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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2020-001634-36
    Sponsor's Protocol Code Number:SARCOVID
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-001634-36
    A.3Full title of the trial
    Randomized open pilot study to evaluate the efficacy of subcutaneous sarilumab in patients with moderate-severe COVID-19 infection.
    Estudio piloto abierto aleatorizado para evaluar la eficacia de sarilumab subcutáneo en pacientes con infección por COVID-19 moderada-grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized open pilot study to evaluate the efficacy of subcutaneous sarilumab in patients with moderate-severe COVID-19 infection.
    Estudio piloto abierto aleatorizado para evaluar la eficacia de sarilumab subcutáneo en pacientes con infección por COVID-19 moderada-grave.
    A.4.1Sponsor's protocol code numberSARCOVID
    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 SponsorRosario García de Vicuña
    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 supportsANOFI
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRosario García de Vicuña
    B.5.2Functional name of contact pointRosario García de Vicuña
    B.5.3 Address:
    B.5.3.1Street AddressDiego de León 62
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915202473
    B.5.6E-mailmariadelrosario.garcia@salud.madrid.org
    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 Kevzara
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    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 INNSARILUMAB
    D.3.9.1CAS number 1189541-98-7
    D.3.9.4EV Substance CodeSUB177914
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 200
    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 infection requiring hospitalization
    Infección COVID-19 que precisa hospitalización
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection requiring hospitalization
    Infección COVID-19 que precisa hospitalización
    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 evaluate the efficacy of the early administration of sarilumab subcutaneously in patients with moderate-severe COVID-19 infection in early stages compared to the current treatment standard.
    -To compare the baseline clinical and biological parameters, including serum IL-6, of the intervention population against historical controls, to search for possible markers that identify candidates for treatment with subcutaneous IL-6 inhibitors and attempt an approximation to the time frame of “window of opportunity”.
    -Evaluar la eficacia de la administración precoz de sarilumab por vía subcutánea en pacientes con infección COVID-19 moderada-grave en estadios precoces frente al estándar de tratamiento actual.
    -Comparar los parámetros clínicos y biológicos basales, incluida IL-6 sérica, de la población de intervención frente a controles históricos, para buscar posibles marcadores que identifiquen candidatos al tratamiento con inhibidores de IL-6 subcutáneos e intentar una aproximación al marco temporal de “ventana de oportunidad”
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age> 18 years
    2. COVID-19 positive documented by PCR
    3. Documented interstitial pneumonia requiring admission and at least two of the following parameters:
    a. Fever ≥ 37.8ºC in ear
    b. IL-6 in serum ≥ 25 ng / mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg / dL
    c. Lymphocytes <600 mm3
    d. Ferritin> 300 mcg / L that doubles in 24 hours
    e. Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L
    f. D-dimer (> 1 mg / L)
    4. Informed verbal or administration consent under urgent conditions, documented in the medical record.
    1. Edad> 18 años
    2. COVID-19 positivo documentado por PCR
    3. Neumonía intersticial documentada que precise ingreso y al menos dos de los siguientes parámetros:
    a. Fiebre ≥ 37,8ºC en oído
    b. IL-6 en suero ≥ 25 ng/mL (en ausencia de dosis previa de prednisona o equivalente > 1 mg/kg) o PCR >5mg/dL
    c. Linfocitos < 600 mm3
    d. Ferritina >300 mcg/L que se duplica en 24 horas
    e. Ferritina >600 mcg/L en la primera determinación y LDH >250 U/L
    f. D-dímero (>1 mg/L)
    4. Consentimiento informado verbal o de administración en condiciones urgentes, documentado en historia clínica.
    E.4Principal exclusion criteria
    1. Patients who require mechanical ventilation at the time of inclusion.
    2. AST / ALT values greater than 5 times the upper limit of normal.
    3. Neutrophil values below 500 cells / mm3
    4. Platelet values of less than 50,000 cells / mm3
    5. Documented sepsis or high suspicion by pathogens other than COVID-19.
    6. Presence of comorbidities related, according to clinical judgment, with an unfavorable result.
    7. Complicated diverticulitis or intestinal perforation.
    8. Current skin infection (eg, uncontrolled dermopiodermitis).
    9. Immunosuppressive anti-rejection therapy.
    10. Pregnancy or lactation.
    11. Previous treatment with tocilizumab or sarilumab.
    12. Patients participating in some other clinical trial for SARS-CoV-2 infection.
    13. Patients with known hypersensitivity or contraindication to sarilumab or excipients.
    1. Pacientes que requieren ventilación mecánica en el momento de inclusión.
    2. Valores de AST / ALT superiores a 5 veces el límite superior de la normalidad.
    3. Valores de neutrófilos por debajo de 500 células/mm3
    4. Valores de plaquetas de menos de 50.000 células /mm3
    5. Sepsis documentada o alta sospecha por otros patógenos distintos de COVID-19.
    6. Presencia de comorbilidades relacionadas, según el juicio clínico, con un resultado desfavorable.
    7. Diverticulitis complicada o perforación intestinal.
    8. Infección cutánea actual (p. ej., dermopiodermitis no controlada).
    9. Terapia inmunosupresora anti-rechazo.
    10. Embarazo o lactancia.
    11. Tratamiento previo con tocilizumab o sarilumab.
    12. Pacientes participando en algún otro ensayo clínico para infección por SARS-CoV-2.
    13. Pacientes con hipersensibilidad conocida o contraindicación a sarilumab o excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    - Time to become afebrile for a minimum period of 48 hours, without antipyretics
    - Average change in the ordinal scale of 7 points from the inclusion in the study until day 7 (after randomization):
    1. Death
    2. Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    3. Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles.
