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    Summary
    EudraCT Number:2022-001949-20
    Sponsor's Protocol Code Number:1.0
    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:2022-09-29
    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 number2022-001949-20
    A.3Full title of the trial
    Human albumin treatment in adult septic shock. A phase 2, multicenter, randomized, controlled study evaluating the immune response and organ failure.
    Tratamiento de la albúmina humana en el shock séptico del adulto. Un estudio de fase 2, multicéntrico, aleatorizado y controlado que evalúa la respuesta inmune y la insuficiencia orgánica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Human albumin treatment in adult septic shock.
    Tratamiento de la albúmina humana en el shock séptico del adulto.
    A.3.2Name or abbreviated title of the trial where available
    ALBUMIM
    ALBUMIM
    A.4.1Sponsor's protocol code number1.0
    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 SponsorALBIMMUNE S.L.
    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 supportALBIMMUNE S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU clínic
    B.5.2Functional name of contact pointAnna Cruceta
    B.5.3 Address:
    B.5.3.1Street AddressCarrer Mallorca 183
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-mailacruceta@recerca.clinic.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 Yes
    D.2.1.1.1Trade name Albutein
    D.2.1.1.2Name of the Marketing Authorisation holderInstituto Grifols, S.A.
    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 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 INNAlbutein
    D.3.9.1CAS number 70024-90-7
    D.3.9.3Other descriptive nameHuman albumin solution
    D.3.9.4EV Substance CodeSUB12026MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Septic Shock
    Shock Séptico
    E.1.1.1Medical condition in easily understood language
    Serious Infections
    Infecciones graves
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    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
    Evaluate the effect of albumin treatment on B-cell gene expression in patients with septic shock.
    Evaluar el efecto del tratamiento con albúmina sobre la expresión genética de células B en pacientes con shock séptico.
    E.2.2Secondary objectives of the trial
    1. Identify additional biomarkers of B-cell and other immune defense responses, including ex vivo assessment of the functionality of antibody-secreting cells and neutrophils.
    2. To further investigate the mechanisms of action of albumin treatment on B-cell function.
    3. Investigate whether albumin activates B-cells at the mucosal interface.
    4. Evaluate the effect of albumin treatment on systemic inflammation and the incidence of organ dysfunction.
    5. Evaluate the effect of albumin on endothelial and glycocalix function.
    6. Evaluate time of vasopressors, mechanical ventilation and renal replacement therapy.
    7. Evaluate secondary infections at 28 days.
    8. Evaluate mortality at 28 and 90 days, hospital and ICU readmission.
    9. Evaluate quality of life (QoL) at baseline and 90 days.
    10. Evaluate the safety of albumin treatment (SAE, SUSAR, AEs).
    1. Identificar biomarcadores adicionales de células B y otras respuestas de defensa inmunitarias, incluida la evaluación ex vivo de la funcionalidad de las células secretoras de anticuerpos y los neutrófilos.
    2. Investigar más a fondo los mecanismos de acción del tratamiento con albúmina sobre la función de las células B.
    3. Investigar si la albúmina activa las células B en la interfaz de la mucosa.
    4. Evaluar el efecto del tratamiento con albúmina sobre la inflamación sistémica y la incidencia de disfunción orgánica.
    5. Evaluar el efecto de la albúmina sobre la función endotelial y glicocálix.
    6. Evaluar tiempo de vasopresores, ventilación mecánica y terapia de reemplazo renal.
    7. Evaluar infecciones secundarias a los 28 días.
    8. Evaluar mortalidad a 28 y 90 días, reingreso hospitalario y UCI.
    9. Evaluar la calidad de vida (QoL) al inicio ya los 90 días.
    10. Evaluar la seguridad del tratamiento con albúmina (SAE, SUSAR, AE).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 years and <85 years of age.
    2. Community-acquired pneumonia, urinary, skin or biliary infection.
    3. Treatment with antibiotics at least one course in the first 6 hours of suspected infection.
    4. Meets Septic Shock criteria defined by the presence of sepsis with persistent hypotension despite initial adequate volume resuscitation requiring vasopressors for more than 4h to maintain MAP>65 mmHg and having a serum lactate level > 2mmol/L (18mg/L).
    5. SOFA score ≥ 5 points.
    6. Albumin plasma level <35g/L.
    7. Lymphocytes count < 1,100 cel/mL.
    8. Admitted to ICU or IMU
    1. Hombre o mujer ≥ 18 años y <85 años de edad.
    2. Neumonía adquirida en la comunidad, infección urinaria, cutánea o biliar.
    3. Tratamiento con antibióticos de al menos un ciclo en las primeras 6 horas de sospecha de infección.
    4. Cumple con los criterios de Shock Séptico definidos por la presencia de sepsis con hipotensión persistente a pesar de la reanimación inicial adecuada de volumen, que requiere vasopresores durante más de 4h para mantener MAP>65 mmHg y tener un nivel de lactato sérico > 2mmol/L (18mg/L).
