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    The EU Clinical Trials Register currently displays   42752   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-003475-18
    Sponsor's Protocol Code Number:COV-AAT
    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:2020-09-16
    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 number2020-003475-18
    A.3Full title of the trial
    The potential of oral Camostat in early COVID-19 disease in an ambulatory setting to reduce viral load and disease burden.
    Het vermogen van Camostat om de virale lading en het ziekteverloop te beïnvloeden wanneer het wordt toegediend in vroege COVID-19 infectie in een ambulante setting.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the antiviral effects of Camostat in COVID-19.
    Studie naar de antivirale effecten van Camostat in COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    COV-AAT
    A.4.1Sponsor's protocol code numberCOV-AAT
    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 SponsorGhent University Hospital
    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 supportOno Pharmaceutical Co., Ltd.
    B.4.2CountryJapan
    B.4.1Name of organisation providing supportByteflies
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportGhent University Hospital
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGhent University Hospital
    B.5.2Functional name of contact pointHIRUZ
    B.5.3 Address:
    B.5.3.1Street AddressC. Heymanslaan 10
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3293320500
    B.5.5Fax number+3293320520
    B.5.6E-mailhiruz.ctu@uzgent.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 Foipan
    D.2.1.1.2Name of the Marketing Authorisation holderOno Pharmaceutical Co., Ltd.
    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 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
    severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    coronavirus disease 2019 (COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    The aim of the study is to assess whether Camostat, a serine protease inhibitor available in an oral formulation, has the potential to be studied as an antiviral drug in a large scale ambulatory setting to prevent transmission by decreasing viral load, to prevent symptoms after exposure (PEP) in asymptomatic individuals or to prevent disease progression in the occurrence of early symptomatology. In this pilot we will assess efficacy of the drug in terms of viral load changes at D5 compared to baseline in nasopharyngeal (or nose/throat) swabs. Cycle threshold values will be used as a surrogate for viral load.

    Descriptive objectives are to assess the safety and compliance of the drug in ambulatory setting.
    E.2.2Secondary objectives of the trial
    - To estimate the clinical outcome of patients based on daily clinical scales;
    - To estimate the effectiveness of the drug to prevent hospitalization, intensive care hospitalization, oxygenation and death at D14 and D28.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudies:
    - PK/PD substudy: pharmacokinetics and pharmacodynamics study on blood;
    - Odor substudy: odor samples study;
    - COVIM2.0 substudy: blood and nasopharyngeal swabs study;
    - Screening failures substudy: blood and nasopharyngeal swabs study.

    Objectives substudies:
    - PK/PD substudy: quantify PK/PD parameters of camostat metabolite and interpatient variability in COVID-19 infected patients;
    - Odor substudy: to estimate whether dogs can be trained to successfully detect COVID-19 positive individuals based on odor;
    - COVIM2.0 substudy: understanding of the pathophysiological mechanisms behind SARS-CoV2;
    - Screening failures substudy: to estimate whether asymptomatic COVID-19 positive individuals with high CT values, not eligible for the drug administration, can transmit the virus and therefore should be isolated and whether they develop antibodies despite their mild infection.
    E.3Principal inclusion criteria
    - Aged ≥18
    - Willing to participate and fill out a daily symptom diary
    - Willing to take the parameters such as blood oxygenation and temperature
    - Willing to attend follow-up visits both by phone as at the clinic
    - Capable of understanding the commitment in the trial
    - Signed informed consent
    - Signs and symptoms suggestive of COVID disease in absence of hospitalization criteria as defined by the flowchart used at the emergency department at Ghent University Hospital, present for maximum 5 days and confirmed by PCR
    • OR documented COVID-19 infection by PCR with CT value below the threshold of 30 in asymptomatic individuals
    - For women of childbearing potential: they should be willing to use highly effective method of contraception during treatment and until the end of study defined as having a failure rate of less than 1% per year when used consistently and correctly
    - For men of reproductive potential: condom should be used as contraception during treatment and until the end of study when having a partner of childbearing potential
    E.4Principal exclusion criteria
    - Inability to make a decision to participate
    - Pregnant or breast feeding
    - Inability to take oral medication
    - Inability to provide informed written consent
    - Known hypersensitivity towards Camostat or other Serine protease inhibitors
    - Any condition that, in the Investigator’s opinion, prevents adequate compliance with study therapy.
    - Any COVID infection at risk for hospitalisation as described in the flow chart used at the emergency department
    - With regard to exclusion of women of child-bearing potential, women who tell us they know they are pregnant are excluded. All women of child-bearing potential who test positive for pregnancy by urine test or serum (if an early pregnancy cannot be excluded) at first visit are excluded
    - Severe chronic pancreatitis requiring suction of gastric juice, fasting or abstention from drinking
    - Postoperative reflux oesophagitis due to reflux or gastric juice
    - Postoperative reflux oesophagitis (if improvement of symptoms is not observed)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to assess the efficacy of the drug in terms of change from day 0 to day 5 in respiratory (oropharyngeal swab RT-PCR) log10 viral load.

    Descriptive endpoints are to assess the safety and compliance of the drug in ambulatory setting.
    E.5.1.1Timepoint(s) of evaluation of this end point
    D5
    E.5.2Secondary end point(s)
    - Days to clinical improvement from study enrolment, defined as no fever for at least 48 hrs AND improvement in other symptoms (e.g. cough, expectoration, myalgia, fatigue, or head ache) using a standardised symptom assessment scale modified from the FLU-PRO tool by DR. Vinetz, Yale University. Symptoms will be assessed daily from D1-D14 and up to D28 if patients are still symptomatic at D14 and compared to baseline using questionnaires and monitoring of temperature 4x daily, oxygen saturation, respiratory rate and heart rate
    - Clinical status as assessed by the 7-point ordinal scale at day 0, 3, 5, 10 and 28 (Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on noninvasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death)
    - The effectiveness of the selected drug to prevent death at D14 and D28
    - The effectiveness of the selected drug to prevent hospitalization and oxygenation at D14 and D28
    - The effectiveness of the selected drug to prevent intensive care hospitalization at D14 and D28
    - If available, the effect of the selected drug on pulmonary infiltrates by RX or HRCT will be assessed at D5 or D10 compared to baseline. The CO-RADS classification will be used to assess the findings
    - If available, the effect of the selected drug on inflammatory parameters at D5 and D10 compared to baseline
    - The efficacy of the drug in terms of change from day 0 to day 10 in respiratory (oropharyngeal swab RT-PCR) log10 viral load in patients with positive PCR at D5
    - The efficacy of the drug in terms of change from day 0 to day 28 in respiratory (oropharyngeal swab RT-PCR) log10 viral load in patients with positive PCR at D10
    - The probability of finding viable virus after virus culture from swabs in COVID 19 infected individuals at D0 (and at D5, D10 and D28 if PCR remains positive)
    - The emergence of resistance for each of the selected drug regimens in case of prolonged viral shedding at D10 and D28 in individuals with positive PCR at these timepoints
    - The presence of neutralising antibodies at D28
    - Number of participant-reported secondary infection of housemates (and/or close contacts) at D28
    E.5.2.1Timepoint(s) of evaluation of this end point
    see secondary end points
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state150
    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 Decision2020-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-24
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