    4. Hospitalized with oxygen supplement
    5. Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID)
    6. Hospitalized, without oxygen supplement and without the need for continued medical care
    7. Not hospitalized
    - Duration of hospitalization (days)
    - Death
    - Tiempo hasta quedar afebril por un periodo mínimo de 48 horas, sin antipiréticos
    - Cambio medio en la escala ordinal de 7 puntos desde la inclusión en el estudio hasta el día 7 (tras aleatorización)
    1- Muerte
    2- Hospitalizado, con ventilación mecánica u oxigenación por membrana extracorpórea (ECMO).
    3- Hospitalizado, con ventilación mecánica no invasiva, mascarilla con reservorio u oxígeno con gafas nasales de alto flujo.
    4- Hospitalizado con suplemento de oxígeno
    5- Hospitalizado, sin suplemento de oxígeno, pero con necesidad de cuidado médico continuado (en relación o no con COVID)
    6- Hospitalizado, sin suplemento de oxígeno y sin necesidad de cuidado médico continuado
    7- No hospitalizado
    - Duración hospitalización (días)
    - Muerte
    E.5.1.1Timepoint(s) of evaluation of this end point
    The expected duration of subject participation in the trial is until resolution of the COVID-19 infection pattern, approximately 1 month. The overall duration of the study is estimated to be about 2 months, from the recruitment of the first patient to the end of the follow-up of the last patient included. The duration can be shortened if the current rate of income is maintained for at least one month.
    La duración esperada de la participación de los sujetos en el ensayo es hasta la resolución del cuadro de infección por COVID-19, aproximadamente 1 mes. La duración global del estudio se estima en unos 2 meses, desde el reclutamiento del primer paciente hasta la finalización del seguimiento del último paciente incluido. La duración puede acortarse si el ritmo de ingresos actual se mantiene durante al menos un mes.
    E.5.2Secondary end point(s)
    - Time to become afebrile for a minimum period of 48 hours, without antipyretics
    - Time to non-invasive mechanical ventilation (days)
    - Time to invasive mechanical ventilation (days)
    - Time to withdraw oxygen therapy (days)
    - Average change in the ordinal scale of 7 points from the inclusion in the study until day 14 (after randomization):
    1. Death
    2. Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    3. Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles.
    4. Hospitalized with oxygen supplement
    5. Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID)
    6. Hospitalized, without oxygen supplement and without the need for continued medical care
    7. Not hospitalized
    - Tiempo hasta quedar afebril por un periodo mínimo de 48 horas, sin antipiréticos
    - Tiempo hasta ventilación mecánica no invasiva (días)
    - Tiempo hasta ventilación mecánica invasiva (días)
    - Tiempo hasta retirar oxigenoterapia (días)
    - Cambio medio en la escala ordinal de 7 puntos desde la inclusión en el estudio hasta el día 14 (tras aleatorización)
    1- Muerte
    2- Hospitalizado, con ventilación mecánica u oxigenación por membrana extracorpórea (ECMO).
    3- Hospitalizado, con ventilación mecánica no invasiva, mascarilla con reservorio u oxígeno con gafas nasales de alto flujo.
    4- Hospitalizado con suplemento de oxígeno
    5- Hospitalizado, sin suplemento de oxígeno, pero con necesidad de cuidado médico continuado (en relación o no con COVID)
    6- Hospitalizado, sin suplemento de oxígeno y sin necesidad de cuidado médico continuado
    7- No hospitalizado
    E.5.2.1Timepoint(s) of evaluation of this end point
    The expected duration of subject participation in the trial is until resolution of the COVID-19 infection pattern, approximately 1 month. The overall duration of the study is estimated to be about 2 months, from the recruitment of the first patient to the end of the follow-up of the last patient included. The duration can be shortened if the current rate of income is maintained for at least one month.
    La duración esperada de la participación de los sujetos en el ensayo es hasta la resolución del cuadro de infección por COVID-19, aproximadamente 1 mes. La duración global del estudio se estima en unos 2 meses, desde el reclutamiento del primer paciente hasta la finalización del seguimiento del último paciente incluido. La duración puede acortarse si el ritmo de ingresos actual se mantiene durante al menos un mes.
    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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Bajo nivel de intervención
    Low-level intervention trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Última visita del último paciente
    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 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: 30
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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