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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   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:2020-001482-37
    Sponsor's Protocol Code Number:COVID65+
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-20
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2020-001482-37
    A.3Full title of the trial
    Randomized controlled trial of hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of elderly COVID-19 Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized controlled trial of hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of elderly COVID-19 Patients
    A.4.1Sponsor's protocol code numberCOVID65+
    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 SponsorUniversity Hopsital Tuebingen
    B.1.3.4CountryGermany
    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 Hydroxychloroquin-ratiopharm 200 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderRationpharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    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.3.9.1CAS 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 number200
    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 placeboFilm-coated tablet
    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
    Coronavirus disease
    E.1.1.1Medical condition in easily understood language
    Coronavirus diseas
    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
    Rate of hospitalization or death at day 7 after study
    inclusion
    E.2.2Secondary objectives of the trial
    Duration of hospitalization
    ● Time to hospitalization
    ● Reason for hospitalization
    ● severity of disease at hospitalization
     All-cause mortality within 30/60 days
    ● COVID19 related mortality within 30/60 days
    ● Proportion requiring invasive ventilation
    ● Proportion admitted to ICU
    ● Rate of viral clearance defined as SARS-CoV2 specific
    RNA copy number <100 in throat swabs on day 7
    ● Optional rate of viral clearance on d 14, 21
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent
    • Age ≥ 65 years
    • Mild to moderate symptomatic respiratory tract Infection
    • Proven SARS-Cov2 infection by throat swab (PCR)
    • Onset of symptoms within the last 3 days before randomization
    • Must be able to adhere to the study visit schedule and other protocol requirements in the investigator’s opinion.
    E.4Principal exclusion criteria
    • Hospitalization at study inclusion
    • Weight <50 kg
    • Acute myocardial infarction
    • Use of concomitant medications that prolong the QT/QTc interval.
    • QTc >450ms
    • Bilirubin ≥ 1,5 x UNL,
    • AST/ALT ≥ 3 x ULN
    • Albumine ≤ 2.8 g/dl
    • Hemoglobin ≤ 9 g/dl
    • Leucocytes ≤ 2000/µl
    • Neutrophiles ≤ 1000/µl
    • Thrombocytes ≤ 100.000/µl
    • Troponin elevation
    • BNP > 500 pg/ml
    • Creatine kinase > 5 x ULN
    • Creatinine >1,5 mg/dl
    • Uncorrected hypopotassemia or hypomagnesemia
    • History of hypoglycemic events
    • History of or present cardial arrhythmia (except atrial fibrillation or paroxysmal supraventricular tachycardia)
    • History of Retinopathy or Maculopathy
    • Psoriasis
    • Myasthenia gravis
    • Immunodeficiency syndromes or need for highly immunosuppressive medication
    • Pre-existing medication with hydroxychloroquine
    • Known G6PD deficiency.
    • Participation in another interventional study
    • Known hypersensibility to hydroxychloroquine and its derivates
    • Subject (male or female) is not willing to use highly effective methods of contraception according to the “Clinical trial fertility group” recommendations (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) during treatment until day 30 from first dose (adequate: combined hormonal contraceptionassociated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormonereleasing-system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2).
    1 Vasectomized partner is a highly effective birth control method provided that partner is the
    sole sexual partner of the WOCBP trial participant and that the vasectomized partner has
    received medical assessment of the surgical success2 In the context of this guidance sexual
    abstinence is considered a highly effective method only if defined as refraining from
    heterosexual intercourse during the entire period of risk associated with the study treatments.
    The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
    E.5 End points
    E.5.1Primary end point(s)
    Hospitalization or death
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days after first dosis
    E.5.2Secondary end point(s)
    Duration of hospitalization
    ● Time to hospitalization
    ● Reason for hospitalization
    ● severity of disease at hospitalization
     All-cause mortality within 30/60 days
    ● COVID19 related mortality within 30/60 days
    ● Proportion requiring invasive ventilation
    ● Proportion admitted to ICU
    ● Rate of viral clearance defined as SARS-CoV2 specific
    RNA copy number <100 in throat swabs on day 7
    ● Optional rate of viral clearance on d 14, 21
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 days after first dosis
    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 No
    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 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 concerned2
    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
    Follow-up after treatment to day 60
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 No
    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 state350
    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)
    Follow-up after treatment til day 60 from first dosis
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-07
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