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    Summary
    EudraCT Number:2021-000492-36
    Sponsor's Protocol Code Number:HOPECOVID-19
    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:2021-04-21
    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 number2021-000492-36
    A.3Full title of the trial
    Home and Outpatients Precocious Eradication of COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Home and Outpatients Precocious Eradication of COVID-19
    A.3.2Name or abbreviated title of the trial where available
    HOPE COVID-19
    A.4.1Sponsor's protocol code numberHOPECOVID-19
    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 SponsorUCLouvain
    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 supportCentre Académique de Médecine Générale (CAMG), UCLouvain, Belgium
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre académique de médecine générale
    B.5.2Functional name of contact point
    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 Siroxyl sans sucre pour adultes 750 mg/15ml solution buvable
    D.2.1.1.2Name of the Marketing Authorisation holderMELISANA N.V
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcarbocysteine
    D.3.9.1CAS number 638-23-3
    D.3.9.2Current sponsor codeHOPE-01-V
    D.3.9.3Other descriptive nameCARBOCISTEINE LYSINE
    D.3.9.4EV Substance CodeSUB01046MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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 placeboSyrup
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084382
    E.1.2Term Coronavirus disease 2019
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Rate, in percent, of subjects in each investigation arm displaying a SARS-CoV-2 RT-PCR Ct count above 34 (>34 cycles) performed on a saliva sample collected at Day 6 of experiment, after full treatment completion.
    E.2.2Secondary objectives of the trial
    1)Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire (daily comparison of the distribution and mean of FLU-PRO score in each investigation arm)
    2)Rate of subjects in each investigation arm displaying a negative viral culture of a nasopharyngeal swab sample collected at Day 3 of experiment
    3)Median time, in days, of viral shedding in the subjects in each investigation arm (time of viral shedding=nb of days in experiment of a saliva sample which RT-PCR Ct count is >34)
    4)Evolution of the daily distribution and mean RT-PCR Ct count compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 to Day 6
    5)Rate of subjects in each investigation arm having reported any kind of adverse events and reactions including specific comparison according to :
    - the organic system they affect, be it encompassed by the table in Appendix 2 or not ;
    - their quality and severity class : AE, SAE, SUSAR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Provided informed consent following an exhaustive and fully-understood information
    - Aged ≥16 years and ≤65 years
    - Does not present any criteria of redirection towards the Emergency Room or towards a direct hospitalization
    - Time from symptom onset (TFSO) ≤48 hours AND tested positive at the Rapid Antigenic Test
    E.4Principal exclusion criteria
    - Pregnancy, breastfeeding, or any woman of child-bearing potential that does not benefit from any proper contraception and whose Last Menstrual Period occurred 20 days ago or more (≥ 20 days).
    - Immunosuppression, whatever the type, including drug-induced cases.
    - COVID-19 requiring hospitalization or redirection towards the Emergency Room.
    - Anti-COVID-19 vaccination, whatever the vaccine, as soon as first dose has been administered.
    - Former COVID-19 infection diagnosed upon positive SARS-CoV-2 RT-PCR test results.

    E.5 End points
    E.5.1Primary end point(s)
    Rate, in percent, of subjects in each investigation arm displaying a SARS-CoV-2 RT-PCR Ct count above 34 (>34 cycles) performed on a saliva sample collected at Day 6 of experiment
    E.5.1.1Timepoint(s) of evaluation of this end point
    after full treatment completion
    E.5.2Secondary end point(s)
    1) Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire, defined by daily comparison (up to and including Day 10 of experiment) of the distribution and mean of FLU-PRO score in each investigation arm, in points.

    2) Rate, in percent, of subjects in each investigation arm displaying a negative viral culture (impossibility to cultivate SARS-CoV-2, see Section 7 for methodology) of a nasopharyngeal swab sample collected at Day 3 of experiment.

    3) Median time, in days, of viral shedding in the subjects in each investigation arm ; time of viral shedding being defined as the number of days in experiment (starting Day 1) up to and not including the first Day of collection of a saliva sample which RT-PCR Ct count is above 34 (>34).

    4) Evolution of the daily distribution and mean RT-PCR Ct count, in number of cycles, compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 included to Day 6 included.


    5) Rate, in percent, of subjects in each investigation arm having reported any kind of adverse events and reactions, either spontaneously or via prospective adverse event investigation (by daily phone calls of the Study Nurse), including specific comparison according to :
    - the organic system they affect, be it encompassed by the table in Appendix 2 or not ;
    - their quality and severity class : Adverse Event (AE), Severe Adverse Event (SAE), Suspected Unexpected Serious Adverse Reaction (SUSAR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)up to and including Day 10 of experiment
    2)at Day 3 of experiment
    3)from Day 1 to Day 6
    4)from Day 1 to Day 6
    5)from Day 1 to Day 10
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years
    E.8.9.1In the Member State concerned months6
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 94
    F.1.3Elderly (>=65 years) No
    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 2021-04-21. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state104
    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)
    After leaving the trial on day 11, the patient will be cared for by his general practicionner,
    which will be provided with all relevant clinical informations that might have been noticed during the trial.
    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 Decision2021-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-06
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