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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2020-002038-33
    Sponsor's Protocol Code Number:LIBERTY
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-06-26
    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 ConcernedFinland - Fimea
    A.2EudraCT number2020-002038-33
    A.3Full title of the trial
    Controlled clinical trial of hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting
    Perusterveydenhuollossa suoritettava kontrolloitu tutkimus hydroksiklorokiinin käytöstä aikuisten Covid-19-potilaiden hoidossa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting
    Perusterveydenhuollossa suoritettava tutkimus hydroksiklorokiinin käytöstä aikuisten Covid-19-potilaiden hoidossa
    A.4.1Sponsor's protocol code numberLIBERTY
    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 SponsorPorin kaupunki
    B.1.3.4CountryFinland
    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 supportPorin kaupunki
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Services Turku - CRST Oy
    B.5.2Functional name of contact pointCRST Oy
    B.5.3 Address:
    B.5.3.1Street AddressItäinen Pitkäkatu 4B
    B.5.3.2Town/ cityTurku
    B.5.3.3Post codeFI-20520
    B.5.3.4CountryFinland
    B.5.6E-mailregulatory@crst.fi
    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 Oxiklorin 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 Capsule, soft
    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 INNHYDROXYCHLOROQUINE SULFATE
    D.3.9.1CAS number 747-36-4
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    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 placeboCapsule, soft
    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 infection
    Covid-19-infektio
    E.1.1.1Medical condition in easily understood language
    Covid-19 infection
    Covid-19-infektio
    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 primary objective of this study is to evaluate the therapeutic potential of HCQ, dosed at 300 mg b.i.d. on the first day and then 200 mg b.i.d. for six days (total dose, 3000 mg), in the treatment of adult patients with PCR-confirmed Covid-19 infection in a primary open-care setting, as compared to placebo.
    E.2.2Secondary objectives of the trial
    Secondary
    to evaluate the safety and tolerability of HCQ in the treatment Covid-19 infection in a primary care setting, as compared to placebo
    to collect experience of the use of HCQ in the treatment of Covid-19 infection in outpatients
    to evaluate the impact of Covid-19 infection and its treatment on the mental health and well-being of the study participants

    Exploratory
    to evaluate the extent and duration of SARS-CoV-2 viral shedding in subjects treated with HCQ compared to placebo
    to evaluate the extent and time course of SARS-CoV-2 virus-specific antibody responses in serum of subjects treated with HCQ compared to placebo
    to evaluate the other possible biomarker changes in blood in subjects treated with HCQ compared to placebo
    to explore the possible effects of genetic variation in drug metabolizing enzymes on HCQ-related outcomes
    to explore the associations of HCQ-related outcome variables with other patient characteristics, e.g. HCQ concentrations and HLA haplotypes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects over 40 years of age, or 18-40 years of age with one or both of the following:
    a. diabetes mellitus (type 1 or type 2)
    b. BMI > 35 kg/m2.
    2. Subjects capable of providing independent informed consent and signing the informed consent form (the subjects’ capacity to consent should be determined in accordance with applicable professional standards and will be based on the investigator's judgment).
    3. Subjects with symptoms typical of Covid-19 infection, according to criteria specified in the study protocol, with or without known or suspected exposure to the SARS-CoV-2 virus. The onset of symptoms must be within 5 days of enrolment. Study medication may only be started once a positive SARS-CoV-2 PCR test results of a nasopharyngeal swab sample is available; if the first PCR test result is negative, a second sample may be collected and analyzed.
    4. Female subjects of child-bearing potential must agree to employ a reliable method of contraception until three months after start of IMP intake.
