Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-003603-33
    Sponsor's Protocol Code Number:SIGMA4COVID
    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:2020-10-16
    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 number2020-003603-33
    A.3Full title of the trial
    Efficacy of E-52862 in the early treatment of confirmed mild symptomatic COVID-19 patients
    Eficacia de E-52862 en el tratamiento temprano de pacientes con síntomas leves de COVID-19 confirmados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of E-52862 in the early treatment of confirmed COVID-19 patients
    Eficacia de E-52862 en el tratamiento temprano de pacientes con COVID-19
    A.4.1Sponsor's protocol code numberSIGMA4COVID
    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 SponsorConsorci Mar Parc de Salut de Barcelona
    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 supportConsorci Mar Parc de Salut de Barcelona
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital del Mar
    B.5.2Functional name of contact pointJordi Monfort Faure
    B.5.3 Address:
    B.5.3.1Street AddressPaseo Marítimo 25-29
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number3493248 33 32
    B.5.6E-mailJMonfort@parcdesalutmar.cat
    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 No
    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 nameE-52862
    D.3.2Product code MR309
    D.3.4Pharmaceutical form Capsule
    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 INNNone registered
    D.3.9.1CAS number 1265917-14-3
    D.3.9.2Current sponsor codeE-52862
    D.3.9.3Other descriptive nameMR309
    D.3.9.4EV Substance CodeSUB31058
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number443.22
    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 placeboCapsule, hard
    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
    Patients with mild COVID-19 disease
    Pacientes con síntomas leves de COVID-19
    E.1.1.1Medical condition in easily understood language
    confirmed COVID-19 patients
    pacientes confirmados por 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 study the evolution of viral load in mild symptomatic patients with confirmed COVID-19.
    Estudiar la evolución de la carga viral en pacientes sintomáticos leves con COVID-19 confirmado.
    E.2.2Secondary objectives of the trial
    1. To study the clinical evolution of the confirmed COVID-19 patients.
    2. Control the adherence to the treatment.
    3. To identify the safety and tolerability of the drug in these patients.
    1. Estudiar la evolución clínica de los pacientes confirmados con COVID-19.
    2. Controlar la adherencia al tratamiento.
    3. Identificar la seguridad y la tolerabilidad del medicamento en estos pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult male and female patients
    2. Patients with mild COVID-19 disease: symptomatic patients without evidence of viral pneumonia or hypoxia (WHO criteria)
    3. Positive PCR SARS-CoV-2 test
    4. Male and female subjects must agree to use acceptable methods of contraception
    1. Pacientes adultos, hombres y mujeres.
    2. Pacientes con enfermedad leve por COVID-19: pacientes sintomáticos sin evidencia de neumonía viral o hipoxia (criterios de la OMS)
    3. Prueba positiva de PCR a SARS-CoV-2
    4. Los sujetos masculinos y femeninos deben aceptar utilizar métodos anticonceptivos aceptables.
    E.4Principal exclusion criteria
    Patients who, in the opinion of the clinician, present:
    1. Hospital admission criteria
    2. Severe dyspnea, and/or fever higher than 38 degrees (ºC) for > 4 days, and/or confirmed pneumonia.
    3. Decompensated pulmonary disease or in treatment for current pulmonary disease
    4. In the absence of previous pulmonary disease, Oxygen saturation ≤ 95 estimated by using the Roth test (Annex 19.4).
    5. In patients with previous pulmonary disease (Oxygen saturation between 90-95%) oxygen saturation ≤ 90% estimated by pulse oximeter
    6. Decompensated Diabetes mellitus and / or decompensated HT
    7. Patients with the following laboratory values abnormalities:
    • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and
    gammaglutamil transpeptidase (GGT) > 2 x ULN (Upper Limit Normality)
    • Neutrophils < 1500/mm3
    • Lymphocytes < 1000/ mm3
    • Haemoglobin < 10 g/dL
    • Platelets < 100.000 / mm3
    • Prothrombin time: > 1.25 x ULN
    • Creatinine clearance according to the Cockroft-Gault equation: < 70 mL/min
    • Any other laboratory abnormality that is judged by the investigator to be clinically relevant
