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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   44334   clinical trials with a EudraCT protocol, of which   7366   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:2021-003246-20
    Sponsor's Protocol Code Number:ENX-CL-03-002
    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:2021-07-27
    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 number2021-003246-20
    A.3Full title of the trial
    A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients with Severe or Critical COVID-19 with Associated Acute Respiratory Distress Syndrome
    Estudio de fase 2b, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de Allocetra-OTS en pacientes con COVID-19 severa o crítica y síndrome de dificultad respiratoria aguda asociado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2b study, conducted in few medical centers, patients will be allocated randomly to receive active drug or placebo. The study will evaluate the efficacy and safety of the drug in patients with respiratory failure due to COVID-19.
    Estudio de fase 2b, realizado en pocos centros médicos, los pacientes serán asignados al azar para recibir un fármaco activo o un placebo. El estudio evaluará la eficacia y seguridad del fármaco en pacientes con insuficiencia respiratoria por COVID-19.
    A.4.1Sponsor's protocol code numberENX-CL-03-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04922957
    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 SponsorEnlivex Therapeutics R&D, Ltd.
    B.1.3.4CountryIsrael
    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 supportEnlivex Therapeutics R&D, Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd.
    B.5.2Functional name of contact pointRegulatory unit
    B.5.3 Address:
    B.5.3.1Street Address103 Haros Str
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1222
    B.5.3.4CountryHungary
    B.5.4Telephone number+3612990091
    B.5.5Fax number+381216503380
    B.5.6E-mailregulatory@accelsiors.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 nameAllocetra-OTS cells in Ringer's Lactate Solution
    D.3.4Pharmaceutical form 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 INNallogeneic peripheral blood mononuclear cells induced to apoptotic state
    D.3.9.3Other descriptive nameAllogeneic peripheral blood mononuclear cells induced to apoptotic state
    D.3.9.4EV Substance CodeSUB199514
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 placeboSolution for infusion
    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
    Infection with the new Coronavirus
    Infección con el nuevo Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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 assess the effect of Allocetra-OTS on ventilation-free survival and recovery in the treatment of COVID-19 patients
    Evaluar el efecto de Allocetra-OTS en la supervivencia sin ventilación y la recuperación en el tratamiento de los pacientes con COVID-19
    E.2.2Secondary objectives of the trial
    To assess additional efficacy parameters and the safety of Allocetra-OTS in the treatment of COVID-19 patients
    Evaluar los parámetros adicionales de eficacia y la seguridad de Allocetra-OTS en el tratamiento de los pacientes con COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female >18 and <85 years of age.
    2. Laboratory confirmation of SARS-CoV-2 infection by reverse transcription polymerase chain reaction from any diagnostic sampling source.
    3. Patient hospitalized due to COVID-19 within 7 days prior to enrollment, meeting the criteria for severe or critical COVID-19
    4. Patient with mild to moderate ARDS:
    5. Signed written informed consent by the patient.
    6. Women and men who are of childbearing potential, willing to use acceptable contraceptive measures during 4 weeks from enrollment.
    1.Hombre o mujer > 18 años y < 85 años de edad.
    2. Confirmación analítica de infección por SARS-CoV-2 mediante reacción en cadena de la polimerasa con retrotranscripción (RT PCR).
    3. Hospitalización del paciente por COVID-19 en los 7 días previos a la inclusión, que cumpla los criterios de COVID-19 critica o severa definidas de la forma siguiente:
    COVID-19 severa - definida como disnea en reposos o dificultad respiratoria o FR ≥ 30 respiraciones/minuto o SpO2 ≤ 93% respirando aire ambiente al nivel del mar.
    COVID-19 crítica - definida como insuficiencia respiratoria que requiere al menos una de las siguientes intervenciones: aporte de oxígeno mediante cánula nasal de alto flujo o ventilación no invasiva con presión positiva.
    4. Pacientes con SDRA leve o moderado:
    • 100 < PaO2/FiO2 ≤ 300; basado en la definición de Berlín del SDRA
    • 148 < SpO2/FiO2 ≤ 315; basado en la modificación de Kigali para el SDRA
    * Si está disponible, se obtendrá la PaO2; en caso contrario, se utilizará la SpO2 para evaluar el SDRA.
    5. Firma del formulario de consentimiento informado por el paciente.
    6. Las mujeres y hombres en edad fértil deben utilizar métodos anticonceptivos aceptables durante 4 semanas a partir de la inclusión.
    E.4Principal exclusion criteria
    1. Patient on IMV/ECMO.
    2. Woman who is pregnant or breastfeeding.
    3. Patient with weight <50 kg or >120 kg or BMI >40 kg/m2.
    4. Patient with stage 4 or 5 chronic kidney disease or estimated glomerular filtration rate <30 mL/min.
    5. Patient with an active malignant tumor (diagnosed or on active treatment for the past 6 months).
    6. Patient who is participating in other concurrent interventional clinical trials or have been treated with any experimental agents within 30 days prior to enrollment.
