-point ordinal scale at Day 14 and Day 30.
    • Time to death due to any cause (up to Day 30).
    • All-cause mortality at Day 30.
    Sekundárne koncové ukazovatele hodnotené v tomto klinickom skúšaní budú pozostávať z:
    • Podiel jedincov žijúcich a bez respiračného zlyhania v deň 14 a deň 30.
    • Podiel jedincov nažive a nevyžadujúcich suplementáciu kyslíkom alebo vyššiu podporu dýchania na 14. a 30. deň.
    • Čas do prepustenia z nemocnice (do 30. dňa).
    • Podiel subjektov prijatých na jednotku intenzívnej starostlivosti alebo jednotku vysokozávislej starostlivosti (do 30. dňa).
    • Čas do odvykania od oxygenoterapie (do 30. dňa).
    • Čas do odvykania od podpory dýchania inej ako suplementácia kyslíkom s nízkym prietokom u jedincov, u ktorých sa rozvinulo respiračné zlyhanie (do 30. dňa).
    • Zmena SpO2/FiO2 z východiskovej hodnoty na časovo vážený priemer získaný v deň 3.
    • Zmena SpO2/FiO2 z východiskovej hodnoty na časovo vážený priemer získaný v 1. a 2. deň.
    • Podiel jedincov, u ktorých sa vyskytla aspoň jedna príhoda venóznej trombózy (konkrétne hlboká venózna trombóza alebo pľúcna embólia) (do 30. dňa).
    • Podiel subjektov podľa klinického stavu hlásený na 11-bodovej ordinálnej stupnici na 14. a 30. deň.
    • Čas smrti z akejkoľvek príčiny (do 30. dňa).
    • Úmrtnosť zo všetkých príčin na 30. deň.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for each secondary endpoint are indicated in secondary endpoint section E.5.2
    Časové body pre každý sekundárny ukazovateĺ sú uvedené v sekcii E.5.2 sekundárneho parametra
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Romania
    Spain
    Czechia
    Croatia
    Georgia
    Slovakia
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit
    Posledná návšteva posledného pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If patient is unable to sign informed consent the consent may be signed by patient's legal representative
    Ak pacient nemôže podpísať informovaný súhlas, súhlas môže podpísať zákonný zástupca pacienta
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 194
    F.4.2.2In the whole clinical trial 232
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Žiadny
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-02-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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