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    Summary
    EudraCT Number:2020-002677-95
    Sponsor's Protocol Code Number:ABC-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002677-95
    A.3Full title of the trial
    Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: a Randomized, Double-blind, Placebo-Controlled Phase 2/3 Study, in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia
    Opaganib, un inibitore della sfingosina chinasi-2 (SK2) nella polmonite da COVID-19: studio di fase 2/3 randomizzato, in doppio cieco, controllato con placebo in soggetti adulti ricoverati con polmonite positiva al SARS-CoV-2 grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial using opaganib in adult patients hospitalised with severe pneumonia due to COVID-19
    Uno studio clinico con opaganib su pazienti adulti ricoverati in ospedale con polmonite grave a causa di COVID-19
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberABC-201
    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 SponsorRedHill Biopharma Limited
    B.1.3.4CountryIsrael
    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 supportRedHill Biopharma Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRedHill Biopharma Ltd.
    B.5.2Functional name of contact pointABC-201 Study Information
    B.5.3 Address:
    B.5.3.1Street Address21 Ha’arba’a St.
    B.5.3.2Town/ cityTel-Aviv
    B.5.3.3Post code6473921
    B.5.3.4CountryIsrael
    B.5.6E-mailinfo@redhillbio.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 nameOpaganib
    D.3.2Product code [ABC294640]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOpaganib
    D.3.9.2Current sponsor codeABC294640
    D.3.9.4EV Substance CodeSUB189969
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule, hard
    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
    Severe SARS-CoV-2 Positive Pneumonia
    Polmonite positiva al SARS-CoV-2 grave
    E.1.1.1Medical condition in easily understood language
    Severe pneumonia due to COVID-19
    Polmonite grave causata da SARS-CoV-2
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14
    Valutare la proporzione di pazienti richiedenti intubazione e ventilazione meccanica entro il Giorno 14
    E.2.2Secondary objectives of the trial
    To evaluate:
    1) change on the WHO Ordinal Scale for Clinical Improvement
    2) the time to intubation and mechanical ventilation
    3) the time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option
    4) the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14
    5) the total oxygen requirement (area under the curve) using daily supplemental oxygen flow (L/min) over 14 days (Day 1 to Day 14)
    6) the time to two consecutive negative swabs for SARS-CoV-2 by PCR
    7) the proportion of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14
    8) the proportion of patients, with at least one measurement of fever at baseline (defined as temperature >38.0°C [100.4°F]), who are afebrile (defined as temperature <37.2°C [99°F]) at Day 14
    9) mortality 30 days post-baseline
    Valutare:
    1) variazione sulla scala ordinale di miglioramento clinico dell’OMS
    2) tempo all’intubazione e alla ventilazione meccanica
    3) tempo a ossigeno a bassi flussi attraverso cannula nasale, p.es. da ossigeno ad alti flussi attraverso cannula nasale, o CPAP, se l’ossigeno ad alti flussi non è un’opzione disponibile
    4) proporzione di pazienti che non richiedono più supporto di ossigeno per almeno 24 ore entro il Giorno 14