    7. Patient who based on their medical history and receipt of therapies that would suggest infection, has suspected serious, active bacterial (including a suspected clinical diagnosis of current active tuberculosis [TB] or, if known, latent TB treated for less than 4 weeks with appropriate anti-TB therapy per institutional guidelines), fungal, or viral (including, but not limited to, active HBV, HCV, or HIV/AIDS) infection.
    8. Patient with known immunocompromised state or immunosuppressive medications taken for indications other than SARS-CoV-2 as follows:
    a. Prednisone or equivalent to a dose >10 mg/day, methotrexate >15 mg/week, within the last 60 days; cyclophosphamide, cyclosporine A (unless as ophthalmic formulation), leflunomide/teriflunomide (unless as monotherapy), tacrolimus (unless as a topical formulation), everolimus, temsirolimus, or azathioprine, in the last 60 days;
    b. Methylprednisolone, dexamethasone, cortisone, or betamethasone for more than 7 days within the last 28 days or within 5 half-lives, whichever is longer;
    c. Chemotherapy in the last 3 months;
    d. Mycophenolate mofetil or sirolimus for solid organ transplant or bone marrow transplant;
    e. Thalidomide within the last 72 hours;
    f. Anti-tumor necrosis factor (TNF) agents, interleukin (IL)-1 receptor antagonists, CTLA-4 fusion proteins, anti-CD20, anti-CD52, anti-IL-2, anti-IL-6R, anti-IL-12/23, anti-B-cell activation factor (BAFF) or integrin inhibitor agents within the last 8 weeks.
    9. Patient with known New York Heart Association (NYHA) class III and IV heart failure or unstable angina, ventricular arrhythmias, ischemic heart disease, or myocardial infarction within 6 months prior to diagnosis of COVID-19.
    10. Patient with known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to biopsy-proven cirrhosis; end-stage cirrhosis (Child Pugh Class C); portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
    11. Patient with known idiopathic pulmonary fibrosis.
    12. Patient with chronic respiratory disease requiring home oxygen therapy on a regular basis for more than 6 hours per day.
    13. Patient with known chronic obstructive pulmonary disease GOLD 4 (forced expiratory volume in one second <30% predicted).
    14. Patient with any medical, psychiatric or substance abuse condition, concurrent medical therapies, or abnormal laboratory values that in the opinion of the site Investigator may be of greater safety risk, influence response to study product, or interfere with the study assessments.
    15. Patient with Glasgow Coma Scale <13 with verbal score <5.
    16. Patient with hemoglobin <8 g/dL.
    17. Patient with history of chronic liver disease, evidence of acute cholangitis or cholecystitis. Patients with at least one of the following:
    • Alanine transaminase (ALT) or aspartate transaminase
    (AST) >10×ULN (upper limit of normal)
    • Bilirubin >5×ULN
    • Combination of ALT/AST >7×ULN and elevated direct bilirubin >ULN
    18. Patient with known history of transfusion reactions, hemolytic anemia, or repetitive allergic reaction.
    19. Patient with previous history of organ allograft or stem cell transplantation.
    1. Pacientes con VMI/OMEC.
    2. Mujeres embarazadas o en periodo de lactancia.
    3. Pacientes de < 50 kg o > 120 kg de peso o con un IMC > 40 kg/m2.
    4. Pacientes con insuficiencia renal crónica en estadio 4 o 5 o con una tasa de filtración glomerular < 30 ml/min.
    5. Pacientes con un tumor maligno activo (diagnosticado o en tratamiento activo durante los últimos 6 meses).
    6. Pacientes que participen al mismo tiempo en otros ensayos clínicos intervencionales o que hayan sido tratados con cualquier producto experimental en los 30 días previos a la inclusión.
    7. Pacientes en los que, según su historial y la recepción de tratamientos para posibles infecciones, se sospeche una infección bacteriana (incluido un diagnóstico clínico de tuberculosis [TB] activa actual sospechada o, si se conoce, TB latente tratada durante menos de 4 semanas con la terapia antituberculosa adecuada según las directrices de la institución), fúngica o vírica (incluyendo, entre otras, VHB, VHC o VIH/SIDA) activa grave.
