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    Summary
    EudraCT Number:2020-004285-19
    Sponsor's Protocol Code Number:NCT04505774
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2020-09-30
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-004285-19
    A.3Full title of the trial
    A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19
    Ensayo multicéntrico, adaptativo, aleatorizado y controlado sobre la seguridad y eficacia de las estrategias antitrombóticas en adultos hospitalizados con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19
    Ensayo multicéntrico, adaptativo, aleatorizado y controlado sobre la seguridad y eficacia de las estrategias antitrombóticas en adultos hospitalizados con COVID-19
    A.3.2Name or abbreviated title of the trial where available
    ACTIV-4 ACUTE (AC-INPT)
    A.4.1Sponsor's protocol code numberNCT04505774
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04505774
    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 SponsorFundación para la investigación biomédica del Hospital Universitario La Paz
    B.1.3.4CountrySpain
    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 supportNational Heart Lung and Blood Institutes (NHLBI), National Institute of Neurological Disorders (NINDS), ACTIV (ACTIV IV)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBHULP
    B.5.2Functional name of contact pointMarina Aparicio
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34912071466
    B.5.5Fax number+34912071466
    B.5.6E-mailmarina.ucicec@gmail.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 Yes
    D.2.1.1.1Trade name CLEXANE
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCLEXANE
    D.3.4Pharmaceutical form Solution for injection/infusion 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 INNEnoxaparin sodium
    D.3.9.1CAS number 9005-49-6
    D.3.9.3Other descriptive nameENOXAPARIN
    D.3.9.4EV Substance CodeSUB21316
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.5 to 2
    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 FRAGMIN
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer, S.L
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for 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 INNDALTEPARIN SODIUM
    D.3.9.3Other descriptive nameDALTEPARIN SODIUM
    D.3.9.4EV Substance CodeSUB11889MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/g unit(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,2
    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 Arixtra
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for 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 INNFONDAPARINUX
    D.3.9.3Other descriptive nameFONDAPARINUX
    D.3.9.4EV Substance CodeSUB25907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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 HEPARINA
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA INVICTA, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPARIN
    D.3.9.1CAS number 9005-49-6
    D.3.9.3Other descriptive nameHEPARIN
    D.3.9.4EV Substance CodeSUB02475MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.3 to 0.7
    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: 5
    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 HEPARINA
    D.2.1.1.2Name of the Marketing Authorisation holderHOSPIRA INVICTA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for 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 INNHEPARIN
    D.3.9.1CAS number 9005-49-6
    D.3.9.3Other descriptive nameHEPARIN
    D.3.9.4EV Substance CodeSUB02475MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15000 to 22500
    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: 6
    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 innohep
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for 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 INNTINZAPARIN
    D.3.9.3Other descriptive nameTINZAPARIN
    D.3.9.4EV Substance CodeSUB16468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/g unit(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,175
    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: 7
    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 innohep
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Solution for 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 INNTINZAPARIN
    D.3.9.3Other descriptive nameTINZAPARIN
    D.3.9.4EV Substance CodeSUB16468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number45000 to 9000
    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
    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
    COVID-19
    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
    To determine the most effective antithrombotic strategy for increasing the number of days free of organ support and reducing death.
    Determinar la estrategia antitrombótica más eficaz para aumentar el número de días libres de soporte de órganos y reducir la muerte.
    E.2.2Secondary objectives of the trial
    To determine the most effective antithrombotic strategy on the composite endpoint of death, deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), ischemic stroke, or other systemic arterial thrombosis (AT).

    To assess the safety of antithrombotic strategies through the endpoint of major bleeding as defined by ISTH.

    To compare the effect of antithrombotic strategies on the endpoint of all-cause mortality in the study population.

    Assessment of efficacy and safety will yield information of the net clinical benefit of different antithrombotic strategies in the study population. It will also yield information on outcomes specific to under- represented minority populations, specifically African- and Hispanic- descent persons.
    Para determinar la estrategia antitrombótica más eficaz en el punto final compuesto de la muerte, trombosis venosa profunda (TVP), embolia pulmonar (EP), infarto de miocardio (MI), accidente cerebrovascular isquémico u otra trombosis arterial sistémica (AT).

    Evaluar la seguridad de las estrategias antitrombóticas a través de la variable de sangrado mayor según lo definido por ISTH.

    Comparar el efecto de las estrategias antitrombóticas en la variable de mortalidad por todas las causas en la población del estudio.

    La evaluación de la eficacia y la seguridad producirá información sobre el beneficio clínico neto de las diferentes estrategias antitrombóticas en la población del estudio. También proporcionará información sobre los resultados específicos de las poblaciones minoritarias subrepresentadas, específicamente las personas de ascendencia africana e hispana.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ≥ 18 years of age
    - Hospitalized for COVID-19*
    - Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
    - Expected to require hospitalization for > 72 hours

    *It is strongly recommended to confirm SARSCoV2 with a positive microbiological test prior to randomization.
    At centers where there is delay in confirming the diagnosis, a sufficiently high clinical suspicion is sufficient to proceed with randomization as long as confirmation is expected within 24 hours.
    - ≥18 años de edad
    - Hospitalizado para COVID-19*
    - Inscrito dentro de las 72 horas de admisión al hospital o 72 horas de prueba COVID positiva
    - Se espera que requiera hospitalización por > 72 horas