    5. Subject must agree not to share medication with the others.
    E.4Principal exclusion criteria
    1. Subjects with suspected severe or moderately severe pneumonia, presenting with any of the following: respiratory rate > 26 breaths/min; significant respiratory distress; or SpO2 ≤94 % on room air;
    2. Subjects requiring treatment in the hospital, according to the treating physician’s judgement;
    3. Subjects having any contraindication to treatment with HCQ, such as a long QTc interval (>450 ms in men, >470 ms in women), porphyria, epilepsy, severe renal insufficiency;
    4. Screening 12-lead ECG results showing evidence of clinically significant disturbances of cardiac rhythm or impulse conduction. Atrial fibrillation, paroxysmal supraventricular tachycardia or supraventricular extrasystoles are not exclusionary;
    5. Cardiac insufficiency of NYHA Class 3-4;
    6. History of stroke, within 6 months of screening;
    7. Subjects with a history of seizures within one year of screening;
    8. Subjects with a history of drowning accident;
    9. Any psychiatric diagnosis or symptoms (e.g., hallucinations, major depression, delusions, schizophrenia, bipolar disorder) that, in the opinion of the investigator, could interfere with study procedures or assessments or subject safety;
    10. Disorder related to alcohol or drug abuse, as defined in DSM-5-TR, within one year prior to screening;
    11. Evidence of current or history of any significant autoimmune disease that, in the opinion of the investigator, could interfere with evaluation of the study results or constitute a health hazard for the subject;
    12. Evidence of an immune system that is compromised; including, but not limited to, a diagnosis of HIV; or the subject has been splenectomised or has received an organ transplant (corneal transplants excluded), or is receiving chronic systemic immunosuppressive medication;
    13. Evidence of current clinically significant and possibly unstable pulmonary, gastrointestinal, renal, hepatic, endocrine, haematological or cardiovascular system disease or metabolic disturbance;
    14. Diagnosis of cancer (haematological or solid tumour) for which the subject is currently being treated, or for which there is evidence of active disease. Subjects with local prostate cancer or local dermatological tumours, such as basal or squamous cell carcinoma, may be included;
    15. Any clinically significant abnormalities in laboratory tests, vital signs, ECG or physical examination findings at screening that in the opinion of the investigator require further investigation or treatment or may interfere with study procedures or safety. These may include, but are not limited to, the following:
    a. estimated glomerular filtration ratio (eGFR) < 30 ml/min/1.73 m2, based on the CKD-EPI equation;
    b. a plasma total bilirubin value >2 times the upper limit of the reference range;
    c. plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >3 times the upper limit of the reference range;
    16. Current or anticipated use or recent prior use (pre-study time limits specified in Section 5.4 of the protocol) of disallowed concomitant treatment; use of concomitant medications that prolong the QTc interval is not allowed (see Appendix 1);
    17. Having received in another clinical trial any other investigational medication (unless it can be documented that the subject received only placebo) within 3 months or 5 half-lives (whichever is longer) before screening;
    18. Disease or medication that, in the opinion of the investigator, could seriously impact the assessments of safety, tolerability or efficacy.
    19. Pregnancy or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is number of hospitalizations due to Covid-19 infection within four weeks of entry into the study; the study hypothesis is that treatment with HCQ will reduce the risk of hospitalization because of Covid-19 infection, and the sample size estimate of the study is based on the need to test this hypothesis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be determined by evaluating the patient records, including information collected from health-related registers (the Care Register for Health Care and death certificates archived by Statistics Finland), throughout the treatment period (4 weeks after the first IMP administration)
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are:
    - duration and severity of Covid-19-related symptoms, as reported by the participants in the form of daily self-assessments;
    - number of Intensive Care Unit treatment episodes due to Covid-19 infection within four weeks of entry into the study;
    - number of deaths due to Covid-19 infection within four weeks of entry into the study;
    - number of hospitalizations due to Covid-19 infection within three months of entry into the study;
    - number of Intensive Care Unit treatment episodes due to Covid-19 infection within three months of entry into the study;
    - number of deaths due to Covid-19 infection within three months of entry into the study;
    - number of treatment-related adverse events (AEs) and serious AEs (SAEs);
    - number of participants with treatment-related AEs and SAEs;
    - all-cause mortality within six months of entry into the study (including post-study follow-up of consenting participants);
    - all-cause hospitalizations within six months of entry into the study (including post-study follow-up of consenting participants); and
    - self-assessed symptoms of anxiety of the study participants, as assessed with repeated administration of the Generalized Anxiety Disorder 7-item Scale (GAD-7).

    The exploratory endpoints of the study include the following:
    - extent and duration of SARS-CoV-2 viral shedding, as evaluated with PCR testing of nasopharyngeal swab samples;
    - extent and time course of SARS-CoV-2 virus-specific antibody responses in serum;
    - possible other biomarker changes in blood in study subjects.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the first two weeks of the treatment period, the subjects are asked to report their symptoms (including body temperature and SpO2) ) in the form of daily self-assessments and daily telephone contacts. At the 2-week and 4-week visits, the subjects will complete GAD-7 questionnaire and undergo the laboratory (the safety, antibody, biomarker, SARS-CoV-2 PCR and HCQ concentration) assessments. Vital signs (body temperature and SpO2) are measured at the 2-week visit. AEs will be collected from informed consent until the end of the follow-up period. The patient records will be evaluated, including information collected from health-related registers (the Care Register for Health Care and death certificates archived by Statistics Finland), until 6 months after start of IMP intake.
    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 Yes
    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 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 concerned7
    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
    The trial will end when register-based follow-up of the last enrolled participant will end.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state600
    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 Decision2020-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-30
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