    5) fabbisogno totale di ossigeno (area sotto la curva) usando il flusso di supporto di ossigeno giornaliero (L/min) per 14 giorni (dal Giorno 1 al Giorno 14)
    6) tempo a due tamponi negativi consecutivi per SARS-CoV-2 mediante PCR
    7) proporzione di pazienti con due tamponi negativi consecutivi per SARS-CoV-2 mediante PCR al Giorno 14
    8) proporzione di pazienti, con almeno una misurazione di febbre al basale (definita come temperatura >38,0 C [100,4 F]), afebbrili (ossia con temperatura <37,2 C [99 F]) al Giorno 14
    9) mortalità a 30 giorni dal basale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Adult male or female =18 to =80 years of age
    2) Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray or CT scan
    3) The patient requires, at baseline, high flow supplemental oxygen or CPAP, if high oxygen flow is not an available option
    4) Patient agrees to use appropriate methods of contraception during the study and 3 months after the last dose of study drug
    5) The patient or legal representative has signed a written informed consent approved by the IRB/Ethics Committee
    1. Soggetti adulti di sesso maschile o femminile di età =18 e =80 anni
    2. Infezione COVID-19 accertata mediante analisi RT-PCR di un campione faringeo (nasofaringeo od orofaringeo) E polmonite definita come opacità radiografiche all’esame radiografico standard o TAC
    3. Al basale, il paziente richiede supporto di ossigeno ad alti flussi, o CPAP, se l’ossigeno ad alto flusso non è un’opzione disponibile
    4. Il paziente utilizza opportuni metodi contraccettivi durante lo studio e 3 mesi dopo l’ultima dose di farmaco in studio
    5. Il paziente o rappresentante legale, ha firmato un consenso informato scritto approvato dal Comitato Etico
    E.4Principal exclusion criteria
    1) Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
    2) Requiring intubation and mechanical ventilation
    3) Oxygen saturation >95% on room air
    4) Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
    5) Patient is, in the investigator’s clinical judgement, unlikely to survive >72 hours
    6) Pregnant (positive serum or urine test within 3 days prior to randomization) or nursing women
    7) Unwillingness or inability to comply with procedures required in this protocol.
    8) Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms for males, calculated using Friedericia’s formula (QTcF)
    9) AST (SGOT) or ALT (SGPT) > 2.5 x upper limit of normal (ULN)
    10) Total bilirubin >1.5x ULN (except where bilirubin increase is due to Gilbert’s Syndrome)
    11) Serum creatinine >2.0 X ULN
    12) Absolute neutrophil count <1000 cells/mm3
    13) Platelet count <75,000/mm3
    14) Hemoglobin <8.0 g/dL
    15) Currently taking medications that are sensitive CYP3A4, CYP2C9 or CYP2C19 substrates and have a narrow therapeutic index
    16) Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4
    17) Currently taking warfarin, apixaban, argatroban or rivaroxaban due to drug-drug interaction based on CYP450 metabolism
    18) Current drug or alcohol abuse
    19) Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies
    1. Qualsiasi comorbilità che, a giudizio dello sperimentatore, possa incrementare il rischio del trattamento.
    2. Necessità di intubazione e ventilazione meccanica
    3. Saturazione di ossigeno >95% in aria ambiente
    4. Qualsiasi condizione respiratoria preesistente richiedente ossigenoterapia domiciliare intermittente o continua prima dell’ospedalizzazione