    *Se recomienda encarecidamente confirmar SARSCoV2 con una prueba microbiológica positiva antes de la aleatorización.
    En los centros donde hay retraso en la confirmación del diagnóstico, una sospecha clínica suficientemente alta es suficiente para proceder con la aleatorización, siempre y cuando se espera confirmación dentro de las 24 horas.
    E.4Principal exclusion criteria
    - Imminent death
    - Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
    - Pregnancy
    - See arm-specific appendices.
    - Muerte inminente
    - Requisito de ventilación mecánica crónica a través de la traqueotomía antes de la hospitalización.
    - Embarazo
    - Ver apéndices específicos del brazo.
    E.5 End points
    E.5.1Primary end point(s)
    21 Day Organ Support Free Days, which is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ Support is defined as receipt of invasive or non-invasive mechanical ventilation, high flow nasal oxygen, vasopressor therapy, or ECMO support, with death at any time (including beyond 21 days) during the index hospitalization assigned -1 days.
    21 Días libres de soporte de órganos, que se define como el número de días que un paciente está vivo y libre de apoyo de órganos durante los primeros 21 días después de la entrada en el ensayo. El soporte de órganos se define como la recepción de ventilación mecánica invasiva o no invasiva, oxígeno nasal de alto flujo, terapia vasopresora o soporte ECMO, con la muerte en cualquier momento (incluso más allá de 21 días) durante el índice de hospitalización asignado -1 días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    21 days
    21 días
    E.5.2Secondary end point(s)
    Key Secondary Endpoint: A composite endpoint of death, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke during hospitalization or at 28 days after enrollment (whichever is earlier)
    Other Secondary Endpoints:
    -A composite endpoint of death, deep vein thrombosis, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke during hospitalization or at 28 days after enrollment (whichever is earlier)
    -28 Day Hospital free days (non-ICU level patients)
    -28 Day Ventilator-Free Days (ICU level patients)
    -28 Day Vasopressor-Free Days (ICU level patients)
    -28 Day Renal Replacement Free Days
    -Hospital readmission within 28 days
    -Acute kidney injury as defined by KDIGO criteria
    -Deep vein thrombosis
    -Pulmonary embolism
    -Systemic arterial thrombosis or embolism
    -Myocardial infarction
    -Ischemic stroke
    -Use of extracorporeal membrane oxygenation (ECMO) support
    -Mechanical circuit (dialysis or ECMO) thrombosis
    -All-cause mortality at 28 days
    -Organ support free days at 28 days
    -All-cause mortality during initial hospitalization (includes death after 28 days)
    -WHO ordinal scale (peak scale over 28 days, scale at 14 days, and proportion with improvement by at least 2 categories compared to enrollment, at 28 days)
    - All-cause mortality at 90 days
    Criterio de valoración secundario clave: criterio de valoración compuesto de muerte, embolia pulmonar, tromboembolismo arterial sistémico, infarto de miocardio o accidente cerebrovascular isquémico durante la hospitalización o 28 días después de la inscripción (lo que ocurra primero)
    Otros criterios de valoración secundarios:
    -Un criterio de valoración combinado de muerte, trombosis venosa profunda, embolia pulmonar, tromboembolismo arterial sistémico, infarto de miocardio o accidente cerebrovascular isquémico durante la hospitalización o 28 días después de la inscripción (lo que ocurra primero)
    -28 días libres en el hospital de día (pacientes que no pertenecen a la UCI)
    -28 días sin ventilador (pacientes a nivel de UCI)
    -28 días sin vasopresores (pacientes en UCI)
    -28 días Días libres de reemplazo renal
    -Reingreso hospitalario dentro de los 28 días
    -Insuficiencia renal aguda según la definición de los criterios KDIGO
    -La trombosis venosa profunda
    -Embolia pulmonar
    -Trombosis o embolia arterial sistémica
    -Infarto de miocardio
    -Accidente cerebrovascular isquémico
    -Uso de soporte de oxigenación por membrana extracorpórea (ECMO)
    -Trombosis del circuito mecánico (diálisis o ECMO)
    -Mortalidad por todas las causas a los 28 días
    -Organ support días libres a los 28 días
    -Mortalidad por todas las causas durante la hospitalización inicial (incluye la muerte después de 28 días)
    -Escala ordinal de la OMS (escala máxima durante 28 días, escala a los 14 días y proporción con mejora en al menos 2 categorías en comparación con la inscripción, a los 28 días)
    - Mortalidad por todas las causas a los 90 días
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days after enrollment
    28 días tras inclusión
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Diseño adaptativo. Este ensayo puede incorporar un número flexible de intervenciones.
    Adaptative design. his trial may incorporate a flexible number of interventions.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Brazil
    Canada
    United States
    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
    Ultima visita ultimo paciente
    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
    E.8.9.2In all countries concerned by the trial years1
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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
    Critically ill patients with COVID-19 may not have capacity to provide consent. This trial will include participants who have no capacity to consent only if their legal proxy is able to consent on their behalf.
    Es posible que los pacientes críticamente enfermos con COVID-19 no tengan la capacidad para dar su consentimiento. Este ensayo incluirá participantes que no tengan la capacidad de dar su consentimiento solo si su representante legal puede darlo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 3000
    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
    Ninguno
    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 Decision2020-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-13
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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