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    The EU Clinical Trials Register currently displays   38526   clinical trials with a EudraCT protocol, of which   6331   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001987-28
    Sponsor's Protocol Code Number:PRECOV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    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 number2020-001987-28
    A.3Full title of the trial
    PRECOV: a randomized controlled clinical trial on the effects of hydroxychloroquine in the prevention of COVID-19 in healthcare workers at risk
    PRECOV: studio clinico controllato e randomizzato sugli effetti della idrossiclorochina nella prevenzione di COVID-19 in operatori sanitari a rischio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PRECOV: a randomized controlled clinical trial on the effects of hydroxychloroquine in the prevention of COVID-19 in healthcare workers at risk
    PRECOV: studio clinico controllato e randomizzato sugli effetti della idrossiclorochina nella prevenzione di COVID-19 in operatori sanitari a rischio
    A.3.2Name or abbreviated title of the trial where available
    PRECOV
    PRECOV
    A.4.1Sponsor's protocol code numberPRECOV
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    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 organisationIRCCS Ospedale San Raffaele
    B.5.2Functional name of contact pointIRCCS Ospedale San Raffaele
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number+390226432990
    B.5.5Fax number+390226433746
    B.5.6E-mailcomi.giancarlo@hsr.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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 SOLFATO
    D.3.2Product code [IDROSSICLOROCHINA SOLFATO]
    D.3.4Pharmaceutical form Coated 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 INNIDROSSICLOROCHINA SOLFATO
    D.3.9.1CAS number 118-42-3
    D.3.9.2Current sponsor codeIDROSSICLOROCHINA SOLFATO
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthcare personnel at risk of SARS-CoV-2 infection
    Personale sanitario a rischio d'infezione da SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    Healthcare personnel at risk of SARS-CoV-2 infection
    Personale sanitario a rischio d'infezione da SARS-CoV-2
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10061986
    E.1.2Term SARS
    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 evaluate the efficacy of the preventive treatment with hydroxychloroquine in reducing the risk of SARS-CoV-2 infection in healthcare workers at risk
    Valutare l’efficacia del trattamento preventivo con idrossiclorochina nel ridurre il rischio di infezione da SARS-CoV-2 in personale sanitario a rischio.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of the preventive treatment with hydroxychloroquine in reducing the severity of COVID-19 clinical manifestations
    • To evaluate the safety and tolerability of hydroxychloroquine as a prophylaxis treatment for SARS-CoV-2
    • Valutare l’efficacia del trattamento preventivo con idrossiclorochina nel ridurre la gravità di manifestazioni cliniche di COVID-19
    • Valutare la sicurezza e la tollerabilità del trattamento di profilassi per SARS-CoV-2 con idrossiclorochina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent for participation to the study
    2. Age between 18 and 70 years
    3. RT-PCR negative for SARS-CoV-2
    4. Antibody test for negative SARS-CoV-2
    1. Consenso informato per la partecipazione allo studio
    2. Età compresa tra i 18 ed i 70 anni
    3. RT-PCR negativo per SARS-CoV-2
    4. Test anticorpale per SARS-CoV-2 negativo
    E.4Principal exclusion criteria
    1. Presence of co-morbidity or concomitant intake of drugs that can interfere with the risk of contracting the infection or influence its course: diabetes, heart failure, neoplastic pathologies, etc.)