    5. Improbabilità che il paziente, secondo il giudizio clinico dello sperimentatore, sopravviva >72 ore
    6. Donne in gravidanza (test su siero o urina positivo nei 3 giorni precedenti la randomizzazione) o che allattano
    7. Indisponibilità o incapacità di rispettare le procedure richieste dal presente protocollo.
    8. Intervallo QT corretto (QTc) all’elettrocardiogramma (ECG) >470 ms per soggetti di sesso femminile o >450 ms per soggetti di sesso maschile, calcolato usando la formula di Fridericia (QTcF)
    9. AST (SGOT) o ALT (SGPT) > 2,5x il limite superiore della norma (ULN)
    10. Bilirubina totale >1,5x ULN (salvo nel caso in cui l’aumento della bilirubina sia dovuto alla sindrome di Gilbert)
    11. Creatinina sierica >2,0 X ULN
    12. Conta assoluta dei neutrofili <1000 cellule/mm3
    13. Conta piastrinica <75.000/mm3
    14. Emoglobina <8,0 g/dL
    15. Assunzione in corso di farmaci substrati sensibili di CYP3A4, CYP2C9 o CYP2C19 e che presentano un indice terapeutico ristretto
    16. Assunzione in corso di farmaci che sono forti induttori o inibitori di CYP2D6 e CYP3A4
    17. Assunzione in corso di warfarin, apixaban, argatroban o rivaroxaban a causa di interazione farmacologica basata sul metabolismo CYP450
    18. Abuso corrente di sostanze o alcol
    19. Partecipazione in corso a uno studio clinico di valutazione di trattamenti farmacologici, inclusi studi di antivirali
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients requiring intubation and mechanical ventilation by Day 14
    Percentuale di pazienti richiedenti intubazione e ventilazione meccanica entro il Giorno 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    Giorno 14
    E.5.2Secondary end point(s)
    1) The percentage of patients with =2 category improvement on the WHO Ordinal Scale for Clinical Improvement
    2) The time to intubation and mechanical ventilation
    3) The time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option
    4) The percentage of patients no longer receiving supplemental oxygen for at least 24 hours by Day 14
    5) The total oxygen requirement (area under the curve) using the daily supplemental oxygen flow (L/min) over 14 days (Day 1 to Day 14)
    6) The time to two consecutive negative swabs for SARS-CoV-2 by PCR, at least 24 hours apart
    7) The percentage of patients with at least two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14
    8) The percentage of patients with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14
    9) Mortality due to any cause at Day 30 after baseline
    1) Percentuale di pazienti con un miglioramento di =2 categorie in base alla scala ordinale di miglioramento clinico dell’OMS
    2) Tempo all’intubazione e alla ventilazione meccanica
    3) Tempo a ossigeno a bassi flussi attraverso cannula nasale, p.es. da ossigeno ad alti flussi attraverso cannula nasale, o CPAP, se l’ossigeno ad alti flussi non è un’opzione disponibile
    4) Percentuale di pazienti che non ricevono più supporto di ossigeno per almeno 24 ore entro il Giorno 14
    5) Fabbisogno totale di ossigeno (area sotto la curva) usando il flusso di supporto di ossigeno giornaliero (L/min) per 14 giorni (dal Giorno 1 al Giorno 14)
    6) Tempo a due tamponi negativi consecutivi per SARS-CoV-2 mediante PCR, a distanza di almeno 24 ore
    7) Percentuale di pazienti con almeno due tamponi negativi consecutivi per SARS-CoV-2 mediante PCR al Giorno 14
    8) Percentuale di pazienti, con almeno una misurazione di febbre al basale (definita come temperatura >38,0 C [100,4 F]), afebbrili (ossia con temperatura <37,2 C [99 F]) al Giorno 14
    9) Mortalità per qualsiasi causa al Giorno 30 dopo il basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    The following reflects the timepoints for the secondary endpoints listed above:
    1) Day 1, 7 and 14
    2) Day 1 to Day 14
    3) Day 1 to Day 14
    4) Day 14
    5) Day 1 to Day 14
    6) Day 1 to Day 14
    7) Day 14
    8) Day 14
    9) Day 30
    Quanto segue riflette i punti temporali per gli endpoint secondari sopra elencati:
    1) Giorno 1, 7 e 14
    2) Giorno 1 al Giorno 14
    3) Giorno 1 al Giorno 14
    4) Giorno 14
    5) Giorno 1 al Giorno 14
    6) Giorno 1 al Giorno 14
    7) Giorno 14
    8) Giorno 14
    9) Giorno 30
    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 No
    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) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Italy
    Mexico
    Russian Federation
    United Kingdom
    United States
    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
    LVLS
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 162
    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
    Depending on the severity of infection some hospitalized patients may be unable to give consent personally. In this instance signed written informed consent must be obtained from the patient's legal representative prior to study entry.
    A seconda della gravità dell'infezione, alcuni pazienti ospedalizzati possono non essere in grado di dare il consenso personalmente. In questo caso il consenso informato firmato scritto deve essere ottenuto dal legale rappresentante del paziente prim
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 270
    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
    Nessuno
    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 Decision2020-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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