    8. Active infections like HIV, HCV, HBV, TBC.
    9. Patients in treatment with antivirals and/or antiretrovirals.
    10. Serious or unstable cardiovascular disease that could compromise participation or cause hospitalization during the study
    11. Second or third degree atrioventricular blockade not corrected with a pacemaker or any clinically significant abnormality in the 12 lead electrocardiogram as determined by the investigator
    12. Pregnant women or breastfeeding
    13. Any other medical condition that, in the investigator's opinion, could interfere with the validity of the results
    14. Patients undergoing current oncologic treatment, including patients with antiemetic treatment with 5-HT3 inhibitors antagonists for nausea and vomiting induced by chemotherapy
    15. Major psychiatric disorder or/and history of drug abuse or dependence (drug categories defined by Diagnostic and Statistical Manual of Mental Disorders [DSM IV]) within the past year, excluding nicotine and caffeine
    16. Patients in treatment with antipsychotics and/or certain antidepressants (tricyclic antidepressants)
    17. Patients receiving any antimalarial treatment
    Pacientes que, en opinión del clínico, presentan:
    1. Criterios de ingreso hospitalario
    2. Disnea severa y/o fiebre superior a 38 grados celsius durante > 4 días, y/o neumonía confirmada.
    3. Enfermedad pulmonar descompensada o en tratamiento para la enfermedad pulmonar actual
    4. En ausencia de enfermedad pulmonar previa, saturación de oxígeno ≤ 95 estimada mediante la prueba de Roth
    5. En pacientes con enfermedad pulmonar previa (saturación de oxígeno entre 90-95%) saturación de oxígeno ≤ 90% estimado por oxímetro de pulso
    6. Diabetes mellitus descompensada y / o HT descompensada
    7. Pacientes con las siguientes anormalidades en los valores de laboratorio:
    • Alanina aminotransferasa (ALT), aspartato aminotransferasa (AST) y gamma-glutamil transpeptidasa (GGT)> 2 x ULN (límite superior de la normalidad)
    • Neutrófilos <1500 / mm3
    • Linfocitos <1000 / mm3
    • Hemoglobina <10 g / dL
    • Plaquetas <100.000 / mm3
    • Tiempo de protrombina:> 1.25 x ULN
    • Eliminación de creatinina según la ecuación de Cockroft-Gault: <70 ml / min.
    • Cualquier otra anormalidad de laboratorio que el investigador considere clínicamente relevante.
    8. Infecciones activas como VIH, VHC, VHB, TBC.
    9. Pacientes en tratamiento con antivirales y/o antirretrovirales.
    10. Enfermedad cardiovascular grave o inestable que podría comprometer la participación o causar hospitalización durante el estudio.
    11. El bloqueo auriculoventricular de segundo o tercer grado no se corrige con un marcapasos o cualquier anormalidad clínicamente significativa en el electrocardiograma de 12 derivaciones según lo determine el investigador
    12. Mujeres embarazadas o en lactancia
    13. Cualquier otra afección médica que, en opinión del investigador, pueda interferir con la validez de los resultados.
    14. Pacientes sometidos a tratamiento oncológico actual, incluidos los pacientes con tratamiento antiemético con antagonista del receptor 5-HT3 para las náuseas y los vómitos inducidos por la quimioterapia.
    15. Trastorno psiquiátrico mayor y/o antecedentes de abuso o dependencia de drogas (categorías de drogas definidas por el Manual Diagnóstico y Estadístico de los Trastornos Mentales [DSM IV]) en el último año, excluyendo la nicotina y la cafeína
    16. Pacientes en tratamiento con antipsicóticos y/o ciertos antidepresivos (antidepresivos tricíclicos)
    17. Pacientes que reciben algún tratamiento antipalúdico.
    E.5 End points
    E.5.1Primary end point(s)
    Change in SARS-COV-2 viral load from baseline to day 7
    Cambio en la carga viral de SARS-COV-2 desde el basal hasta el día 7
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline and day 7
    basal y día 7
    E.5.2Secondary end point(s)
    1. Change in SARS-COV-2 viral load from baseline to days 4 and 14
    2. Incidence of patients with negative PCR test at days 4, 7 and 14
    3. Time to negative PCR test
    4. Viral load at days 4, 7 and 14
    5. AUC for viral load, time-weighted for patient study duration
    6. Proportion of patients that are recovered during the study and time to clinical recovery (duration and severity of symptoms)
