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    Summary
    EudraCT Number:2020-001500-41
    Sponsor's Protocol Code Number:COV-AID
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-001500-41
    A.3Full title of the trial
    A prospective, randomized, factorial design, interventional study to compare the safety and efficacy of combinations of blockade of interleukin-6 pathway and interleukin-1 pathway to best standard of care in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure and systemic cytokine release syndrome.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of COVID-19 patients with anti-interleukin drugs
    A.3.2Name or abbreviated title of the trial where available
    COV-AID
    A.4.1Sponsor's protocol code numberCOV-AID
    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 SponsorUniversity Hospital Ghent
    B.1.3.4CountryBelgium
    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 supportUniversity Hospital Ghent
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportKCE Belgian Health Care Knowledge Centre
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Ghent
    B.5.2Functional name of contact pointHIRUZ CTU
    B.5.3 Address:
    B.5.3.1Street AddressC. Heymanslaan 10
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3293320500
    B.5.5Fax number+3293320520
    B.5.6E-mailhiruz.ctu@uzgent.be
    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 Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameKineret
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRoActemra
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRoActemra
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number162
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 SYLVANT
    D.2.1.1.2Name of the Marketing Authorisation holderEUSA Pharma
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameSYLVANT
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSiltuximab
    D.3.9.1CAS number 541502-14-1
    D.3.9.4EV Substance CodeSUB32552
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 patients with acute hypoxic respiratory failure and systemic cytokine release syndrome.
    E.1.1.1Medical condition in easily understood language
    COVID-19 patients with acute hypoxic respiratory failure and systemic cytokine release syndrome.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study if blockade of IL-6 +/- IL-1 to block the cytokine storm and acute lung injury in comparison with usual care reduces time to clinical improvement as defined by an increase of more than 2 on the 6 point ordinal scale or discharge from the hospital
    E.2.2Secondary objectives of the trial
    -to investigate whether treatment with either tocilizumab, siltuximab, anakinra or combinations thereof
    -improves oxygenation
    -causes defervescence, measured as time to first fever-free 48h period
    -improves features of secondary haemophagocytic lymphohistiocytosis
    -improves features of secondary haemophagocytic lymphohistiocytosis in relation to serum IL-6 and IL-1
    -affects clinical outcome in relation to IL-6 and IL-1 levels
    -affects the rate of nosocomial infection
    -affects progression to mechanical ventilation, high oxygen delivery device, and/or ARDS in non-ventilated patients
    -affects length of dependency of ventilation in ventilated patients
    -affects all-cause mortality rate at 4 and 20 weeks post inclusion
    -affects long term 10-20 week follow up clinical status and lung function
    -is safe (number of AEs/SAEs)
    -When there is a significant association between IL-6 blockade and time to clinical improvement, tocilizumab and siltuximab will be compared versus usual care
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Recent (≥6 days of flu-like symptoms or malaise yet ≤16 days of flu-like symptoms or malaise prior to
    randomization) infection with COVID-19.Confident COVID-19 diagnosis confirmed by antigen detection
    test and/or PCR and/or positive serology, or any emerging and validated diagnostic laboratory test for
    COVID-19 within this period.
    -In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19
    diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic
    sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral
    ground glass opacities on recent (<24h) chest-CT scan (confirmed by a radiologist and pulmonary
    physician as probable COVID-19), and a typical clinical and chemical diagnosis with signs of cytokine
    release syndrome, a patient can be enrolled as probable COVID-19 infected. In all cases, this needs
    confirmation by later seroconversion.
    -Presence of hypoxia defined as
    PaO2/FiO2 below 350 while breathing room air in upright position or PaO2/FiO2 below 280 on
    supplemental oxygen and immediately requiring high flow oxygen device or mechanical
    ventilation.
    -signs of cytokine release syndrome defined as
    ANY of the following
    -serum ferritin concentration >1000 mcg/L and rising since last 24h
    -single ferritin above 2000 mcg/L in patients requiring immediate high flow oxygen device or
    mechanical ventilation
    -lymphopenia defined as <800 lymphocytes/microliter and two of the following extra criteria
    Ferritin > 700 mcg/L and rising since last 24h
    -increased LDH (above 300 IU/L) and rising since last 24h
    -D-Dimers > 1000 ng/mL and rising since last 24h
    -CRP above 70 mg/L and rising since last 24h and absence of bacterial infection
    -if three of the above are present at admission, no need to document 24h rise
    -Chest X-ray and/or CT scan showing bilateral infiltrates within last 2 days
    -Admitted to specialized COVID-19 ward or an ICU ward taking care of COVID-19 patients
    -Age ≥ 18 years
    -Male or Female
    - Women of childbearing potential must have a negative serum pregnancy test pre-dose on day 1.
    Women of childbearing potential must consistently and correctly use (during the entire treatment
    period and 3 months after last reatment) 1 highly effective method for contraception.
    -Willing and able to provide informed consent or legal representative willing to provide informed
    consent
    E.4Principal exclusion criteria
    -Patients with known history of serious allergic reactions, including anaphylaxis, to any of the study medications, or any component of the product.