    2. Immunoactive treatments ongoing
    3.State of pregnancy or breastfeeding
    4. Contraindications to the use of hydroxychloroquine:
    History of hypersensitivity or allergy to hydroxychloroquine
    b.Deficit of glucose-6 phosphate dehydrogenase
    c.Porfiria
    d.Psoriasi
    e.Weight <40 kg
    f) Previously referred to as retinopathy or visual field disturbances or concomitant intake of drugs known to induce retinopathy (e.g. tamoxifen)
    g. Previous ventricular cardiac dysrhythmias or proarrhythmic conditions (e.g. bpm <50 / min)
    h. Concomitant use of digoxin or drugs known to prolong the QT interval (class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics, halofantrine), insulin or oral hypoglycaemic agents, phenylbutazone, cyclosporine, mefloquine or other antimalarial drugs, anti-septal drugs
    I. severe chronic renal failure (creatinine clearance <10 ml / min)
    5. Hydroxychloroquine treatment at any dose, and for any duration and motivation in the last 6 months
    6. Previous diagnosis of COVID-19 or previous symptoms suggestive of disease
    1.Presenza di co-morbilità o assunzione concomitante di farmaci che possono interferire col rischio di contrarre l’infezione o influenzarne il decorso: diabete, insufficienza cardiaca, patologie neoplastiche, ecc)
    2.Trattamenti immunoattivi in corso
    3.Stato di gravidanza e allattamento
    4.Controindicazioni all’utilizzo di idrossiclorochina:
    a.Storia di ipersensibilità o allergia ad idrossiclorochina
    b.Deficit di glocosio-6 fosfato deidrogenasi
    c.Porfiria
    d.Psoriasi
    e.Peso < 40 kg
    f.Pregressa riferita retinopatia o disturbi del campo visivo o concomitante assunzione di farmaci noti per indurre retinopatia (es tamoxifene)
    g.Pregresse disritmie cardiache ventricolari o condizioni proaritmiche (es bpm< 50/min)
    h.Utilizzo concomitante di digossina o di farmaci noti per prolungare l’intervallo QT (antiaritmici di classe IA e III, antidepressivi triciclici, antipsicotici, alofantrina), insulina o ipoglicemizzanti orali, fenilbutazone, ciclosporina, meflochina o altri antimalarici, farmaci antiepilettici
    i.Insufficienza renale cronica di grado severo (clearance della creatinina < 10 ml/min)
    5.Assunzione di idrossiclorochina per qualsiasi dose, durata e motivazione negli ultimi 6 mesi
    6.Pregressa diagnosi di COVID-19 o pregressi sintomi suggestivi di malattia
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of hydroxychloroquine treated subjects treated with SARS-CoV-2 positive nasopharyngeal swab compared to controls
    • Proporzione dei soggetti trattati con idrossiclorochina con tampone nasofaringeo positivo per SARS-CoV-2 rispetto ai controlli
    E.5.1.1Timepoint(s) of evaluation of this end point
    At days +14 and +28 from the start of the treatment
    Nei giorni +14 e +28 dall’inizio del trattamento
    E.5.2Secondary end point(s)
    • Proportion of hydroxychloroquine treated subjects admitted to an intensive care unit for COVID-19, compared to controls; • Proportion of hydroxychloroquine treated subjects interstitial pneumonia typical of COVID-19, compared to controls; • Proportion of adverse and severe adverse events in hydroxychloroquine treated subjects compared to controls; • Proportion of hydroxychloroquine treated subjects with two or more typical COVID-19 clinical manifestations (dry cough, dyspnoea, fever, pharyngodynia, myalgias, dysgeusia or anosmia, conjunctivitis, nausea, vomiting or diarrhea), compared to controls; • Proportion of hydroxychloroquine treated subjects with SARS-CoV-2 specific antibodies, compared to controls; • Proportion of hydroxychloroquine treated subjects hospitalized for COVID-19, compared to controls
    • Proporzione dei soggetti trattati con idrossiclorochina che accedono alle cure intensive per COVID-19 rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina con polmonite interstiziale da SARS-CoV-2 rispetto ai controlli; • Proporzione dei soggetti in trattamento di profilassi con idrossiclorochina che presentano eventi avversi ed eventi avversi gravi rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina con due o più manifestazioni cliniche tipiche di COVID-19 (tosse secca, dispnea, febbre, faringodinia, mialgie, disgeusia o anosmia, congiuntivite, nausea vomito o diarrea) rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina con positività degli anticorpi anti SARS-CoV-2 rispetto ai controlli; • Proporzione dei soggetti trattati con idrossiclorochina ospedalizzati per COVID-19 rispetto ai controlli
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine; At day 28 + 14 from the start of treatment with hydroxychloroquine; At day +14, +28 and +42 from the start of the treatment with hydroxychloroquine
    Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina; Giorno 28 + 14 dall’inizio del trattamento con idrossiclorochina; Al giorno +14, +28 e +42 dall’inizio del trattamento con idrossiclorochina
    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 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) 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 Yes
    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
    Solo Dispositivi di Protezione Individuale
    Personal Protective Equipment only
    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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    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: 950
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 1000
    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)
    Normal clinical practice
    Normale pratica clinica
    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 Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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