    8. Paciente inmunodeprimido o en tratamiento inmunosupresor para otras indicaciones que no sean el SARS-CoV-2, como sigue:
    a. Prednisona o equivalente a una dosis > 10 mg/día, metotrexato > 15 mg/semana, en los últimos 60 días; ciclofosfamida, ciclosporina A (excepto en formulaciones oftálmicas), leflunomida/teriflunomida (excepto en monoterapia), tacrolimus (excepto en formulaciones tópicas), everolimus, temsirolimus o azatioprina, en los últimos 60 días.
    b. Metilprednisolona, dexametasona, cortisona o betametasona durante más de 7 días en los últimos 28 días o en 5 semividas, lo que sea más largo.
    c. Quimioterapia en los últimos 3 meses.
    d. Micofenolato de mofetilo o sirolimus para el trasplante de órganos sólidos o el trasplante de médula ósea.
    e. Talidomida en las últimas 72 horas.
    f. Inhibidores del factor de necrosis tumoral (anti-TNF), antagonistas de los receptores de interleucina 1 (IL-1), proteínas de fusión CTLA-4, anti-CD20, anti-CD52, anti-IL-2, anti-IL-6R, anti-IL-12/23, inhibidores del factor de activación de linfocitos B (anti-BAFF) o inhibidores de la integrina en las últimas 8 semanas.
    E.5 End points
    E.5.1Primary end point(s)
    A primary composite endpoint will be assessed, as compared to placebo, separately for the two study subpopulations (severely ill and critically ill patients):
    - Time (days) to improvement, defined as the first day, during the period of 28 days post study treatment administration, when a patient reached the score of 6, 7 or 8 on the 8-point ordinal scale.
    If no improvement is reached by Day 28, the patient will be assigned a maximal score of 29.
    - Support by invasive mechanical ventilation (IMV)/ECMO. If required during the period of 28 days post study treatment administration, a patient will be assigned the maximal score of 29.
    - Mortality by Day 28 post study treatment administration. Deceased patients will be assigned the maximal score of 29.
    Se utilizará un criterio de valoración principal compuesto que evaluará de forma separada a las dos subpoblaciones del estudio (pacientes con enfermedad severa y crítica) en comparación con placebo.
    • Tiempo (días) hasta la mejoría, definido como el primer día, durante el periodo de 28 días posterior a la administración del tratamiento del estudio, en que un paciente alcance la puntuación de 6, 7 u 8 en la escala ordinal de 8 puntos. Si el día 28 no se ha logrado ninguna mejoría, se asignará al paciente una puntuación máxima de 29.
    • Soporte vital mediante ventilación mecánica invasiva (VMI)/OMEC. Si es necesario, durante el periodo de 28 días posteriores a la administración del tratamiento del estudio, se asignará al paciente la puntuación máxima de 29.
    • Mortalidad el día 28 posterior a la administración del tratamiento del estudio.
    A los pacientes fallecidos se les asigna la puntuación máxima de 29.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 dias
    E.5.2Secondary end point(s)
    - Time (days) to improvement, defined as the first day, during a period of 28 days and 60 days post study treatment administration, when the patient reached the score of 6, 7 or 8 on the 8-point ordinal scale.
    - All-cause mortality during the period of 28 days and 60 days.
    - Proportion of patients alive and free of respiratory failure, defined as need for IMV, ECMO, noninvasive ventilation, or high-flow nasal cannula oxygen delivery on Days 28 and 60.
    - Cumulative number of vasopressor-free days during the period of 28 days and 60 days.
    - Cumulative number of days in the hospital during the period of 28 days and 60 days.
    - Cumulative number of days in the Intensive Care Unit (ICU) or Intermediate Care Unit (IMU) during the period of 28 days and 60 days.
    • Tiempo (días) hasta la mejoría, definido como el primer día, durante el periodo de 28 días y de 60 días posterior a la administración del tratamiento del estudio, en que un paciente alcance la puntuación de 6, 7 u 8 en la escala ordinal de 8 puntos.
    • Mortalidad por cualquier causa durante el periodo de 28 días y de 60 días.
    • Proporción de pacientes vivos y sin insuficiencia respiratoria, definida como necesidad de VMI, OMEC, ventilación no invasiva o aporte de oxígeno mediante cánula nasal de alto flujo los días 28 y 60.
    • Número acumulado de días sin vasopresores durante el periodo de 28 días y de 60 días.
    • Número acumulado de días en el hospital durante el periodo de 28 días y de 60 días.
    • Número acumulado de días en la Unidad de Cuidados Intensivos (UCI) o en la Unidad de Cuidados Intermedios (UCIM) durante el periodo de 28 días y de 60 días.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days and 60 days
    28 dias y 60 dias
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Israel
    Germany
    Spain
    Greece
    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
    LSLV
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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
    Some subjects may be in a medical condition in which they will not be able to give consent.Legal representative may provide consent on behalf, or a delayed consent process will be performed, in a matter that fully complies with local CA requirements.
    Algunos sujetos pueden estar en una condición médica que no podrán dar su consentimiento. Un representante legal puede dar su consentimiento en su nombre, o se procedería con el proceso de consentimiento retrasado, cumpliendo con la legislación local
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 152
    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)
    No additional treatment or follow up is planned following study end.
    No se prevé ningún tratamiento o seguimiento adicional después de la finalización del estudio.
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-16
    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.

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