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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41472   clinical trials with a EudraCT protocol, of which   6816   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2020-001469-35
    Sponsor's Protocol Code Number:Wroclaw_Corona_Study_2020
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-08
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-001469-35
    A.3Full title of the trial
    A multicenter, open, randomized, non-commercial study to evaluate the efficacy and safety of chloroquine phosphate in the outpatient treatment of COVID-19 in combination with telemedicine care for patients with SARS-CoV-2 infection with the risk of developing complications to reduce the risk of COVID-19-related hospitalization and death.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter, open, randomized, non-commercial study to evaluate the efficacy and safety of chloroquine phosphate in the outpatient treatment of COVID-19 in combination with telemedicine care for patients with SARS-CoV-2 infection with the risk of developing complications to reduce the risk of COVID-19-related hospitalization and death.
    A.4.1Sponsor's protocol code numberWroclaw_Corona_Study_2020
    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 SponsorWroclaw Medical University
    B.1.3.4CountryPoland
    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 supportWroclaw Medical University
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWroclaw Medical University Prof. Ewa Jankowska
    B.5.2Functional name of contact pointClinical Trial Information Point
    B.5.3 Address:
    B.5.3.1Street AddressWybrze┼╝e L. Pasteura 1
    B.5.3.2Town/ cityWroclaw
    B.5.3.3Post code50-367
    B.5.3.4CountryPoland
    B.5.4Telephone number0048608553169
    B.5.6E-mailewa.jankowska@umed.wroc.pl
    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 Arechin
    D.2.1.1.2Name of the Marketing Authorisation holderAdamed Pharma S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameChlorine phosphate (Arechin)
    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 INNCHLOROQUINE PHOSPHATE
    D.3.9.1CAS number 50-63-5
    D.3.9.3Other descriptive nameCHLOROQUINE PHOSPHATE
    D.3.9.4EV Substance CodeSUB01238MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 (Coronavirus Disease 2019)
    E.1.1.1Medical condition in easily understood language
    The disease syndrome resulting from SARS-CoV-2 infection . (COVID-19 - novel COronaVIrus Disease 2019)
    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 PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    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 aim of the study is to evaluate whether the therapy with chloroquine phosphate (CQ, in combination with telemedical approach) in addition to standard care is effective and safe in reducing composite endpoint of COVID-19-related hospitalization or all cause death in 15-day observation, in ambulatory patients with SARS-SoV-2 infection (in comparison with subjects not treated with CQ but receiving standard care and supervised telemedically).
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The study will include 400 subjects meeting the following inclusion
    criteria:
    1. Age ≥ 60 years
    OR
    Age 18-59 with one of the following conditions:
    - chronic lung disease (defined as: previous diagnosis of chronic
    obstructive pulmonary disease, previous diagnosis of bronchial asthma,
    or previous diagnosis of another lung disease requiring chronic
    inhalation therapy)
    - chronic cardiovascular disease (defined as: previous diagnosis of heart failure, hypertension requiring pharmacotherapy, past myocardial infarction or any coronary revascularization)
    -diabetes requiring pharmacotherapy
    - malignancy diagnosed within 5 years prior to enrollment (excluding haematological neoplasms) after the application of radical treatment
    - history of chronic kidney disease (defined as eGFR according to the MDRD formula <60 ml/min / 1.73m2)
    - atrial fibrillation (any type found in the past or now)
    - haemorrhagic stroke, ischemic stroke or transient cerebral ischemia
    - obesity defined as BMI ≥ 30 kg / m2
    - 10-year risk of fatal CVD in populations at high CVD risk based on the following risk factors: age, gender, smoking status, systolic blood pressure, total cholesterol - SCORE (Systematic COronary Risk Evaluation) ≥ 10%
    2. SARS-CoV-2 infection (positive PR-PCR test for SARS-CoV-2)
    3. Indication for treatment at home isolation or public isolation
    centre
    E.4Principal exclusion criteria
    1. No informed consent to participate in the study
    2. Patient's inability to comply with the protocol in the investigator's evaluation
    3. Administration of chloroquine or hydroxychloroquine in the last 30
    days prior to inclusion in the study
    4. Administration antiviral drugs in the last 14 days prior to inclusion in the study
    5. Contraindications for the use of chloroquine phosphate:
    • Pregnancy or breastfeeding period
    • Kidney failure (eGFR<10mL/min/1.73m^2)
    • Cirrhosis or liver damage (AST or ALT or GGTP activity ≥ 3xULN)
    • Alcoholic disease (any time)
    • History of Hematological diseases
    • History of Porphyria
    • History of Epilepsy diagnosed
    • History of myasthenia
    • History of Retinal diseases
    • Fainting or lapse into unconsciousness in the last year
    • Treatment with amiodarone in the last 3 months before inclusion
    6. Hypersensitivity to the active substance (chloroquine phosphate) or to any of the excipients of Arechin
    7. Infection with Human Immunodeficiency Virus (HIV) on the basis of medical history.
    8. Abnormal laboratory tests results, medical events and any other circumstances (such as insufficient knowledge of Polish), which in the researcher's opinion may be harmful to the subject or prevent the study from being conducted in accordance with the protocol.
    9. Participation in any another clinical trial in the last 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    Hospitalisation due to COVID-19 or death for any cause in 15-day observation (up to and including the 15th study)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15 (the day after the 14-day treatment cycle)
    E.5.2Secondary end point(s)
    Secondary endpoints related to effectiveness:
    1. no symptoms of COVID-19 in 15-day observation:
    o Fever
    o Tachycardia
    o Abnormal saturation
    o Cough
    o Dyspnea at rest
    o Dyspnea in small life activities
    o Chest compressions
    o Chest pain during inhalation/expiration
    o Headache
    o Sinus pain
    o Cold
    o Sore throat
    o General weakness
    o Pain or muscle weakness
    o Appetite deterioration
    o Olfactory deprivation
    o Flavour depreciation
    o Nausea or vomiting
    o Diarrhoea
    o Dizziness

    2. No symptoms of COVID-19 in a 42-day or shorter observation for patients who did not have 42 days at the end of 15-day observation for the last patient on:
    o Fever
    o Tachycardia
    o Abnormal saturation
    o Cough
    o Dyspnea at rest
    o Dyspnea in small life activities
    o Chest compressions
    o Chest pain during inhalation/expiration
    o Headache
    o Sinus pain
    o Cold
    o Sore throat
    o General weakness
    o Pain or muscle weakness
    o Appetite deterioration
    o Olfactory deprivation
    o Flavour depreciation
    o Nausea or vomiting
    o Diarrhoea
    o Dizziness
    3. No hospitalisation due to COVID-19 or death for any cause in a 42-day or shorter observation for patients for whom the 42-day or shorter observation has not passed at the end of the 15-day observation for the last patient included
    4. No death for any cause in a 42-day or shorter observation for patients for whom 42 days have not passed at the end of a 15-day observation for the last patient included

    Secondary safety related endpoints:
    1.Do not discontinue the drug due to side effects in 15-day observation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 1-1
    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 Yes
    E.6.4Safety Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard symptomatic treatment in combination with telemedical care
    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 concerned10
    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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days21
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state400
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-31
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