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    Summary
    EudraCT Number:2020-001862-12
    Sponsor's Protocol Code Number:s63213
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-001862-12
    A.3Full title of the trial
    Early administration of Vitamin C in patients with sepsis or septic shock in
    emergency departments: a multicentre, double blinded, randomized
    controlled trial: the C-EASIE trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    C-EASIE trial: Vitamin C - Early Administration in Sepsis In the Emergency
    Department
    A.3.2Name or abbreviated title of the trial where available
    The C-EASIE trial.
    A.4.1Sponsor's protocol code numbers63213
    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 SponsorUniversity Hospitals Leuven, Clinical Trial Centre
    B.1.3.4CountryBelgium
    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 supportBelgian Health Care Knowledge Centre (KCE)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven
    B.5.2Functional name of contact pointC-EASIE Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3216343952
    B.5.6E-mailceasie@uzleuven.be
    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 VITAMIN C PANPHARMA 100 mg/ml Active ingredient: Ascorbic Acid
    D.2.1.1.2Name of the Marketing Authorisation holderPANPHARMA GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 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 INNASCORBIC ACID
    D.3.9.3Other descriptive nameAscorbic Acid
    D.3.9.4EV Substance CodeSUB05579MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSolvent for parenteral use
    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 will investigate the potential benefit of early administration of high
    doses of Vitamin C in addition to standard care in patients with sepsis or
    septic shock.
    E.1.1.1Medical condition in easily understood language
    Sepsis and septic shock are potentially life-threatening conditions
    characterized by a deregulated body's response to infection causing
    injury to its own tissues and organs.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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
    The objective of the trial is to evaluate the efficacy of early administration of Vitamin C in addition to the standard of care in
    patients with sepsis or septic shock.
    This will be done by determining the average post-baseline patient SOFA score (on day 1-5 after patient inclusion). The SOFA score is widely employed in daily monitoring of acute morbidity and is an acceptable surrogate marker of efficacy in exploratory trials of novel therapeutic agents in sepsis.
    We aim to proof that through early admission of Vitamin C, patients who present at an early stage of the disease course will get less sick, resulting in a lower max SOFA score. However, administration of Vitamin C in our sickest population might not necessarily reflect in a lower max SOFA score, but rather in faster recovery (higher delta SOFA between 2 points in time). To capture both phenomena, we will look at the average post-baseline SOFA score as primary outcome supported by a maximum SOFA score as secondary outcome
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate other patient oriented outcome measures and cost-effectiveness of Vitamin C.
    o Maximal SOFA score
    o Length of hospital stay (days)
    o Length of ICU stay
    o 28-day mortality
    o Ventilator days during hospital admission
    o Steroid use
    o Total dose of steroids given (d1-d5)
    o Total duration and dosage during admission
    o RRT duration and need during hospital admission
    o EQ-5D-5L health questionnaire at baseline, day 5, day 28 and month 3 in the view of a possible health economic analysis. If the patient's clinical status doesn't allow self-completion, the questionnaire may becompleted by proxy.
    o Time to return to work (if applicable)
    o Changes in creatinine, CRP and sodium over time (d1-5) (part of standard of care).
    o Changes in procalcitonin between d1 and d4
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants eligible for inclusion in this trial must meet all of the
    following criteria:
    1. Patient is ≥ 18 years old.
    2. Patient has a 'suspected infection': this requires the combination of AB administration and body fluid cultures within the first 6 hours after ED presentation.
    3. NEWS score ≥ 5.

    NEWS is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice, when patients present to the hospital. Six simple physiological parameters form the basis of the scoring system: respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness or new confusion and temperature.
    E.4Principal exclusion criteria
    Participants eligible for this trial must not meet any of the following criteria:
    1. Patient (≥18 years old) or legally authorized representative (LAR) didn't provide informed consent. Delayed informed consent can be applied in cases where the patient is critically ill and no LAR is available
    2. AB administration as a single dose or as a prophylactic treatment.
    3. AB administered without an accompanying body fluid culture according to the timeframe (within 6 hours after ED presentation).
    4. 'Do no intubate' or 'comfort measures only' status.
    5. Failure to randomize within 6 hours.
    6. Weight < 45 kg.
    7. Pregnant or breastfeeding.
    8. Allergy for Vitamin C.
    9. Known history of oxalate nephropathy or hyperoxaluria.
    10. Known history of glucose-6-phosphate dehydrogenase deficiency.
    11. Known history of chronic iron overload due to iron storage and other diseases.
    12. The patient is already on IV steroids for a reason other than septic shock.
    13. Proven active COVID-19 infection (positive swab and/or CT scan positive for COVID).
    E.5 End points
    E.5.1Primary end point(s)
    Clinical Severity
    SOFA score:
    o Average post-baseline patient SOFA score (on day 1-5 after patient randomisation).
    o To avoid missing data for deceased patients, the maximum SOFA score of 24 will be assigned to mortality. Missing values for the non-deceased
    patients will be imputed (see statistical analysis plan).
    o The SOFA score is a morbidity/mortality prediction score based on the degree of dysfunction of 6 organ systems: the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.
    Organ scores range from 0 to 4, with the best score being 0 and the worst score being 4. The higher the SOFA score, the higher the likely mortality.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On day 1 to 5 after patient randomisation
    E.5.2Secondary end point(s)
    o 28-day mortality
    o Maximum SOFA score
    o Length of hospital stay
    o Length of ICU stay
    o Vasopressor requirement: total duration and dosage during d1-5
    o RRT duration and need during d1-5
    o Ventilator days during d1-5
    o Total dose of steroids given (d1-d5)
    o Quality of life (EQ-5D-5L)
    o Time to return to work (if applicable)
    o Lab values :
    - Creatinine, CRP and Sodium on d1-5
    - Procalcitonin on d1 and d4
    E.5.2.1Timepoint(s) of evaluation of this end point
    See 5.2.1
    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 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) No
    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 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 concerned8
    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
    LVLS
    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 months9
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects incapable of giving consent linked to their medical condition, in this case sepsis or septic shock.
    Some of these patients are critically ill: confused, comateus or intubated.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    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
    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 Decision2021-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-15
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