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    Summary
    EudraCT Number:2021-000598-95
    Sponsor's Protocol Code Number:HS-20-674
    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:2021-05-27
    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 number2021-000598-95
    A.3Full title of the trial
    A Phase 2, randomized, double-blind, placebo-controlled, multi-center trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders
    Ensayo de fase II, aleatorizado, doble ciego, controlado con placebo y multicéntrico para evaluar la eficacia y la seguridad de octreotida subcutánea de liberación prolongada (CAM2029) en pacientes con síndrome de dificultad respiratoria aguda (SDRA) causado por COVID-19 u otros trastornos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, randomized, double-blind, placebo-controlled, multi-center trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders
    Ensayo de fase II, aleatorizado, doble ciego, controlado con placebo y multicéntrico para evaluar la eficacia y la seguridad de octreotida subcutánea de liberación prolongada (CAM2029) en pacientes con síndrome de dificultad respiratoria aguda (SDRA) causado por COVID-19 u otros trastornos
    A.4.1Sponsor's protocol code numberHS-20-674
    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 SponsorCamurus AB
    B.1.3.4CountrySweden
    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 supportCamurus AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCamurus AB
    B.5.2Functional name of contact pointClinical Development and Ph.Vig.
    B.5.3 Address:
    B.5.3.1Street AddressIdeon Science Park
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22370
    B.5.3.4CountrySweden
    B.5.4Telephone number46721612534
    B.5.6E-mailregulatory@camurus.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 nameOctreotide subcutaneous depot
    D.3.2Product code CAM2029
    D.3.4Pharmaceutical form Prolonged-release solution for injection
    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 INNoctreotide
    D.3.9.2Current sponsor codeCAM2029
    D.3.9.3Other descriptive nameOCTREOTIDE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB192677
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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 injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders
    síndrome de dificultad respiratoria aguda (SDRA) causado por COVID-19 u otros trastornos
    E.1.1.1Medical condition in easily understood language
    Acute respiratory distress syndrome
    síndrome de dificultad respiratoria aguda
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the treatment effect of CAM2029 versus placebo on respiratory function in patients diagnosed with acute respiratory distress syndrome (ARDS)
    Comparar el efecto del tratamiento con CAM2029 frente a placebo sobre la función respiratoria en pacientes con diagnóstico de síndrome de dificultad respiratoria aguda (SDRA)
    E.2.2Secondary objectives of the trial
    To evaluate the treatment effect of CAM2029 on respiratory function
    To evaluate the treatment effect of CAM2029 on mortality
    To evaluate the treatment effect of CAM2029 on the stay in the hospital
    To evaluate the treatment effect of CAM2029 on the stay in the Intensive Care Unit (ICU)
    To evaluate the impact of CAM2029 on the patient’s clinical status
    To evaluate the treatment effect of CAM2029 on the patient’s disease-specific, health-related quality of life
    To evaluate the treatment effects of CAM2029 on measures of general, physical, mental and psychosocial functioning
    To evaluate the treatment effect of CAM2029 on serum insulin-like growth factor-1 (IGF-1)
    To assess the plasma concentrations of octreotide after administration of CAM2029
    To evaluate the treatment effect of CAM2029 on inflammatory markers
    To evaluate the safety of CAM2029
    Evaluar el efecto del tratamiento con CAM2029 sobre la función respiratoria
    Evaluar el efecto del tratamiento con CAM2029 sobre la mortalidad
    Evaluar el efecto del tratamiento con CAM2029 en la estancia hospitalaria
    Evaluar el efecto del tratamiento con CAM2029 en la estancia en la unidad de cuidados intensivos (UCI)
    Evaluar el impacto de CAM2029 en el estado clínico del paciente
    Evaluar el efecto del tratamiento con CAM2029 sobre la calidad de vida relacionada con la salud específica de la enfermedad del paciente
    Evaluar los efectos del tratamiento con CAM2029 en las medidas de funcionamiento general, físico, mental y psicosocial
    Evaluar el efecto del tratamiento con CAM2029 sobre el factor de crecimiento similar a la insulina tipo 1 (IGF-1) en suero
    Evaluar las concentraciones plasmáticas de octreotida después de la administración de CAM2029
    Evaluar el efecto del tratamiento con CAM2029 sobre los marcadores inflamatorios
    Evaluar la seguridad de CAM2029
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patient, >18 years old at the time of screening
    • ARDS according to the Berlin definition at the time of randomization:
    - PaO2/FiO2 <300 mmHg (<40 kPa) with positive end-expiratory pressure or CPAP > or = 5 cm H2O on Day 1