    5. Puntuación SOFA ≥ 5 puntos.
    6. Nivel plasmático de albúmina <35g/L.
    7. Recuento de linfocitos < 1.100 cel/ml.
    8. Ingresado en la UCI o IMU.
    E.4Principal exclusion criteria
    1. Septic shock lasting for more than 24h.
    2. ECMO or hemoadsortion therapy.
    3. Contraindications to receive albumin.
    4. Nosocomial or healthcare-associated infections (surgical intervention or hospitalization within 30 days prior to diagnosis of sepsis).
    5. Chronic Renal Failure (KIDGO stage 3-5) or dialysis.
    6. Liver cirrhosis.
    7. A known malignancy that is progressing or has required active treatment within the past 3 months.
    8. Patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live < 6 months (as assessed by the study physician).
    9. Known New York Heart Association (NYHA) class II to IV heart failure or unstable angina, acute coronary disease or myocardial infarction within 6 months prior to diagnosis of sepsis.
    10. Known immunocompromised state, including human immunodeficiency virus infection, or medication known to be immunosuppressive.
    11. Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis.
    12. Likely to be non-compliant or uncooperative during the study (e.g. substance abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with the study).
    13. Albumin administration within the last 14 days.
    14. Subjects with severe neurological or severe head trauma disorders.
    15. Pregnant and/or breast-feeding woman.
    16. Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision marker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
    1. Shock séptico que dura más de 24 horas.
    2. ECMO o terapia de hemoadsorción.
    3. Contraindicaciones para recibir albúmina.
    4. Infecciones nosocomiales o asociadas a la asistencia sanitaria (intervención quirúrgica u hospitalización dentro de los 30 días anteriores al diagnóstico de sepsis).
    5. Insuficiencia renal crónica (KIDGO etapa 3-5) o diálisis.
    6. Cirrosis hepática.
    7. Una neoplasia maligna conocida que está progresando o que ha requerido tratamiento activo en los últimos 3 meses.
    8. Paciente con enfermedad terminal (no relacionada con sepsis) definida como pacientes que antes de la hospitalización actual tengan una esperanza de vida < 6 meses (según lo evaluado por el médico del estudio).
    9. Diagnóstico de insuficiencia cardíaca conocida New York Heart Association (NYHA) clase II a IV o angina inestable, enfermedad coronaria aguda o infarto de miocardio dentro de los 6 meses anteriores al diagnóstico de sepsis.
    10. Estado inmunocomprometido conocido, incluida la infección por el virus de la inmunodeficiencia humana o medicamentos que se sabe que son inmunosupresores.
    11. Participación en un estudio de investigación intervencionista dentro de los 30 días anteriores al diagnóstico de sepsis.
    12. Probabilidad de incumplimiento o no cumplimiento de procedimientos durante el estudio (por ejemplo, abuso de sustancias, trastorno psiquiátrico no controlado o cualquier afección crónica que pueda interferir con el estudio).
    13. Administración de albúmina en los últimos 14 días.
    14. Sujetos con trastornos neurológicos graves o traumatismo craneoencefálico grave.
    15. Mujer embarazada y/o en período de lactancia.
    16. Pacientes que no pueden dar consentimiento informado previo y cuando existen pruebas documentadas de que el paciente no tiene un representante legal y parece poco probable que el paciente recupere la conciencia o capacidad suficiente para proporcionar un consentimiento informado diferido .
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate B cell and other immune cell response to albumin treatment through the Immunology Complex and other Gen Set scores. Scores are based on the expression of 5 to 10 genes that estimate the expression of the whole B-cell and other immune cell transcriptome.
    Evaluar la respuesta de las células B y otras células inmunitarias al tratamiento con albúmina a través del Complejo de inmunología y otras puntuaciones de Gen Set. Las puntuaciones se basan en la expresión de 5 a 10 genes que estiman la expresión de la célula B completa y del transcriptoma de otras células inmunitarias.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of the study participation
    Duración de la participación en el estudio
    E.5.2Secondary end point(s)
    1. Identify additional biomarkers of the immune response to albumin treatment through the scores and evaluate the functionality of antibody-secreting B cells through B cell and neutrophil function, serum immunoglobulin levels, glycosylation and blood immunophenotyping.
    2. To further investigate the mechanisms of albumin treatment on the immune system by assessing:
    - Whole blood RNA sequencing
    - Single–cell RNA sequencing and CITE-seq
    - Immunophenotyping of B cells by high-dimensional spectral flow cytometry
    3. Evaluate whether albumin activates B cells at the mucosal interface through the assessment of circulating levels of immunoglobulins and glycosylated immunoglobulins.
