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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-001891-14
    Sponsor's Protocol Code Number:Heparin-SARS-CoV2
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-05-05
    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 number2020-001891-14
    A.3Full title of the trial
    Impact of the use of low molecular weight heparins (LMWH), at prophylactic versus intermediate doses, on SARS-CoV2 infection (COVID-19)
    Impacto del uso de heparinas de bajo peso molecular (HBPM), a dosis profiláctica versus intermedia, en la infección por SARS-CoV2 (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of the use of low molecular weight heparins (LMWH), at prophylactic versus intermediate doses, on SARS-CoV2 infection (COVID-19)
    Impacto del uso de heparinas de bajo peso molecular (HBPM), a dosis profiláctica versus intermedia, en la infección por SARS-CoV2 (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    Heparin-SARS-CoV2
    Heparin-SARS-CoV2
    A.4.1Sponsor's protocol code numberHeparin-SARS-CoV2
    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 Neumosur
    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 supportFundación Neumosur
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDelos Clinical
    B.5.2Functional name of contact pointAlejandro
    B.5.3 Address:
    B.5.3.1Street AddressCalle Editor José Manuel Lara, 28, 1B
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34630157890
    B.5.5Fax number+34954308312
    B.5.6E-mailsecretaria@delosclinical.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.2.1.2Country 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 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 9041-08-1
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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
    SARS-CoV-2 coronavirus infection
    Infección por coronavirus SARS-CoV-2
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 assess the impact of treatment with LMWH, using prophylactic versus intermediate doses, in terms of escalation in oxygen therapy or the need for invasive mechanical ventilation or mortality in patients admitted with SARS-CoV2 infection
    Valorar el impacto del tratamiento con HBPM, utilizando dosis profiláctica versus intermedia, en términos de escalada en la oxigenoterapia o necesidad de ventilación mecánica invasiva o mortalidad en pacientes ingresados con infección por SARS-CoV2
    E.2.2Secondary objectives of the trial
    Know the safety of LMWH guideline used in terms of bleeding events, days in hospital and to establish the most favorable patient profile for LMWH treatment.
    Conocer la seguridad de las pautas de HBPM utilizadas en términos de eventos hemorrágicos, días de estancia en el hospital y establecer el perfil de pacientes más favorable al tratamiento con HBPM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients over 18 years old
    2. Signature of informed consent
    3. Diagnosis by positive PCR for SARS-CoV2 infection
    4. They require hospital admission due to fever and other of the established CoV2 admission criteria.
    5. Patients with a weight greater than or equal to 60 Kg.
    1. Pacientes mayores de 18 años
    2. Firma del consentimiento informado
    3. Diagnostico mediante PCR positiva por infección de SARS-CoV2
    4. Requieran ingreso hospitalario por fiebre persistu otros de los criterios de ingreso establecidos CoV2.
    5. Pacientes con peso superior o igual a 60 Kg.
    E.4Principal exclusion criteria
    1. Allergy to LMWH.
    2. Contraindication for anticoagulation (platelets <25 x 10E9 / L or severe active bleeding, major or clinically relevant bleeding)
    3. Pregnancy.
    4. Patients with extreme weights. BMI greater than 40.
    5. Need for chronic anticoagulant treatment.
    6. Need for treatment with high-flow oxygen therapy or mechanical ventilation at the time of study recruitment (within the first 24 hours after admission).
    7. Participation in another disease treatment trial
    venous thromboembolic.
    1. Alergia a HBPM.
    2. Contraindicación para la anticoagulación (plaquetas < 25 x 10E9/L o sangrado activo grave, hemorragia mayor o clínicamente relevante)
    3. Embarazo.
    4. Pacientes con pesos extremos. IMC mayor a 40.
    5. Necesidad de tratamiento anticoagulante crónico.
    6. Necesidad de tratamiento con oxigenoterapia a alto flujo o ventilación mecánica en el momento del reclutamiento en el estudio (dentro de las primeras 24h tras el ingreso).
    7. Participación de otro ensayo de tratamiento de la enfermedad
    tromboembólica venosa.
    E.5 End points
    E.5.1Primary end point(s)
    Need for oxygen therapy escalation due to oxygen saturation (Sat O2) ≤92% with inspired fraction of oxygen (FiO2) ≥0.5 and respiratory rate (FR) ≥30 (IROX index = SatO2 / FiO2] / FR <5.5) or invasive mechanical ventilation or mortality during admission.
    Necesidad de escalada de oxigenoterapia por saturación de oxígeno (Sat O2) ≤92% con fracción inspirada de oxígeno (FiO2) ≥0,5 y frecuencia respiratoria (FR) ≥30 (Indice IROX=SatO2/FiO2]/FR < 5.5) o ventilación mecánica invasiva o mortalidad durante el ingreso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 días
    30 días
    E.5.2Secondary end point(s)
    Need for rescue medication (eg, parenteral corticosteroids, tocilizumab) and days of hospital stay in surviving patients.
    Necesidad de medicación de rescate (ej: corticoides parenterales, tocilizumab) y días de estancia en el hospital en los pacientes que sobreviven.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 días
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Otra pauta
    Another regimen
    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 concerned7
    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
    Last visit of the last subject (LVLS)
    Última visita del último paciente incluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state140
    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)
    The responsible physician will assess the risk / benefit individually to extend or not the prophylaxis
    with enoxaparin 40 mg / sc / day.
    El médico responsable valorará riesgo/beneficio individualizadamente para extender o no la profilaxis
    con enoxaparina 40 mg/sc/día.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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