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    Summary
    EudraCT Number:2020-000855-11
    Sponsor's Protocol Code Number:HJE-STEROHCA-001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-30
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-000855-11
    A.3Full title of the trial
    STEROID TREATMENT AS ANTI-INFLAMMATORY AND NEUROPROTECTIVE AGENT FOLLOWING OUT-OF-HOSPITAL CARDIAC ARREST. A RANDOMIZED TRIAL.
    STEROIDBEHANDLING SOM ANTI-INFLAMMATORISK OG NEUROPROTEKTIV AGENT EFTER HJERTESTOP UDEN FOR HOSPITAL. ET RANDOMISERET STUDIE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    USING STEROID TREATMENT TO INHIBIT INFLAMMATION AND BRAIN INJURY IN PATIENTS RESUSCITATED FROM CARDIAC ARREST.
    BRUG AF STEROIDBEHANDLING TIL AT MINDSKE INFLAMMATION OG HJERNESKADE I GENOPLIVEDE HJERTESTOPSPATIENTER.
    A.3.2Name or abbreviated title of the trial where available
    STEROID TREATMENT FOR OHCA PATIENTS
    STEROIDBEHANDLING TIL GENOPLIVEDE HJERTESTOPSPATIENTER
    A.4.1Sponsor's protocol code numberHJE-STEROHCA-001
    A.5.4Other Identifiers
    Name:The STEROHCA TrialNumber:Acronym
    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 SponsorDepartment of Cardiology, Copenhagen University Hospital Rigshospitalet
    B.1.3.4CountryDenmark
    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 supportCopenhagen University Hospital Rigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital Rigshospitalet
    B.5.2Functional name of contact pointDepartment of Cardiology
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen OE
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535450572
    B.5.6E-mailchristian.hassager@regionh.dk
    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 Solu-Medrol
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer ApS
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameSolu-medrol
    D.3.2Product code 6132
    D.3.4Pharmaceutical form Solution for injection
    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 INNMethylprednisolone
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM SUCCINATE
    D.3.9.4EV Substance CodeSUB14562MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboInfusion
    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
    We investigate the efficacy of commercially available glucocorticoid "methylprednisolone" (Solu-Medrol) for reducing the systemic inflammatory response and neurological injury in patients resuscitated after out-of-hospital cardiac arrest.
    Vi undersøger den antiinflammatoriske og neuroprotektive effekt af det kommercielt tilgængelige glukokortikoid "methylprednisolon" (Solu-Medrol) i patienter genoplivet efter hjertestop uden for hospital.
    E.1.1.1Medical condition in easily understood language
    Patients resuscitated from out-of-hospital cardiac arrest have a high mortality due to a systemic inflammatory response and severe brain injury. We hope that Solu-Medrol can prevent this response.
    Patienter genoplivet efter hjertestop uden for hospital har en høj dødelighed grundet et inflammatorisk respons og svær hjerneskade. Vi håber at Solu-Medrol kan modvirke dette respons.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003109
    E.1.2Term Arrest cardiac
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the efficacy of the glucocorticoid "methylprednisolone" (Solu-Medrol) compared with placebo. The co-primary endpoints being serial measurements of interleukin-6 (IL-6) and neuron-specific-enolase (NSE) at admission and 24, 48 and 72 hours after admission in patients admitted after resuscitated OHCA.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to determine the effects of the glucocorticoid "methylprednisolone" (Solu-Medrol) on inhibition of inflammation, cardiac protection, neuroprotection, renal protection, endothelial protection, clinical endpoints including survival and neurological outcome, as well as safety.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A subset of the trial participants will be enrolled in a sub-study focusing on cardiac-, respiratory and neuroprotection. This sub-study will include an echocardiography, a lung ultrasound, a brain MR-imaging and a cardiac MR-imaging; echocardiography and lung ultrasound will be performed the day following admission, on day 3, 4 or 5 and after three months, MR-imaging will be performed at regained consciousness and after three months. The intervention will be administered exactly as dictated by the main trial. Therefore, participation in a sub-study will have no impact on the IMP use.
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. OHCA of presumed cardiac cause
    3. Unconsciousness (GCS ≤8) upon pre-hospital randomization
    4. Sustained ROSC for at least 5 minutes
    5. Randomization within 30 minutes of sustained ROSC
    E.4Principal exclusion criteria
    1. Advanced life support TOR exclusion criteria
    2. Asystole as primary ECG rhythm
    3. Female of child bearing potential (female aged 15-40, decided by the treating physician)
    4. Known therapy limitation (known decision made of no resuscitation or intensive therapy)
    5. Known allergy to glucocorticoid
    6. Known disease making 180-day survival unlikely
    7. Known pre-arrest modified Rankin Scale (mRS) score of 4-5
    8. Temperature upon admission <30° C
    9. >30 minutes to sustained ROSC
    E.5 End points
    E.5.1Primary end point(s)
    The anti-inflammatory and neuroprotective effect of methylprednisolone decided by measurements of IL-6 and NSE at admission and 24, 48 and 72 hours after admission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At admission and 24, 48 and 72 hours after admission.
    E.5.2Secondary end point(s)
    1. Markers of inflammation: High sensitivity C-reactive protein (hsCRP), leucocyte- and differential count, plasma cytokine levels (IL-1b, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, MCP-1, MIP-1beta, INF-g and tumor-necrosis factor α (TNF-α)) and procalcitonin measured daily the first three days following admission.
    2. Markers of kidney and hepatic injury: Daily creatinine levels the first three days from admission. Daily measurements of ALAT, ASAT, BF, bilirubin and INR the first three days from admission.
    3. Markers of the coagulation system: Plasma fibrinogen the first three days from admission, and thromboelastography at admission and at 48 hours.
    4. Protein and enzymatic protection: Daily proteomics and metabolomics samples the first three days from admission.
    5. Hemodynamics: Daily evaluation by Swan-Ganz catheter, bihourly analyses of arterial blood gases the first 36 hours and transthoracic echocardiogram (TTE) measured the day following admission and on either day 3, 4 or 5.
    6. Neuroprotection: Daily measurements of TAU, NFL, NFM, NFH and GFAP levels the first three days from admission. Formation of cerebral edema decided by MR-imaging of the brain after regained consciousness and consent.
    7. Cardiac protection: Daily measurements of TnT, TnI and CKMB levels the first three days from admission. Infarct size decided by MR-imaging after regained consciousness and consent before discharge from the primary hospital.
    8. Respiratory protection: Lung UltraSound (LUS) performed the day following admission and on either day 3, 4 or 5.
    9. Clinical endpoints: Survival and neurological outcome, decided by mRS score after five days, at discharge from the intensive ward and the hospital and further at 30- and 180- days following discharge through telephone interview.
    10. Follow-up at 90 days following discharge in an ambulatory setting: MoCA-score for assessment of cognitive function and patients will be screened for quality of life, anxiety, depression and the return to daily living with their closest relatives.
    11. Safety: Cumulated daily incidence of adverse events the first seven days, including “severe adverse events” and “adverse events with believed relation to the study medicine”.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of paraclinical endpoints (markers of organ dysfunction) up
    to three days after admission.
    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 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 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 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 contact to the subject will be 6 months (+/- 2 weeks) after last randomization.
    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 months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients included in the study will be unconscious after resuscitated out-of-hospital cardiac arrest.
    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)
    Post trial-specific treatment will not take place after the participation has ended. Patients included in the study will undergo clinical follow-up as normal.
    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 Decision2020-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-28
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