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    Summary
    EudraCT Number:2019-003350-80
    Sponsor's Protocol Code Number:APHP190843
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-11-13
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-003350-80
    A.3Full title of the trial
    Lessening Organ Dysfunction with VITamin C (LOVIT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lessening Organ Dysfunction with VITamin C (LOVIT)
    A.3.2Name or abbreviated title of the trial where available
    LOVIT
    A.4.1Sponsor's protocol code numberAPHP190843
    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 SponsorUniversité de Sherbrooke
    B.1.3.4CountryCanada
    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 supportLotte & John Hecht Memorial Foundation
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE HOPITAUX DE PARIS
    B.5.2Functional name of contact pointisabelle vivaldo
    B.5.3 Address:
    B.5.3.1Street AddressDRCI hôpital St louis, 1 avenue claude vellefaux
    B.5.3.2Town/ cityparis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+33140275724
    B.5.6E-mailisabelle.vivaldo@aphp.fr
    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 LAROSCORBINE
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Healthcare (Division Consumer Health)
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAscorbic acid
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 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
    Sepsis
    E.1.1.1Medical condition in easily understood language
    General and serious infection of the body.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    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 effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction – defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors – assessed at 28 days on intensive care unit (ICU) patients.
    E.2.2Secondary objectives of the trial
    To compare the effect of high-dose intravenous vitamin C vs. placebo on:
    1)6-month mortality
    2)6-month HRQoL
    3)organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU)
    4)global tissue dysoxia
    5)occurrence of stage 3 acute kidney injury (KDIGO criteria)
    6)Acute hemolysis as defined by:
    -clinician judgment of hemolysis, as recorded in the chart, OR
    -hemoglobin drop of at least 25 g/L within 24 hours of a dose of IMP + 2 of the following:
    ▪reticulocyte count >2 times upper limit of normal at clinical site lab
    ▪haptoglobin < lower limit of normal at clinical site lab
    ▪Indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab
    ▪Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab
    Severe hemolysis:
    -hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells
    7)hypoglycemia as defined as core lab-validated glucose level < 3.8 mmol/L
    •To assess baseline vitamin C levels
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To ascertain the volume of distribution, clearance, and plasma concentration over a course of 96 hours of intravenous vitamin C 50 mg/kg of weight every 6 hours or matching placebo.
    E.3Principal inclusion criteria
    In both countries:
    1) Patients ≥ 18 years old;
    2) Admitted to the ICU with proven or suspected infection as the main diagnosis;
    3) Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine);

    In France:
    5) Patient (or his representant) who has signed an informed and written consent;
    6) Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU);
    7) Patients under guardianship or curatorship will be included;
    8) Patients in case of simple emergency (legal definition) will be included.
    E.4Principal exclusion criteria
    1) > 24 hours of ICU admission;
    2) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency;
    3) Pregnancy;
    4) Known allergy to vitamin C; or to one of the excipients in particular methyl parahydroxybenzoate (E218) or propyl (E216);
    5) Known kidney stones within the past 1 year;
    6) Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition;
    7) Expected death or withdrawal of life-sustaining treatments within 48 hours;
    8) Previously enrolled in this study;
    9) Previously enrolled in a trial for which co-enrolment is not allowed (co-enrolment to be determined case by case).
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be a composite of death or persistent organ dysfunction (defined as dependency on mechanical ventilation, renal replacement, or vasopressors)
    E.5.1.1Timepoint(s) of evaluation of this end point
    both assessed at 28 days.
    E.5.2Secondary end point(s)
    The secondary outcomes will include:
    1) Persistent organ dysfunction-free days in ICU, up to day 28.
    2) Mortality at 6 months.
    3) HRQoL in 6-month survivors assessed by the EuroQol-5D (EQ-5D). This questionnaire is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale. See Figure 4.
    4) Global tissue dysoxia assessed by serum lactate concentration.24 This will be assessed using liquid chromatography technique coupled with tandem mass
    spectrometry (LC-MS/MS).
    5) Organ function (including renal function) assessed by the SOFA score (Table 1) (days 1, 2, 3, 4, 7, 10, 14, and 28);
    6) Occurrence of stage 3 acute kidney injury as defined by KDIGO criteria18 daily;
    7) Acute hemolysis as diagnosed by the clinical site team (daily);
    8) Hypoglycemia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to day 28.
    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 No
    E.6.6Pharmacokinetic Yes
    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 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 concerned5
    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 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
    Canada
    India
    New Zealand
    Saudi Arabia
    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
    6 months after the last patient being randomized. 6-months after
    randomization, a follow-up call is done to measure quality of life if the
    participant is alive.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 700
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-11-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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
    Surrogate decision maker can give consent for the patient. A deferred consent can also be used.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state153
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 800
    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 Decision2020-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-24
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