    4.1. Evaluate the effect of albumin treatment on systemic inflammation through the measurement of plasma cytokines: IL-1β, IL-1ra, IL-6, IL-7, IL-8, IL-10, IL-17, TNF-α, TNFr1, IFN-γ, MCP-1, MCP-3, RAGE.
    4.2. Evaluate kidney [sCr, urine output, balance fluid, KDIGO stage 2-3, TIMP-2 and IGFBP 7 (nephrocheck)
    4.3. To explore the effect of albumin on gut mucosa immunoglobulins:
    - Composition of bacterial communities bound to IgA.
    - Composition of whole fecal bacteria.
    - Antibody-binding profile of microbes.
    - Bacterial reactivity of peripheral blood antibodies.
    5. Evaluate the effect of albumin on endothelial and glycocalix function through the measurement of angiopoeitin 1 and 2, MR-proADM, Selectin, VCAM-1, ICAM-1, endothelin-1, thrombomodulin, syndecan 1-4, prot C, heparan sulfate, VEGF, sphingosine-1-phosphate (S1P) and PAI-1.
    6. Time on vasopressors, mechanical ventilation and renal replacement.
    7. Proportion of patients with secondary infections.
    8. Proportion of patients dead at 28 and 90 days, proportion of patients re-admitted to ICU and hospital at 28 days and evaluate the sequential SOFA and APACHE II scores.
    9. Evaluate quality of life (QoL) through the EQ-5D-5L questionnaire at day 90.
    10. Proportion of participants with any AEs related to albumin treatment, SAEs and SUSARs.
    1. Identificar biomarcadores adicionales de la respuesta inmune al tratamiento con albúmina a través de las puntuaciones y evaluar la funcionalidad de las células B secretoras de anticuerpos a través de la función de células B y neutrófilos, niveles de inmunoglobulina sérica, glicosilación e inmunofenotipado sanguíneo.
    2. Investigar más a fondo los mecanismos del tratamiento de la albúmina en el sistema inmunitario mediante la evaluación:
    - Secuenciación de ARN en sangre total
    - Secuenciación de ARN unicelular y CITE-seq
    - Inmunofenotipado de células B por citometría de flujo espectral de alta dimensión
    3. Evaluar si la albúmina activa las células B en la interfaz mucosa a través de la evaluación de los niveles circulantes de inmunoglobulinas e inmunoglobulinas glicosiladas.
    4.1. Evaluar el efecto del tratamiento con albúmina sobre la inflamación sistémica mediante la medición de citoquinas plasmáticas : IL-1β , IL-1ra, IL-6, IL-7, IL-8, IL-10, IL-17, TNF-α, TNFr1, IFN-γ, MCP-1, MCP-3, RABIA.
    4.2. Evaluar función renal [sCr, diuresis , líquido de equilibrio , KDIGO etapa 2-3, TIMP-2 e IGFBP 7 (nefrocontrol)
    4.3. Explorar el efecto de la albúmina sobre las inmunoglobulinas de la mucosa intestinal:
    - Composición de las comunidades bacterianas unidas a IgA.
    - Composición de bacterias fecales enteras.
    - Perfil de unión a anticuerpos de microbios.
    - Reactividad bacteriana de los anticuerpos de sangre periférica.
    5. Evaluar el efecto de la albúmina sobre la función endotelial y glicoccalix mediante la medición de angiopoeitina 1 y 2, MR-proADM, Selectina, VCAM-1, ICAM-1, eendotelina-1, trombomodulina, sindecano 1-4, prot C, heparán sulfato, VEGF, esfingosina-1-fosfato (S1P) y PAI-1.
    6. Tiempo en vasopresores, ventilación mecánica y reemplazo renal.
    7. Proporción de pacientes con infecciones secundarias.
    8. Proporción de pacientes fallecidos a los 28 y 90 días, proporción de pacientes reincorporados a UCI y hospital a los 28 días y evaluación de las puntuaciones secuenciales SOFA y APACHE II.
    9. Evaluar la calidad de vida (CdV) a través del cuestionario EQ-5D-5L en el día 90.
    10. Proporción de participantes con cualquier AE relacionado con el tratamiento de la albúmina, SAEs y SUSARs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 2. 3. 4. 5. 6. and 10. During the study participation
    7. Day 28
    8. Day 28 and 90
    9. Day 90
    1. 2. 3. 4. 5. 6. y 10. Durante la participación en el estudio
    7. Day 28
    8. Días 28 y 90
    9. Día 90
    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 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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Last visit Last Subject
    Última visita del último participante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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
    No
    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 Decision2023-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-02
    P. End of Trial
    P.End of Trial StatusOngoing
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