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    The EU Clinical Trials Register currently displays   38528   clinical trials with a EudraCT protocol, of which   6333   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001558-23
    Sponsor's Protocol Code Number:COFID19-AIFA17/2020
    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:2020-06-26
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001558-23
    A.3Full title of the trial
    Hydroxychloroquine sulfate early administration in symptomatic out of hospital COVID-19 positive patients. Hydro-Stop-COVID19 Trial
    Utilizzo precoce a domicilio di Idrossiclorochina solfato in pazienti affetti da COVID 19. Hydro-STOP-COVID19 Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hydroxychloroquine sulfate early administration in symptomatic out of hospital COVID-19 positive patients. Hydro-Stop-COVID19 Trial
    Utilizzo precoce a domicilio di Idrossiclorochina solfato in pazienti affetti da COVID 19. Hydro-STOP-COVID19 Trial
    A.3.2Name or abbreviated title of the trial where available
    Hydro-STOP-COVID19 Trial
    Hydro-STOP-COVID19 Trial
    A.4.1Sponsor's protocol code numberCOFID19-AIFA17/2020
    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 SponsorASUR (Azienda Sanitaria Unica Regionale) Marche
    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 organisationASUR MARCHE
    B.5.2Functional name of contact pointUOC Cardiologia ASUR AV5
    B.5.3 Address:
    B.5.3.1Street AddressViale Iris 1
    B.5.3.2Town/ cityAscoli piceno
    B.5.3.3Post code63100
    B.5.3.4CountryItaly
    B.5.6E-mailhcq.stop.covid19.trial@gmail.com
    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 Plaquenil
    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 namePLAQUENIL
    D.3.2Product code [P01BA02]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor code1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number800
    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
    Emerging disease (COVID-19) due to a novel coronavirus (named SARS-CoV-2 latter) started in Wuhan, China and rapidly spread in China and outside and has been declared pandemic by WHO on March 12th 2020. It has been shown that an excessive immune response to the SARS-CoV-2 virus would results in hyper-inflammation, with excessive increase of cytokines IL6 and IL10. This may progress to a cytokine storm, followed by multiorgan failure and potentially death.
    L’esperienza in corso indica che COVID19 si caratterizza come una forma di infezione caratterizzata da un esordio con sintomi influenzali per poi evolvere verso una sintomatologia alle vie respiratorie più importante caratterizzata da un quadro di polmonite e via via, in una percentuale sempre più ristretta di persone verso un quadro da insufficienza respiratoria che può evolvere fino alla ARD grave.
    E.1.1.1Medical condition in easily understood language
    COVID-19 due to a novel coronavirus (named SARS-CoV-2 latter) may progress to a cytokine storm, followed by multiorgan failure and potentially death.
    COVID19 è una forma di infezione caratterizzata da un esordio con sintomi influenzali per poi evolvere verso un quadro da insufficienza respiratoria che può evolvere fino alla ARD grave.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10063099
    E.1.2Term Viral syndrome
    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 out-of-hospital treatment with HCQ in the reducing viral loads and need for hospitalization in symptomatic SARS-CoV-2 infected patient who are confined at home.
    Lo studio quindi si propone di dimostrare l’efficacia dell’HCQ nel ridurre la crescita virale e la conseguente sintomatologia nel paziente a domicilio nella fase iniziale della malattia.
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with SARS-CoV-2 infection in a nasopharyngeal sample, with diagnosis, carried out in a centralized core-lab.
    2. Patients confined at home because their clinical picture was judged by the local Health authorities not severe enough to require hospitalization.
    3. Patients agree to maintain seclusion at home up to viral negativization of the nasopharyngeal test in two consecutive samples, according to Italian laws.
    4. Patients with 1 or more of the following symptoms/signs on the day of nasopharyngeal sample: 1) Fever (>37.0° Celsius); 2) Cough.
    1. Pazienti con infezione da SARS-CoV-2 (diagnosi effettuata in un laboratorio centrale centralizzato con modalità definite) > 18 aa ed in isolamento domiciliare obbligato
    2. Che dopo informativa hanno firmato il consenso
    3. in isolamento domiciliare per quadro clinico lieve caratterizzato dalla presenza si 1 o più dei seguenti sintomi / segni nel giorno del campione nasofaringeo positivo:
    • Febbre (> 37,0 ° Celsius);
    • Tosse.
    E.4Principal exclusion criteria
    1. Age <18 years.
    2. Allergy to HCQ or chloroquine.
    3. Contraindication to treatment with the study drug for one or more of the following conditions: retinopathy, G6PD deficiency, Long-QT syndrome or treatment with drugs associated with QTc prolongation (unless these drugs can be safely discontinued during HCQ treatment). Appendix 1 shows a table, derived from AIFA, which lists these drugs.
    4. Breastfeeding and pregnant patients will be excluded based on their declaration and pregnancy test results when required.
    1. Allergia a HCQ o clorochina.
    2. Controindicazione al trattamento con il farmaco in studio per una o più delle seguenti condizioni: retinopatia, deficit di G6PD, sindrome del QT lungo o trattamento con farmaci associati al prolungamento del QTc (a meno che questi farmaci non possano essere interrotti in modo sicuro durante il trattamento con HCQ). (viene fornito elenco)
    3. L'allattamento e gravidanza (definita in base ad auto dichiarazione e ai risultati dei test di gravidanza quando richiesto).
    E.5 End points
    E.5.1Primary end point(s)
    virological clearance (nasopharyngeal sample negative for SARS-CoV-2 virus) at the sample taken on days 8. Co-primary end-point: Hospital admission over the time-interval between day 0 (randomization) and day 15.
    clearance virologica (campione rinofaringeo negativo per il virus SARS-CoV-2) al campione prelevato nei giorni 7-9. (viene fatto anche un2° test al giorno 14-17)
    E.5.1.1Timepoint(s) of evaluation of this end point
    7-15 days
    7-15 gg
    E.5.2Secondary end point(s)
    a) Need for intubation during the interval between day 0 (randomization) and day 15;
    b) All-cause death during the interval between day 0 (randomization) and day 15.
    c) Virological clearance in all samples (both day 8 and day 15)
    d) Composite of a), b), c). The first-occurring component will be considered for analysis.
    1) esito composito: clearance virologica in tutti i campioni + ricovero ospedaliero nel corso di 2 settimane a causa di complicanze dell'infezione virale + intubazione nel corso di 2 settimane + morte nel corso di 2 settimane;
    2) Ciascuno dei singoli componenti dell'endpoint secondario
    E.5.2.1Timepoint(s) of evaluation of this end point
    15-28 days
    15-28 gg
    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) 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 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
    Terapia standar
    Standard therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state216
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 216
    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)
    According to the guideline for COVID19
    Secondo pratica clinica ordinaria per COVID19
    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 Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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