    - Bilateral lung opacities not fully explained by effusions, lobular/lung collapse, or nodules as determined by chest imaging (X-ray or computed tomography [CT] scan)
    - Respiratory failure not fully explained by cardiac failure or fluid overload
    • Written informed consent provided by the patient (or legally authorized representative) prior to performing any trial related procedures
    • Hombres o mujeres > 18 años de edad en el momento de la selección
    • SDRA según la definición de Berlín en el momento de la aleatorización:
    - PaO2 /FiO2 <300 mmHg (<40 kPa) con presión positiva al final de la espiración o CPAP > o = 5 cm H2O el día 1
    - Opacidades pulmonares bilaterales no explicadas totalmente por derrames, colapso lobular/pulmonar o nódulos, según se determine mediante imágenes diagnósticas del tórax (radiografía o tomografía axial computarizada [TAC])
    - Insuficiencia respiratoria no explicada totalmente por la insuficiencia cardíaca o la sobrecarga de líquidos
    • Consentimiento informado por escrito proporcionado por el paciente (o representante legal) antes de realizar cualquier procedimiento relacionado con el ensayo
    E.4Principal exclusion criteria
    • A candidate for hospice or palliative care
    • Treatment with somatostatin analogue (e.g. octreotide or lanreotide), pasireotide, bromocriptine/cabergoline or pegvisomant in the past 3 months or plans to receive such treatment during the trial period
    • Treatment with chloroquine or hydroxychloroquine in the past 30 days
    • Treatment with concomitant medication(s) with a known risk of Torsades de Pointes within 7 days prior to screening
    • Currently taking part in another interventional clinical trial
    • History of hypersensitivity or allergy to octreotide
    • Evidence of poorly controlled diabetes (hemoglobin A1c > or = 10%) at screening
    • Known history of, or evidence at screening of, QT prolongation, or having other risk factors for Torsades de Pointes according to the Investigator’s judgement
    • Hepatic- or pancreatic-related disorder, including hepatic cirrhosis, viral hepatitis, gallbladder or bile duct disease, acute or chronic pancreatitis or symptomatic cholelithiasis
    • Cardiac disease:
    - Myocardial infarction or coronary artery bypass graft within 6 months, or
    - Ongoing arrhythmias, complete left bundle branch block or high-grade atrioventricular heart block
    • Untreated or uncontrolled hypothyroidism
    • Abnormal liver laboratory parameters at screening: aspartate aminotransferase or alanine aminotransferase > or = 3.0 × upper limit of normal (ULN) combined with total bilirubin >2 × ULN and amylase or lipase > or = 3.0 × ULN
    • Severe renal failure requiring dialysis
    • Malignancy or other irreversible disease or condition for which 6-month mortality is estimated at 50% or more
    • Pre-existing neuromuscular disease impairing spontaneous ventilation
    • Any other serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial
    • Pregnant or lactating women
    • On the staff, affiliated with, or a family member of the personnel directly involved with this trial
    • Candidato para cuidados paliativos
    • Tratamiento con análogo de la somatostatina (p. ej.,octreotida o lanreotida), pasireotida, bromocriptina/cabergolina o pegvisomant en los últimos 3 meses o tiene previsto recibir dicho tratamiento durante el periodo del ensayo
    • Tratamiento con cloroquina o hidroxicloroquina en los últimos 30 días
    • Tratamiento con medicamentos concomitantes con riesgo conocido de Torsades de Pointes en los 7 días previos a la selección
    • Estar participando actualmente en otro ensayo clínico intervencionista
    • Antecedentes de hipersensibilidad o alergia a octreotida
    • Evidencia de diabetes mal controlada (hemoglobina A1c > o = 10 %) en la selección
    • Antecedentes conocidos o indicios en la selección de prolongación del intervalo QT o presencia de otros factores de riesgo de Torsades de Pointes según el criterio del investigador
    • Trastorno hepático o pancreático, incluidas cirrosis hepática, hepatitis vírica, enfermedad de la vesícula biliar o del conducto biliar, pancreatitis aguda o crónica o colelitiasis sintomática
    • Cardiopatía:
    - Infarto de miocardio o injerto de revascularización coronaria en los 6 meses anteriores, o
    - Arritmias en curso, bloqueo de rama izquierda completo o bloqueo cardíaco auriculoventricular de grado alto
    • Hipotiroidismo no tratado o no controlado
    • Parámetros analíticos hepáticos anómalos en la selección: aspartato aminotransferasa o alanina aminotransferasa > o = 3,0 × límite superior de la normalidad (LSN) combinado con bilirrubina total >2 × LSN y amilasa o lipasa > o = 3,0 × LSN
    • Insuficiencia renal grave que requiere diálisis
    • Neoplasia maligna u otra enfermedad o afección irreversible para la que la mortalidad a los 6 meses se estima en el 50 % o más
    • Enfermedad neuromuscular preexistente que afecta a la ventilación espontánea
    • Cualquier otra afección médica grave que, en opinión del investigador, pueda impedir que el paciente participe de forma segura en el ensayo
    • Mujeres embarazadas o en periodo de lactancia
    • Ser miembro del personal, afiliado o familiar del personal directamente implicado en este ensayo
