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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-003366-39
    Sponsor's Protocol Code Number:APHP200702
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-13
    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 number2020-003366-39
    A.3Full title of the trial
    CAMOVID: A multicenter randomized trial to evaluate the efficacy and safety of camostat mesylate for the treatment of SARS-CoV-2 infection in ambulatory adult patients.
    CAMOVID: Etude multicentrique randomisée, pour évaluer l'efficacité et la tolérance du camostat mesylate pour le traitement de l'infection à SARSCoV-2 chez des patients adultes ambulatoires
    A.4.1Sponsor's protocol code numberAPHP200702
    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 SponsorAssitance Publique-Hopiaux de Paris
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    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 FOIPAN 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderOno Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameCamostat mesilate
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNCAMOSTAT MESILATE
    D.3.9.1CAS number 59721-29-8
    D.3.9.4EV Substance CodeSUB01007MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 placeboTablet
    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
    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
    Evaluate the efficacy of camostat mesylate in the treatment of SARS-CoV-2 infection in adult patients with confirmed COVID-19 not requiring initial hospitalization, , in terms of hospitalization needs, up to day 21 after randomization
    Evaluer l’efficacité du camostat mésylate dans le traitement de l’infection à SARS-CoV2 pour des patients adultes avec une maladie COVID-19 confirmée et ne nécessitant pas une hospitalisation initiale, en termes de nécessité d’hospitalisation pour la prise en charge COVID-19, entre J0 et J21.
    E.2.2Secondary objectives of the trial
    - Safety up to day 21
    - Efficacy in terms of need for hospitalization for COVID-19 management, by independent blinded committee review
    - Overall clinical improvement at day 21
    - Clinical efficacy in terms of intensive care needs, up to day 21
    - Clinical efficacy in terms of time to hospitalization, up to day 21
    - Clinical efficacy on respiratory functions, up to day 21
    - Overall survival at day 21 and 90 after randomization
    - Patient-reported outcome on initial symptoms, up to day 21
    - Virological, serological and immunological efficacy, up to day 21
    - Renal complications, up to day 21
    - Liver complications, up to day 14
    - la tolérance du traitement, à 21 jours (J21)
    - l’efficacité en termes de nécessité d’hospitalisation pour la prise en charge COVID-19, selon une évaluation par un comité indépendant en aveugle du groupe de traitement de randomisation
    - l’amélioration clinique globale à J21
    - l’efficacité clinique en termes de recours aux soins intensifs, entre J0 et J21
    - l’efficacité clinique en termes de délai d’hospitalisation, entre J0 et J21
    - l’efficacité clinique en termes d’impact sur la fonction respiratoire, entre J0 et J21
    - la survie globale à J21 et J90 de l’inclusion
    - les symptômes, rapportés par les patients, entre J0 et J21
    - l’efficacité virologique, sérologigue et immunologique entre J0 et J21
    - les complications rénales, entre J0 et J21
    - les complications hépatiques, entre J0 et J21
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age > 18 y.o.
    2) Laboratory confirmed SARS-CoV2 infection with mild COVID-19, fulfilling all the following criteria:
    - Positive SARS-CoV-2 RT-PCR nasal swab samples
    AND
    - Clinical symptoms and signs consistent with SARS-CoV2 infection including but not limited to, fever, upper respiratory tract infection signs, digestive signs, muscle pain, anosmia, dysgeusia…[WHO]
    3) Informed consent to participate to the trial
    4) Patients must be able and willing to comply with study visits and procedures
    1) Age > 18 ans.
    2) Infection SARS-CoV2 confirmée par prélèvement et modérée:
    - RT-PCR positive à SARS-CoV-2 par écouvillonnage nasal
    ET
    - symptômes et signes cliniques d’infection SARS-CoV2 infection incluant (mais non limité à): fièvre, signes d’infection respiratoire haute, signes digestifs, myalgies, anosmie, dysgeusie, …
    3) Consentement informé à participer à l’essai
    4) Patients en capacité et d’accord pour suivre les procédures de l’étude visites, prélèvements, traitement, etc.)
    E.4Principal exclusion criteria
    1) Initial need for hospitalization for COVID-19 management : defined as any of the following severity criteria : respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly (recommendations HCSP) all other reasons requiring immediate hospitalization left at the discretion of the physician
    2) Pregnancy and breastfeeding
    3) Participation to another interventional drug trial
    4) Subject protected by law under guardianship or curatorship
    5) Absence of health insurance
    6) Known hypersensitivity to camostat mesylate
    7) Known person sharing the same household already included in the study
    1) Nécessité initiale d’hospitalisation pour COVID 19: selon les critères de sévérité suivants: fréquence respiratoire rate > 24 /min au repos, Sp02 < 95% en air ambiant, pression artérielle systolique < 100 mmHg, léthargie ou trouble de la conscience, détérioration globale et brutale ou léthargie pour les sujets âgés (recommandations HCSP) ; tout autre raison à la discrétion du médecin
    2) Grossesse, allaitement
    3) Participation à un autre essai médicamenteux
    4) Patient sous tutelle ou curatelle
    5) Patient non affilié à un régime de Sécurité Sociale
    6) Allergie connue au camostat mesylate
    7) Patient partageant son foyer avec une personne déjà inclus et participant à l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients hospitalized between day 1 and day 21, for COVID-19 deterioration.
    Criteria for hospitalization will be the presence of any of the following: respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly [HCSP] and any all other reasons requiring hospitalization left at the discretion of the physician
    Proportion de patients hospitalisés entre l’inclusion et J21, pour aggravation de la maladie COVID-19
    Criteria for hospitalization will be the presence of any of the following: respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly [HCSP] and any all other reasons requiring hospitalization left at the discretion of the physician
    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 No
    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 Yes
    E.8.1.4Double blind No
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned 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 No
    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
    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.1.3Elderly (>=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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state596
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 596
    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
    NON
    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 Decision2020-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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