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    The EU Clinical Trials Register currently displays   41039   clinical trials with a EudraCT protocol, of which   6717   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001971-33
    Sponsor's Protocol Code Number:CORIVER
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-001971-33
    A.3Full title of the trial
    Pragmatic study "CORIVER": Ivermectin as antiviral treatment for patients infected by SARS-COV2 (COVID-19)
    PRUEBA DE CONCEPTO “CORIVER”: IVERMECTINA COMO TRATAMIENTO ANTIVÍRICO EN PACIENTES INFECTADOS POR EL SARS-COV2 (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pragmatic study "CORIVER": Ivermectin as antiviral treatment for patients infected by SARS-COV2 (COVID19)
    PRUEBA DE CONCEPTO “CORIVER”: IVERMECTINA COMO TRATAMIENTO ANTIVÍRICO EN PACIENTES INFECTADOS POR EL SARS-COV2 (COVID19)
    A.3.2Name or abbreviated title of the trial where available
    CORIVER
    A.4.1Sponsor's protocol code numberCORIVER
    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 SponsorCarmen Hidalgo
    B.1.3.4CountrySpain
    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 supportHospital Universitario Virgen de las Nieves
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Virgen de las Nieves
    B.5.2Functional name of contact pointSergio Sequera
    B.5.3 Address:
    B.5.3.1Street AddressAvd. Fuerzas Armadas 2
    B.5.3.2Town/ cityGranada
    B.5.3.3Post code18014
    B.5.3.4CountrySpain
    B.5.4Telephone number+34958895414
    B.5.6E-mailsergiosequera15@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 Ivermectin
    D.2.1.1.2Name of the Marketing Authorisation holderx
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameIvermectin
    D.3.2Product code Ivermectin
    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.3.8INN - Proposed INNIvermectin
    D.3.9.3Other descriptive nameIVERMECTIN
    D.3.9.4EV Substance CodeSUB12089MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Dolquine
    D.2.1.1.2Name of the Marketing Authorisation holderPRODUCTS AND TECHNOLOGY S.L.,
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namedolquine
    D.3.2Product code Hydroxychloroquine
    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.3.8INN - Proposed INNHydroxychloroquine
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeSUB08077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Azitromicina Vir 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderIndustria Química y Farmacéutica VIR, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameazithromycin
    D.3.2Product code azithromycin
    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.3.8INN - Proposed INNAZITHROMYCIN
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.9.4EV Substance CodeSUB05660MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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
    SARS-COV2
    SARS-COV2
    E.1.1.1Medical condition in easily understood language
    New Coronavirus infection
    Infección por el coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    To evaluate efficacy and safety of the use of Ivermectin in the treatment of SARS-COV2 ambulatory patients.
    Evaluar la eficacia y seguridad del tratamiento con Ivermectina en el tratamiento de infección por SARS-COV2 ambulatorios.
    E.2.2Secondary objectives of the trial
    To analyze clinical parameters
    To evaluate the
    1. To Analyze the improvement in clinical parameters (symptoms and physical examination).
    2. To Assess the clinical cure rate after 2 weeks of treatment.
    3. To Evaluate the microbiological cure rate 72 h after treatment.
    4. To Assess the failure rate and admission requirements for disease progression.
    5. To Analyze the factors of weak or poor response to ivermectin.
    6. To Analyze adverse events to treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients over 50 years of age with comorbidities, diagnosed with SARS-Cov 2 infection by PCR or another diagnostic test performed in the emergency department, who are in the first week of clinic, without pneumonia and without admission criteria.
    • Patients between 18 and 70 years old (both inclusive) with pneumonia associated to SARS-Co2 infection: Cough or expectoration and / or fever> 38ºC + - Radiological infiltrate in Rxtórax; with SARS-Co2 PCR or radiological, clinical and analytical findings of COVID-19.
    • Evolution time of initial symptoms between 3 and 8 days.
    • Basal oxygen saturation> = 93% by breathing ambient air.
    • Have signed the informed consent.
    • Pacientes mayores de 50 años y comorbilidades con diagnóstico de infección por SARS-Cov 2 diagnosticados mediante PCR u otro test diagnóstico realizado en urgencias, que se encuentre en la primera semana de clínica, sin Neumonía y sin criterios de ingreso.
    • Pacientes entre 18 y 70 años (ambos inclusive) con neumonía asociada a infección por SARS-Co2: Tos o expectoración y/o fiebre > 38ºC + - Infiltrado radiológico en Rxtórax; con PCR SARS-Co2 o hallazgos radiológicos, clínicos y analíticos de COVID-19.
    • Tiempo de evolución de sintomatología inicial entre 3 y 8 días.
    • Saturación basal de oxígeno >= 93% respirando aire ambiente.
    • Que hayan firmado el consentimiento informado.
    E.4Principal exclusion criteria
    • Patients with Pneumonia due to SARS-COV2 that requires hospital admission, due to multilobar involvement, respiratory failure P02 <93% ambient air or <92% for COPD patients; with analytical criteria of severity (D-dimer> 600, CRP> 50, lymphopenia <900, ferritin> 700 mg / dL, Il-6 or organ failure of the organ or who have significant comorbidities: Renal insufficiency> 3B; immunosuppression, cancer; chronic cirrhosis or liver disease, diabetes mellitus, atherosclerosis of any territory, heart rhythm disturbances (including prolonged QT), poorly controlled HT.
    • Patients with QT range > 500ms.
    • Patients under 18 years of age.
    • Chilg-Pugh C liver failure.
    • Impossibility of giving treatment for non-suppressible drugs with the risk of QT prolongation or interactions (antidepressants, antihistamines, quinolones, statins except pitavastatin) or allergy to the drug.
    • Taking any of the drugs in the trial within 7 days prior to inclusion in the study
    • Pregnancy, lactation
    • Pacientes con Neumonía por SARS-COV2 que requiera ingreso hospitalario, por afectación multilobar, insuficiencia respiratoria P02 < 93% aire ambiente o <92% para pacientes EPOC; con criterios analíticos de gravedad (Dímero D >600, PCR >50, linfopenia< 900, ferritina >700 mg/dL, Il-6 o fracaso de órgano de órgano o que tengan comorbilidades significativas: Insuficiencia renal >3B; inmunosupresión, cáncer; cirrosis o hepatopatía crónica, diabetes mellitus, aterosclerosis de cualquier territorio, alteraciones del ritmo cardiaco (incluida QT prolongado), HTA mal controlada.
    • Pacientes con QT >500ms.
    • Pacientes menores de 18 años.
    • Insuficiencia hepática Chilg-Pugh C.
    • Imposibilidad de dar tratamiento por fármacos no suprimibles con riesgo de prolongación QT o interacciones (antidepresivos, antihistamínicos, quinolonas, estatinas salvo pitavastatina)o alergia al medicamento.
    • Toma de alguno de los fármacos en ensayo de en los 7 días previos a la inclusión en el estudio
    • Embarazo, lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be measured by comparing clinical cure, Microbiology, need for hospital admission due to clinical or analytical, blood gas and / or radiological deterioration for each arm.
    La eficacia se medirá comparando curación clínica, Microbiologia, necesidad de ingreso hospitalario por empeoramiento clínico o analítico, gasometrico y/o radiológico para cada brazo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two weeks since the start of the tratment
    A las dos semanas del inicio del tratamiento
    E.5.2Secondary end point(s)
    x
    x
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two weeks since the start of the tratment
    A las dos semanas del inicio del tratamiento
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state45
    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)
    None
    Ninguno
    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 Decision2020-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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