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    Summary
    EudraCT Number:2020-001367-88
    Sponsor's Protocol Code Number:25032020
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-01
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-001367-88
    A.3Full title of the trial
    Efficacy and safety of novel treatment options for adults with COVID-19 pneumonia. A double-blinded, randomized, multi-stage, 6-armed placebo-controlled trial in the framework of an adaptive trial platform
    Effekt og sikkerhed af nye behandlingsmuligheder af voksne med COVID-19 lungebetændelse. Et dobbeltblindet, randomiseret, multi-stadie, 6-armet placebo-kontrolleret forsøg.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of novel treatment options for adults with COVID-19 pneumonia
    Effekt og sikkerhed af nye behandlingsmuligheder af voksne med COVID-19 lungebetændelse.
    A.3.2Name or abbreviated title of the trial where available
    CCAP-RCT
    A.4.1Sponsor's protocol code number25032020
    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 SponsorDepartment of Infectious diseases
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDepartment of Infectious Diseases, Hvidovre Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportLundbeck fonden
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of infectious diseases
    B.5.2Functional name of contact pointCharlotte Kastberg Levin
    B.5.3 Address:
    B.5.3.1Street AddressKettegaard Allé 30
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538622941
    B.5.6E-mailcharlotte.kastberg.levin.01@regionh.dk
    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 Yes
    D.2.1.1.1Trade name Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namePlaquenil
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 747-36-4
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameOlumiant
    D.3.4Pharmaceutical form Tablet
    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 INNBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Kevzara
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameKevzara
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARILUMAB
    D.3.9.4EV Substance CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameOlumiant
    D.3.4Pharmaceutical form Tablet
    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 INNBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 after infection with SARS-CoV-2
    COVID-19 efter infektion med Ny Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    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
    The aim of this study is to evaluate the efficacy and safety of convalescent anti-SARS-CoV-2 plasma, hydroxychloroquine, sarilumab and baricitinib compared with placebo in combination with standard of care (SOC) for the treatment of moderate-to-severe COVID-19 pneumonia on the basis of the composite endpoint: All-cause mortality or need of invasive mechanical ventilation up to 28 days.
    Formålet med forsøget er at undersøge, om én eller flere af i alt 4 typer af behandling til patienter indlagt med moderat-svær lungebetændelse forårsaget af den nye coronavirus SARS-CoV-2 er mere effektivt til at mildne sygdomsforløbet og forhindre alvorlig sygdom end understøttende behandling alene.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ● ≥18 years of age
    ● Confirmed COVID-19 infection per WHO criteria / presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR)
    ● Evidence of pneumonia given by at least one of the following:
    ○ SpO2 ≤93% on ambient air or PaO2/FiO2 <300 mmHg/40 kPa
    ○ Radiographic findings compatible with COVID-19 pneumonia
    ● Onset of first experienced symptom, defined as one respiratory symptom or fever, no more than 10 days before admission
    ● For women of childbearing potential: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period
    ● Signed Informed Consent Form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
    ● Alder ≥18 år
    ● Bekræftet COVID-19 infektion
    ● Mindst én af følgende tegn på lungebetændelse:
    ○ Iltmætning under 94%
    ○ Fund på røntgen af brystkassen forenelig med COVID-19 infektion i lungerne
    ● Symptomdebut max 10 dage før indlæggelse
    ● For kvinder i den fertile alder skal der foreligge en negativ graviditetstest, og der skal anvendes prævention gennem hele studieperioden
    ● Signeret informeret samtykkeerklæring af patienten selv eller af en legal repræsentant for patienten i tilfælde af inhabil patient
    E.4Principal exclusion criteria
    ● In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
    ● History of allergic reaction to study drug (as judged by the site investigator)
    ● Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by sponsor)
    ● Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination or patients family planning within three months after receiving study agent
    ● Estimated glomerular filtration (eGFR) <30 ml/min
    ● Severe liver dysfunction (Child Pugh score C)
    ● Known history of the following medical conditions:
    ○ Active or latent tuberculosis (TB) or history of incompletely treated TB
    ○ Chronic hepatitis B or C infection
    ○ Retinopathy or maculopathy
    ○ Neurogenic hearing impairment
    ● Presence of any of the following abnormal laboratory values at screening:
    ○ Absolute neutrophil count (ANC) less than 1000 mm3 (= 1,0 x 10⁹ /L)
    ○ Alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN)
    ○ Platelet count <50,000 per mm3 (= 50 x 10⁹ /L)
    ● Immunosuppression, defined as following:
    ○ Treatment with immunosuppressive agents, chemotherapy or immunomodulatory drugs within 30 days prior to inclusion
    ○ Use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisolone 20 mg or equivalent per day for 4 weeks
    ○ Ongoing chemotherapy
    ● Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
    ● Nært forestående død (inden for de følgende 24 timer) uafhængigt af behandlingstiltag, efter investigators vurdering
    ● Kendt allergi over for én eller flere af forsøgsbehandlingerne
    ● Deltagelse i et andet behandlingsforsøg (dog vil deltagelse i andre COVID-19 antivirale forsøg evt. tillades, hvis sponsor godkender dette)
    ● Graviditet eller amning
    ● Nedsat nyrefunktion (svarende til estimeret glomerulær filtrationsrate <30 ml/min)
    ● Svær leverdysfunktion (svarende til Child Pugh score C)
    ● Kendt med følgende sygdomme:
    ○ Aktivt eller latent tuberkulose
    ○ Kronisk infektion med hepatitis B eller C
    ○ Øjensygdom (i form af retinopati eller makulopati)
    ○ Neurogen hørenedsættelse
    ● Tilstedeværelse af én eller flere af de følgende abnorme laboratorieværdier:
    ○ Neutrofile leukocytter < 1,0 x 10⁹ /L
    ○ Alanin-aminotransferase > 5 x øvre normalgrænse
    ○ Blodplader < 50 x 10⁹ /L
    ● Immunsuppression, defineret som:
    ○ Behandling med immunosuppressive midler, kemoterapi eller immunmodulerende midler inden for 30 dage forud for inklusion
    ○ Langvarig behandling med binyrebarkhormon (svarende til >20 mg prednisolon per dag i >4 uger)
    ● Enhver alvorlig medicinsk tilstand eller abnorm laboratorietest, som efter investigators vurdering er uforenelig med opretholdelse af patients sikkerhed ved deltagelse i studiet
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is a composite endpoint: All-cause mortality or need of invasive mechanical ventilation up to 28 days.
    Det primære endepunkt er et sammensat endepunkt bestående af 1) mortalitet eller 2) behov for mekanisk ventilation frem til dag 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Dag
    E.5.2Secondary end point(s)
    ● Frequency of adverse events
    ● Frequency of severe adverse events
    ● Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status
    ● Ventilator-free days to day 28
    ● Organ failure-free days to day 28
    ● Duration of ICU stay
    ● Mortality rate at days 7, 14, 21, 28, and 90
    ● Length of hospital stay
    ● Duration of supplemental oxygen
    De sekundære endepunkter er: Frekvens af bivirkninger og alvorlige bivirkninger, bedring i funktionsniveau, antal dage uden respirator til dag 28, antal dage uden organsvigt til dag 28, antal dage på intensiv afsnit, antal dage med ilttilskud, længden af hospitalsindlæggelse samt mortalitetsraten på dag 7, 14, 21, 28 og 90.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See individual timepoints E.5.2.
    Se individuelle tidspunkter E.5.2.
    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) No
    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 Yes
    E.8.1.7.1Other trial design description
    Multi-stage, adaptive
    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 trial6
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    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: 750
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 750
    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 No
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Unconscious patients e.g. patients in intensive care and mechanical ventilation incapable of giving consent, can be included in the study if consent is given by a legal/authorized representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1500
    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
    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 Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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