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    Summary
    EudraCT Number:2020-001441-39
    Sponsor's Protocol Code Number:VIR20001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-06-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001441-39
    A.3Full title of the trial
    Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)
    Prevenzione della malattia da Coronavirus (COVID-19) in ambito sanitario con clorochina/idrossiclorochina: uno studio di profilassi, randomizzato controllato con placebo (COPCOV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study (COPCOV)
    Prevenzione della malattia da Coronavirus (COVID-19) in ambito sanitario con clorochina/idrossiclorochina: uno studio di profilassi, randomizzato controllato con placebo (COPCOV)
    A.3.2Name or abbreviated title of the trial where available
    COPCOV - Study of COVID-19 and Chloroquine/hydroxychloroquine in healthcare setting
    COPCOV - Studio su COVID-19 e clorochina / idrossiclorochina in ambito sanitario
    A.4.1Sponsor's protocol code numberVIR20001
    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 OF OXFORD
    B.1.3.4CountryUnited Kingdom
    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 supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRCCS Sacro Cuore Don Calabria
    B.5.2Functional name of contact pointUnità per la Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Don A. Sempreboni, 5
    B.5.3.2Town/ cityNegrar di Valpolicella
    B.5.3.3Post code37024
    B.5.3.4CountryItaly
    B.5.4Telephone number0456014854
    B.5.6E-mailricerca.clinica@sacrocuore.it
    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 No
    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 nameIdrossiclorochina
    D.3.2Product code [n.d.]
    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.3.9.1CAS number 118-42-3
    D.3.9.2Current sponsor coden.d.
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Profliaxis of SARS-CoV-2 infection
    Profilassi dell’infezione da SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    Prevention of the infection from Coronavirus
    Prevenzione dell'infezione da Coronavirus
    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 LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if chloroquine or hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in health care workers or other groups at high risk.
    To determine if chloroquine or hydroxychloroquine prophylaxis attenuates COVID-19 infections.
    • Determinare se la profilassi con clorochina o idrossiclorochina previene l'infezione sintomatica da SARS-CoV-2 negli operatori sanitari o in altri gruppi ad alto rischio.
    • Determinare se la profilassi con clorochina o idrossiclorochina attenua le infezioni da SARS-CoV-2.
    E.2.2Secondary objectives of the trial
    To determine if chloroquine or hydroxychloroquine prophylaxis prevents asymptomatic COVID-19 infection.
    To determine if chloroquine or hydroxychloroquine prophylaxis prevents all-cause symptomatic acute respiratory illnesses.
    To characterise genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity.
    • Determinare se la profilassi con clorochina o idrossiclorochina previene l'infezione asintomatica da SARS-CoV-2.
    • Determinare se la profilassi con clorochina o idrossiclorochina previene le malattie respiratorie acute sintomatiche per tutte le cause.
    • Caratterizzare marcatori genetici e biochimici basali associati a COVID-19 sintomatico, malattia respiratoria e gravità della malattia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct
    • Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals
    • Adults (exact age is dependent on countries)
    • Not previously diagnosed with COVID-19
    • Not currently symptomatic with an ARI
    • Participant A. works in healthcare facility or other well characterised high-risk environment, OR B. is an inpatient or relative of a patient in a participating hospital and likely exposed to COVID-19 infection or another high-risk group
    • Possesses an internet-enabled smartphone (Android or iOS)
    • Soggetti adulti che lavorano in una struttura sanitaria, senza precedente diagnosi di COVID-19, che accettano di non auto-medicarsi con clorochina, idrossiclorochina o altri potenziali antivirali
    • Consenso informato alla partecipazione allo studio
    • Attualmente non sintomatici per ARI
    • In possesso di uno smartphone abilitato a Internet (Android o iOS)
    E.4Principal exclusion criteria
    • Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines
    • Contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance < 10 ml/min
    • Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines
    • Taking a concomitant medication described in section 8.5, which cannot be safely stopped
    • Known retinal disease
    • Inability to be followed up for the trial period
    • Known prolonged QT syndrome (however ECG is not required at baseline)
    • Ipersensibilità a clorochina, idrossiclorochina o 4-amminochinoline
    • Controindicazione all'assunzione di clorochina come profilassi, ad es. epilettico noto, clearance della creatinina nota <10 ml / min
    • Assunzione in corso di clorochina, idrossiclorochina o 4-amminochinoline
    • Assunzione di un farmaco concomitante non ammesso (vd. sezione 8.5 del protocollo), che non può essere interrotto in modo sicuro
    • Malattia retinica nota
    • Impossibilità ad essere seguiti per la durata dello studio
    • Sindrome nota del QT lungo (tuttavia non è richiesto l'ECG al basale)
    E.5 End points
    E.5.1Primary end point(s)
    The number of symptomatic COVID-19 infections will be compared between the chloroquine and placebo groups.
    The symptoms severity and duration of COVID-19 illness, in those who become infected during the study will be compared between the two groups using a respiratory severity score.
    • Numero di infezioni COVID-19 sintomatiche nei gruppi clorochina/idrossiclorochina e placebo.
    • Sintomi, gravità e durata di COVID-19, in coloro che vengono infettati durante lo studio, nei due gruppi, usando un punteggio di gravità.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the clinical trial
    Durante lo svolgimento dello studio
    E.5.2Secondary end point(s)
    The number of asymptomatic cases of COVID-19 will be determined by comparing acute and convalescent serology in the two groups.; The number and severity of symptomatic acute respiratory illnesses will be compared in subjects randomised to chloroquine or placebo.; Genetic loci and levels of biochemical components will be correlated with occurrence of and disease severity of COVID-19 or other ARIs.
    • Numero di casi COVID-19 asintomatici determinato mediante la sierologia acuta e convalescente nei due gruppi.; • Numero e gravità delle malattie respiratorie acute sintomatiche nei due gruppi; • I loci genetici e i livelli dei markers biochimici saranno correlati con la frequenza di COVID-19, ARI e gravità della malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During clinical trial; During clinical trial; During clinical trial
    Durante lo svolgimento dello studio; Durante lo svolgimento dello studio; Durante lo svolgimento dello studio
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Indonesia
    Kenya
    Lao People's Democratic Republic
    Malawi
    Thailand
    Uganda
    Vietnam
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 37500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2500
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-06-24. Yes
    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.4.2.1In the EEA 15000
    F.4.2.2In the whole clinical trial 40000
    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)
    Not applicable
    Non applicabile
    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 Decision2020-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    The status of studies in GB is no longer updated from 1.1.2021
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