    7. Proportion of deceased patients
    8. Incidence of hospital admissions, incidence of ICU admissions, incidence of mechanical ventilation.
    9. Time-to hospitalization.
    10. Length of hospital stay.
    11. Complications during hospitalization:
    - Hypoxia
    - Low flow oxygen need
    - High flow oxygen need
    - Hypoxemic respiratory failure
    - Hypercapnic respiratory failure
    - Orotracheal intubation
    - Acute kidney failure
    - Need for vasoactive drugs
    - Need for treatment with steroids or biological drugs (e.g., anti-IL-5, anti-IL6, anti-IL-1)
    12. Incidence of consultations to hospital emergencies
    13. Symptoms during telephone monitoring
    14. Concomitant Medications: Incidence and total use during the study
    15. Adverse events stratified for severity using CTCAE
    16. Clinical laboratory parameters, vital signs and ECG in visits
    1. Cambio en la carga viral de SARS-COV-2 desde el basal hasta los días 4 y 14
    2. Incidencia de pacientes con prueba de PCR negativa en los días 4, 7 y 14
    3. Tiempo para la prueba de PCR negativa
    4. Carga viral en los días 4, 7 y 14.
    5. AUC para carga viral, ponderado en el tiempo para la duración del estudio del paciente
    6. Proporción de pacientes que se recuperan durante el estudio y el tiempo de recuperación clínica (duración y gravedad de los síntomas)
    7. Proporción de pacientes fallecidos.
    8. Incidencia de ingresos hospitalarios, incidencia de ingresos en UCI, incidencia de ventilación mecánica.
    9. Tiempo hasta la hospitalización.
    10. Duración de la estancia hospitalaria.
    11. Complicaciones durante la hospitalización:
    - Hipoxia
    - Necesidad de oxígeno de bajo flujo
    - Necesidad de oxígeno de alto flujo
    - Insuficiencia respiratoria hipoxémica
    - Insuficiencia respiratoria hipercápnica
    - intubación orotraqueal
    - Insuficiencia renal aguda
    - Necesidad de drogas vasoactivas
    - Necesidad de tratamiento con esteroides o medicamentos biológicos (por ejemplo, anti-IL-5, anti-IL6, anti-IL-1)
    12. Incidencia de consultas a emergencias hospitalarias.
    13. Síntomas durante la monitorización telefónica.
    14. Medicamentos concomitantes: incidencia y uso total durante el estudio
    15. Eventos adversos estratificados por severidad usando CTCAE
    16. Parámetros de laboratorio clínico, signos vitales y ECG en visitas
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every two days, investigator will contact patients by phone for the next 21 days to register the evolution of symptoms.
    On days 4, 7, 14 and 21, patients should have a face to face visit to assess the clinical evolution of symptoms (including daily record of fever), and to perform the laboratory tests. An oropharyngeal swab RT-PCR test will be performed on days 4, 7 and 14. In the 21-day follow-up visit a standard haematology, coagulation and biochemistry, vital signs assessment and an ECG will be performed.

    A total of 5 clinical visits will be carried out: pre-treatment, +4, +7 and +14 treatment days, and follow-up (day 21).
    Cada dos días, el investigador se comunicará con los pacientes por teléfono durante los próximos 21 días para registrar la evolución de los síntomas.
    Los días 4, 7, 14 y 21, los pacientes deben realizar una visita médica para evaluar la evolución clínica de los síntomas (incluido el registro diario de fiebre) y realizar las pruebas de laboratorio. Se realizará una RT-PCR (muestra nadofaringea) los días 4, 7 y 14. En la visita de seguimiento de 21 días, se realizará un análisis de sangre (hematología estándar, coagulación y bioquímica), evaluación de signos vitales y un ECG.
    Se realizarán un total de 5 visitas clínicas: pretratamiento, +4, +7 y +14 días de tratamiento, y seguimiento (día 21).
    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 Yes
    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 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 No
    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 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 concerned14
    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
    End of the study will be defined as the last completed telephone contact for the last treated subject.
    El final del estudio se definirá como el último contacto telefónico completado para el último sujeto tratado.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state120
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-20
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 13:46:23 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA