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    Summary
    EudraCT Number:2020-002283-32
    Sponsor's Protocol Code Number:2020-34
    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:2020-08-10
    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 number2020-002283-32
    A.3Full title of the trial
    Randomized, Double-blind, Multi Centre Phase II, Proof of Concept, Dose Finding Clinical Trial on Ivermectin for the early Treatment of COVID-19
    Studio clinico randomizzato, in doppio cieco, multicentrico, di fase II, Proof of Concept, Dose Finding sull'impiego dell'Ivermectina per il trattamento precoce del COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Double-blind, Multi Centre Phase II, Dose Finding Clinical Trial on Ivermectin for the early Treatment of COVID-19
    Studio clinico randomizzato, in doppio cieco, multicentrico, di fase II, per l'individuazione del dosaggio di impiego dell'Ivermectina per il trattamento precoce del COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COVER
    COVER
    A.4.1Sponsor's protocol code number2020-34
    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 CLASSIFICATO EQUIPARATO SACRO CUORE DON CALABRIA - PRESIDIO OSPEDALIERO ACCREDITATO
    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 supportLaboratorios Liconsa (Chemo Group)
    B.4.2CountrySpain
    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 (VR)
    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 nameIvermectina
    D.3.2Product code [-]
    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 70288-86-7
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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.IMP: 2
    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 nameIvermectina
    D.3.2Product code [-]
    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 70288-86-7
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    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
    The study is aimed:
    1) at defining if ivermectin, administered at dosage of 600 µg/kg or 1200 µg/kg QD for five consecutive days is safe in patients with initial, asymptomatic or oligosymptomatic SARS_CoV-2 infection,
    2) at defining if ivermectin, administered at the dosage(s) found to be safe decreases the viral load of SARS-CoV-2 at Day 7.
    Lo studio è inteso a:
    1. definire se l'ivermectina, somministrata alla dose di 600 mcg/kg o 1200 mcg/kg QD per cinque giorni consecutivi è sicura nei pazienti con infezione SARS_CoV2 iniziale, asintomatica o paucisintomatica e:
    2. definire se l'ivermectina, somministrata al dosaggio (i) trovato (i) sicuro, riduce la carica virale di SARS-CoV2 al 7 ° giorno.
    E.2.2Secondary objectives of the trial
    Secondary objectives
    To assess
    1. the temporal profile of viral load at baseline, day 7, 14 and 30
    2. the time to clinical cure (for symptomatic patients)
    3. the proportion of patients with virological clearance at day 14 and 30.
    4. the hospitalization rate.
    5. the COVID-19 Severity Score at day 14 and 30
    Valutare
    1. il profilo temporale della carica virale al basale e ai giorni 7, 14 e 30
    2. il tempo di remissione clinica (per i pazienti sintomatici)
    3. la percentuale di pazienti con clearance virologica al giorno 14 e 30
    4. il tasso di ospedalizzazione
    5. il COVID-19 Severity Score ai giorni 14 e 30
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacokynetics study - Vers. 1.0 - 01.05.2020 - Objective: to evaluate the association between plasma drug concentration and clinical endpoints

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Studio di Farmacocinetica - Vers. 1.0 - 01.05.2020 - Obiettivo: valutare l'associazione tra le concentrazioni plasmatiche del farmaco e gli endpoint clinici.
    E.3Principal inclusion criteria
    • Age (>=18 years)
    • Positivity at RT-PCR per SARS_CoV-2 (nasopharyngeal swabs)
    • COVID-19 Severity Score < 3
    • Patient able to take oral drugs
    • Informed consent to study participation and to personal data treatment
    Criterio di inclusione
    • Età (> = 18 anni)
    • Positività a RT-PCR per SARS_CoV2 (tampone nasofaringeo)
    • COVID-19 Severity Score <3
    • Paziente in grado di assumere farmaci per via orale
    • Consenso alla partecipazione allo studio e al trattamento dei dati personali
    E.4Principal exclusion criteria
    Exclusion criteria:
    • Pregnant or lactating women (pregnancy test not required, if doubt patient is excluded)
    • Subjects suffering from known CNS diseases
    • Lack of (or inability to provide) informed consent
    • Patient under dialysis
    • Any severe medical condition with a prognosis of < 6 months
    • Patients under warfarin treatment
    • Patients under antiviral treatment
    • Patients under chloroquine phosphate or hydroxychloroquine
    Criteri di esclusione
    • Donne in gravidanza o in allattamento (non è richiesto il test di gravidanza, in caso di dubbio la paziente viene esclusa)
    • Soggetti che soffrono di malattie del SNC note
    • Mancanza (o incapacità di fornire) un consenso informato
    • Paziente in dialisi
    • Qualsiasi condizione medica grave con una prognosi inferiore a 6 mesi
    • Pazienti in trattamento con warfarin
    • Pazienti sottoposti a trattamento antivirale
    • Pazienti in trattamento con clorochina fosfato o idrossiclorochina
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of serious adverse drug reaction (SADR).
    2. Quantitative viral load at Day 7 as measured by quantitative, digital droplet PCR.

    NB: The primary outcome no.2., as well as all secondary outcomes, will be measured only if the number of SADR is less than 4 in at least one of the treatment arms.
    1. numero di reazioni avverse gravi al farmaco (SADR)
    2. Carica virale quantitativa al giorno 7, misurata mediante PCR digitale

    Nota: L'endpoint primario n. 2 e gli endpoints secondari verranno valutati solo se il numero delle SADR sarà inferiore a 4 in almeno uno dei bracci di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    GIorno 14
    E.5.2Secondary end point(s)
    Trend over time of quantitative viral load at Day 7, 14 and Day 30 as measured by quantitative, digital droplet PCR.; Time to clinical resolution (for symptomatic patients).; Proportion of patients with virological clearance at day 14 and 30; Rate of hospitalization.; COVID-19 Severity Score at Day 14 and Day 30
    Andamento nel tempo della carica virale misurata mediante PCR quantitativa digitale ai giorni 7, 14 e 30; Tempo alla guarigione clinica (per i pazienti sintomatici); Percentuale di pazienti con clearance virale ai giorni 14 e 30; Tasso di ospedalizzazione; COVID-19 Severity Score ai giorni 14 e 30
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, 14 and 30; During the follow-up period; Day 14 and 30; During the follow-up period; Day 14 and 30
    Giorni 7,14 e 30; Durante i 30 giorni di follow-up; Giorni 14 e 30; Durante tutto il periodo di follow-up.; Giorni 14 e 30
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    LPLV
    LPLV
    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 months6
    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 months6
    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: 67
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 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 2020-08-10. 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 122
    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)
    -
    -
    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 Decision2020-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-28
    P. End of Trial
    P.End of Trial StatusOngoing
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