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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:2020-001504-42
    Sponsor's Protocol Code Number:MOT-C-204
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-05
    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 number2020-001504-42
    A.3Full title of the trial
    Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients with ventiLatory support (ESSENTIAL). A randomized, double-blind, placebo-controlled study with adaptive features
    Estudio de eficacia y seguridad para evaluar el tratamiento con nangibotida en pacientes con COVID-19 con ventilación asistida (ESSENTIAL). Estudio aleatorizado, doble ciego, controlado con placebo y con características adaptativas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy, safety and tolerability of Nangibotide in patients with Covid-19.
    Estudio para evaluar la eficacia, la seguridad y la tolerabilidad de nangibotida en pacientes con COVID-19
    A.4.1Sponsor's protocol code numberMOT-C-204
    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 SponsorINOTREM S.A.
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportINOTREM S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINOTREM S.A.
    B.5.2Functional name of contact pointValérie Cuvier-Project Manager
    B.5.3 Address:
    B.5.3.1Street Address54 rue de Ponthieu
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33966 81 7900
    B.5.6E-mailcovtrem@inotrem.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 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 nameNangibotide
    D.3.4Pharmaceutical form Lyophilisate 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 INNNangibotide
    D.3.9.1CAS number 2014384-91-7
    D.3.9.3Other descriptive nameLR12
    D.3.9.4EV Substance CodeSUB180844
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 placeboLyophilisate and solvent for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 impact of nangibotide on the progression of disease in patients receiving ventilatory support due to Covid-19
    Evaluar el impacto de la nangibotida en la progresión de la enfermedad en pacientes que reciben ventilación asistida debido a la COVID-19
    E.2.2Secondary objectives of the trial
    • To evaluate the effects of nangibotide exposure over 5 days in patients with Covid-19
    • To evaluate the effect of nangibotide on clinical parameters
    • To evaluate the safety and tolerability of nangibotide in patients with COVID-19
    • To evaluate PD relationship to TREM-1 pathway related markers
    • To evaluate the natural history of the disease regarding the activation of the TREM-1 pathways measured by soluble TREM-1 serum concentrations over time
    • Evaluar los efectos de la exposición a nangibotida durante 5 días en pacientes con COVID-19
    • Evaluar el efecto de nangibotida en los parámetros clínicos
    • Evaluar la seguridad y tolerabilidad de nangibotida en pacientes con COVID-19
    • Evaluar la relación farmacodinámica con los marcadores relacionados con la vía TREM-1
    • Evaluar la historia natural de la enfermedad respecto a la activación de la vía TREM-1 medida por las concentraciones plasmáticas de TREM-1 soluble a lo largo del tiempo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent (emergency consent according to local regulations where approved)
    2. Age 18 to 75 years (inclusive)
    3. Admitted to an intensive care unit
    4. Treatment with High Flow Nasal Oxygen, non-invasive ventilation or invasive mechanical ventilation for acute respiratory failure caused by COVID-19 for less than 48 hours
    5. A PaO2:FiO2 ratio of <200mmHg (<26.7kPa) with a FiO2 ≥0.6
    6. Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria
    1. Haber proporcionado el consentimiento informado (consentimiento de emergencia de acuerdo con la normativa local si está aprobado)
    2. Edad entre 18 y 75 años (inclusive)
    3. Ingresado en una unidad de cuidados intensivos
    4. Tratamiento con oxígeno nasal de alto flujo, ventilación no invasiva o ventilación mecánica invasiva por insuficiencia respiratoria aguda causada por la COVID-19 durante menos de 48 horas
    5. Una relación PaO2:FiO2 de <200 mmHg (<26,7 kPa) con una FiO2 ≥0,6
    6. Diagnóstico de laboratorio confirmado de COVID-19 en un plazo de 7 días de cumplir los criterios de selección
    E.4Principal exclusion criteria
    1. Known pregnancy (positive urine or serum pregnancy test)
    2. Ongoing treatment with an immunomodulatory agent not included in the standard of care for COVID-19 (including participation in clinical trials of such agents)
    3. Body mass index (BMI) ≥ 40 kg/m2 or weight ≥ 130 kg
    4. Anticipated transfer to another hospital, which is not a study site within 72 hours
    5. Expected to die within 6 months of treatment due to underlying chronic disease
    6. Limitations of care in place during current hospital admission
    1. Embarazo conocido (prueba de embarazo positiva en orina o suero)
    2. Tratamiento en curso con un inmunomodulador no incluido en el tratamiento de referencia para la COVID-19 (incluida la participación en ensayos clínicos de dichos inmunomoduladores)
    3. Índice de masa corporal (IMC) ≥40 kg/m2 o peso ≥130 kg
    4. Traslado anticipado a otro hospital, que no sea un centro del estudio en un plazo de 72 horas
    5. Se espera que muera en los 6 meses siguientes al tratamiento debido a una enfermedad crónica subyacente
    6. Limitaciones de atención implementadas durante el ingreso hospitalario actual
    E.5 End points
    E.5.1Primary end point(s)
    • Part 1: The incidence of adverse events and mortality until day 28
    • Part 2: Clinical Status (7-point Ordinal Scale) assessed at Day 28
    • Part 3: All-Cause mortality at day 28
    • Parte 1 (inscripción completa): Incidencia de acontecimientos adversos y mortalidad hasta el día 28
    • Parte 2: Estado clínico evaluado con la escala ordinal de 7 puntos el día 28
    • Parte 3: Mortalidad por todas las causas el día 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Day 28
    Desde el momento basal hasta el día 28.
    E.5.2Secondary end point(s)
    Additional Safety Parameters
    • The incidence of adverse events and mortality until day 28
    • Safety laboratory tests (as part of routine clinical care): hematology, coagulation, plasma biochemistry
    • Adverse events (AEs), serious adverse events (SAEs) and deaths
    • Suspected adverse drug reactions (serious and non-serious)