    -mechanical ventilation > 24 h at randomization
    -clinical frailty scale above 3
    -active bacterial or fungal infection
    -unlikely to survive beyond 48h
    -neutrophil count below 1500 cells/microliter
    -platelets below 50.000/microliter
    -Patients enrolled in another investigational drug study
    -patients on high dose systemic steroids (> 8 mg methylprednisolone or equivalent for more than 1 month) for COVID-19 unrelated disorder
    -patients on immunosuppressant or immunomodulatory drugs
    -patients on current anti-IL1 or anti-IL6 treatment
    -signs of active tuberculosis
    -serum transaminase levels >5 times upper limit of normal, unless there are clear signs of cytokine release syndrome defined by LDH >300 IU/L and ferritin >700 ng/ml
    -history of (non-iatrogenic) bowel perforation or diverticulitis
    - Pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening)
    E.5 End points
    E.5.1Primary end point(s)
    Time to clinical improvement (defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death)
    1. Death
    2. Hospitalized, on invasive mechanical ventilation or ECMO;
    3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen
    5. Hospitalized, not requiring supplemental oxygen
    6. Not hospitalized
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    -Time since randomization until improvement in oxygenation, defined as independence from supplemental oxygen
    -Mean change in oxygenation defined by Pa02/FiO2 while breathing room air between day 1 and day 15 (or hospital discharge, whichever is first)
    -Number of days with hypoxia
    -Number of days of supplemental oxygen use
    -Time since randomization until absence of fever for more than 48h without antipyretics
    -Number of days with fever
    -Time since randomization until halving of CRP levels compared to peak value during trial
    -Time since randomization until halving of ferritin levels compared to peak value during trial
    -Incidence of AEs/SAEs during 28 days
    -Duration of hospital stay
    -Duration of hospital stay in survivors
    -Mean change in clinical sign score between day 1 and day 7 and between day 1 and day 15 (or on discharge, whichever is first)
    -Time since randomization until clinical sign score <6 maintained for 24h
    -Mean change of SOFA score between day 1 and day 7 or between day 1 and day 15 (or on discharge, whichever is first)
    -Mean change NEWS2 score between day 1 and day 7 or between day 1 and day 15 (or on discharge, whichever is first)
    -Time since randomization until NEWS2 score less than 2 for at least 24h
    - Percentage of patients reporting each severity rating on a 6-point ordinal scale
    6-point Ordinal Scale at 15 days, in relation to serum IL-1 and IL-6
    - Incidence of nosocomial bacterial or invasive fungal infection for 28 days after enrolment in trial
    - incidence of secondary haemophagocytic lymphohistiocytosis defined by Hs score
    Cardinal features of sHLH include unremitting fever, cytopenias, hyperferritinaemia, hypertriglyceridemia, pulmonary involvement can present as ARDS. Hs score calculation see http://saintantoine.aphp.fr/score/
    -Incidence of secondary haemophagocytic lymphohistiocytosis defined by Hs score (Hs score calculation see http://saintantoine.aphp.fr/score/) in relation to serum IL-1 and IL-6
    -Time since randomization until first use of high-flow oxygen devices, non-invasive or invasive mechanical ventilation in non-ventilated patients
    -Time since randomization until first use of salvage systemic steroids in ventilated patients
    -Ventilator-free days over 28 days from inclusion date
    -Duration of mechanical ventilation in ventilated patients
    -Duration of ICU stay in patients that enrolled in trial while already on invasive or non-invasive mechanical ventilation
    -Time to progression to ARDS in ventilated patients
    criteria-defined ARDS (according to the American-European Consensus Conference (AECC) diagnostic criteria for ARDS: acute onset; ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) of 200mmHg or less, regardless of positive end-expiratory pressure; bilateral infiltrates seen on frontal chest radiograph; and pulmonary artery wedge pressure of 18 mm Hg or less when measured, or no clinical evidence of left atrial hypertension)
    -Time to progression to ARDS in ventilated patients according to IL-1 and IL-6
    -All-cause mortality rate at 28 days post inclusion (excluding group that entered during ventilation)
    -Percentage of patients in clinical status on 6-point Ordinal Scale at 10-20 weeks follow up
    -Incidence of lung function abnormalities at 10-20 weeks follow up
    -Incidence of lung fibrosis on chest CT scan at 10-20 weeks follow up
    -All cause mortality at 20 weeks post inclusion for the entire study population
    E.5.2.1Timepoint(s) of evaluation of this end point
    24h
    day 7
    day 15
    28 days after enrolment
    12-20 weeks follow up
    20 weeks post inclusion
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of Care
    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 concerned16
    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 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
    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 months
    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: 171
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 171
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-04. Yes
    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
    If a potential subject ends up in the intensive care unit very quickly after admission, and is mechanically ventilated, permission will be asked from a family member.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state342
    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 Decision2020-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-03
    P. End of Trial
    P.End of Trial StatusOngoing
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