    E.5 End points
    E.5.1Primary end point(s)
    Time to improvement of > or = 2.0 in oxygenation saturation index sustained for at least 48 hours
    Tiempo hasta la mejora de > or = 2,0 en el índice de saturación de oxigenación mantenida durante al menos 48 horas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 (baseline) to Day 84
    día 1 (inicio) hasta el día 84
    E.5.2Secondary end point(s)
    • Time to improvement in oxygenation sustained for at least 48 hours
    • Proportion of patients alive on Day 28 with an improvement of > or = 2.0 in oxygenation saturation index sustained for at least 48 hours
    • Time to improvement of > or = 2.0 in oxygenation index sustained for at least 48 hours
    • Alive, mechanical ventilation-free days
    • Alive, respiratory-failure-free days
    • Proportion of patients who are alive and respiratory-failure-free on Day 28
    • All-cause mortality on Day 28
    • Number of days in the hospital
    • Proportion of patients who are alive and discharged from the hospital on Day 28
    • Number of days in the ICU
    • Proportion of patients who are alive and discharged from the ICU on Day 28
    • Clinical status pattern over time using a modified ordinal scale
    • Saint George’s Respiratory Questionnaire (SGRQ)
    • King’s Brief Interstitial Lung Disease (KBILD)
    • Short Form-36 (SF-36)
    • Hospital Anxiety and Depression Scale (HADS)
    • Change from baseline in the levels of serum IGF-1 and insulin-like growth factor-binding protein 3 (IGFBP-3)
    • Octreotide plasma concentrations over time
    • Change from baseline in the levels of interleukin-6 (IL-6) and C-reactive protein (CRP)
    • Proportion of patients with treatment-emergent severe fatal or life-threatening serious adverse events (SAEs)
    • Proportion of patients with treatment-emergent adverse events (AEs) of special interest
    • Tiempo hasta la mejora de la oxigenaciónb mantenida durante al menos 48 horas
    • Proporción de pacientes vivos el día 28 con una mejora de ≥2,0 en el índice de saturación de oxigenación mantenida durante al menos 48 horas
    • Tiempo hasta la mejora de > o = 2,0 en el índice de oxigenaciónc mantenida durante al menos 48 horas
    • Días con vida sin respirador mecánico
    • Días con vida sin insuficiencia respiratoriad
    • Proporción de pacientes con vida y sin insuficiencia respiratoria el día 28
    • Mortalidad por cualquier causa el día 28
    • Número de días en el hospital
    • Proporción de pacientes vivos y dados de alta del hospital el día 28
    • Número de días en la UCI
    • Proporción de pacientes vivos y dados de alta de la UCI el día 28
    • Patrón de estado clínico a lo largo del tiempo utilizando una escala ordinal modificada
    • Cuestionario respiratorio St. George (St. George Respiratory Questionnaire, SGRQ)
    • Cuestionario breve de enfermedad pulmonar intersticial de King (King’s Brief Interstitial Lung Disease, KBILD)
    • Cuestionario de salud abreviado de 36 ítems (SF-36)
    • Escala de ansiedad y depresión hospitalaria (Hospital Anxiety and Depression Scale, HADS)
    • Cambio con respecto al inicio en los niveles de IGF-1 en suero y de proteína 3 de unión al factor de crecimiento similar a la insulina (IGFBP-3)
    • Concentraciones plasmáticas de octreotida a lo largo del tiempo
    • Cambio con respecto al inicio en los niveles de interleucina-6 (IL-6) y proteína C reactiva (PCR)
    • Proporción de pacientes con acontecimientos adversos graves (AAG) mortales o potencialmente mortales surgidos durante el tratamiento
    • Proporción de pacientes con acontecimientos adversos (AA) surgidos durante el tratamiento de especial interés
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 (baseline) to Day 84
    Day 28
    Baseline to last available assessment
    día 1 (inicio) hasta el día 84
    Día 28
    el inicio hasta la última evaluación disponible
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Italy
    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
    Last protocol-specified contact with last patient ongoing in the trial
    Último contacto especificado por el protocolo con el último paciente en curso en el ensayo
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In case the patient is unable to provide informed consent (e.g. if the patient is in mechanical ventilation) and there is a legal representative, consent must be obtained from the legal representative.
    En caso de que el paciente no pueda dar su consentimiento informado (por ejemplo, si el paciente está en ventilación mecánica) y hay un representante legal, se debe obtener el consentimiento del representante legal.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 40
    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)
    Patient will continue with Best Supportive Care as per local hospital guidelines and routine.
    El paciente continuará con la mejor atención de apoyo según las pautas y la rutina del hospital local.
    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 Decision2021-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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
    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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