    Efficacy Parameters
    • Improvement of clinical status on each study day until day 14, at day 28 and at day 60 using an ordinal scale
    • Mortality at day 28
    • PaO2:FiO2 ratio
    • Duration and nature of supported ventilation
    • Incidence of thromboembolic events
    • Incidence of secondary infection
    • Duration and nature of other organ support therapies
    • Functional status and mortality at day 60

    Pharmacodynamics (exploratory)
    sTREM-1, inflammatory exploratory biomarkers
    Parámetros de seguridad adicionales
    • Incidencia de acontecimientos adversos y mortalidad hasta el día 28
    • Análisis de laboratorio de seguridad (como parte de la atención clínica de rutina): hematología, coagulación, bioquímica en plasma
    • Acontecimientos adversos (AA), acontecimientos adversos graves (AAG) y muertes
    • Sospechas de reacciones adversas al medicamento (tanto graves como no graves)

    Parámetros de eficacia
    • Mejoría del estado clínico cada día del estudio hasta el día 14, el día 28 y el día 60 utilizando una escala ordinal
    • Mortalidad el día 28
    • Relación PaO2:FiO2
    • Duración y naturaleza de la ventilación asistida
    • Incidencia de acontecimientos tromboembólicos
    • Incidencia de infección secundaria
    • Duración y naturaleza de otras terapias de soporte a órganos
    • Estado funcional y mortalidad el día 60

    Farmacodinámica (exploratoria)
    sTREM-1, biomarcadores exploratorios de inflamación
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Day 60
    Desde el momento basal hasta el día 60
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    United States
    Belgium
    France
    Spain
    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
    The end of study is defined as the last patient, last visit (LPLV).
    Último paciente última visita.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 241
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 489
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Mechanically-ventilated patients
    Pacientes con ventilación asistida.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 409
    F.4.2.2In the whole clinical trial 730
    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)
    Standard of care will be implemented according to patient's condition at the end of the trial.
    El estándar de cuidado será implementado al final del estudio de acuerdo con la condición del paciente.
    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 Decision2021-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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