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    Summary
    EudraCT Number:2020-002753-22
    Sponsor's Protocol Code Number:FAVID-01-20-SP
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-20
    Trial results View 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 number2020-002753-22
    A.3Full title of the trial
    Safety and Efficacy of Favipiravir in COVID-19 Patients with Pneumonia
    −A randomized, double blind, placebo- controlled study −
    Seguridad y eficacia de Favipiravir en pacientes COVID-19 con neumonía.
    − Un estudio aleatorizado, doble ciego y controlado con placebo −
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Favipiravir in COVID-19 Patients with Pneumonia
    −A randomized, double blind, placebo- controlled study −
    Seguridad y eficacia de Favipiravir en pacientes COVID-19 con neumonía.
    − Un estudio aleatorizado, doble ciego y controlado con placebo −
    A.4.1Sponsor's protocol code numberFAVID-01-20-SP
    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 SponsorFerrer Internacional, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFerrer Internacional, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerrer Internacional, S.A.
    B.5.2Functional name of contact pointRebeca Aldonza Aguayo
    B.5.3 Address:
    B.5.3.1Street AddressDiagonal 549
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number+034662 213 660
    B.5.6E-mailraldonza@ferrer.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 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 nameFavipiravir
    D.3.2Product code Favipiravir
    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 INNFAVIPIRAVIR
    D.3.9.1CAS number 259793-96-9
    D.3.9.4EV Substance CodeSUB194303
    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 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
    Patients diagnosed with COVID-19 by positive PCR for SARS-COV2
    Pacientes diagnosticados con COVID-19 mediante PCR positiva para SARS-COV2
    E.1.1.1Medical condition in easily understood language
    Coronavirus infection
    Infección por 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 PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective of the study is to evaluate the clinical safety and potential efficacy of favipiravir relative to the control arm in patients hospitalized with COVID-19
    El objetivo general del estudio es evaluar la seguridad clínica y potencial eficacia de favipiravir respecto al grupo control en pacientes hospitalizados con COVID-19
    E.2.2Secondary objectives of the trial
    The overall objective of the study is to evaluate the clinical safety and potential efficacy of favipiravir relative to the control arm in patients hospitalized with COVID-19
    El objetivo general del estudio es evaluar la seguridad clínica y potencial eficacia de favipiravir respecto al grupo control en pacientes hospitalizados con COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Adult age: from 18 to 85 years included (at the time of informed consent) of both genders
    2.Patients with categories 3 to 5 on the ordinal scale
    3.Patients who meet all of the following criteria 1), 2), 3), and 4) at the time of enrollment
    1)Patients who tested positive for SARS-COV2 on RT-PCR test from respiratory specimen(s)
    2)Patients with new lung lesions on chest images (chest x-ray, CT scan, etc.)
    3)Patients with SpO2 < 94%
    4)Patients who meet at least 2 of the following symptoms/findings:
    -Fever of 37.5°C or higher
    -Respiratory rate ≥ 24/min
    -Cough
    4.For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug
    5.Patients who understand the contents of this study and are able to provide written consent by themselves or by legally authorized representative
    6. During the influenza virus season, if the incidence is above the epidemic threshold, patients with a
    negative test resul
    1.Adultos de ambos géneros entre 18 y 85 años (incluidos) (en el momento de la firma del consentimiento informado)
    2.Pacientes entre las categorías 3 y 5 de la escala ordinal
    3.Pacientes que cumple todos los siguientes criterios en el momento de la inclusión:
    1)Pacientes con un test PCR positivo en muestra respiratoria para SARS-COV2
    2)Pacientes con imágenes de nuevas lesiones pulmonares diagnosticadas mediante rayos X, tomografía computarizada, etc.
    3)Pacientes con SpO2 < 94%
    4)Pacientes que cumplen al menos 2 de los siguientes síntomas:
    -Fiebre de 37.5°C o superior
    -Frecuencia resporatoria ≥ 24/min
    -Tos
    4.En el caso de mujeres pre-menopáusicas, test de embarazo en sangre negativo antes de la primera administración del fármaco en estudio.
    5.Pacientes que entienden el contenido del estudio y son capaces de firmar un consentimiento informado o bien delegarlo en un representante autorizado.
    6. Durante la temporada gripal, si la incidencia está por encima del umbral epidémico, pacientes con un resultado negativo en el test del virus de la gripe.
    E.4Principal exclusion criteria
    1.Patients who show increased procalcitonin levels (1 ng/ml or higher) before the start of study drug administration and are suspected to have concurrent bacterial infection
    2.Patients who show abnormal NT-pro BNP levels (400 pg/mL or higher) and are suspected to have concurrent congestive heart failure
    3.Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal limit)
    4.Patients with renal impairment requiring dialysis
    5.Patients with disturbed consciousness such as disturbed orientation (except with a nasogastric tube administration)
    6.Pregnant or possibly pregnant patients and lactating or nursing female patients
    7.Patients (and their partners) who desire to become pregnant during the study period or who cannot abstain from sex or who will not use contraceptives from the start of favipiravir until 14 days after end of administration
    8.Male patients whose partner cannot agree to use the contraception method described above (criterion 7)
    9.Patients who cannot consent to the use of condoms from the start of favipiravir administration to 14 days after the end of favipiravir administration
    10.Patients with hereditary xanthinuria
    11.Patients who have previously ever been diagnosed with hypouricemia (< 1 mg/dL) or xanthine urinary calculi
    12.Patients with a history of gout or on treatment for gout or hyperuricemia
    13.Patients receiving immunosuppressants (tocilizumab and corticosteroids administration is permitted)
    14.Other patients judged ineligible by the principal investigator or sub-investigator
    15.Known allergy to any study medication and its excipients
    16.Patients on the current treatment or who have been treated during last 7 days with remdesivir
    1.Pacientes con niveles de procalcitonina elevados (≥1 ng/ml) antes de la administración del fármaco en estudio y con sospecha de tener infecciones bacterianas recurrentes.
    2.Pacientes con niveles anormales de NT-pro BNP (≥400 pg/mL) y con sospecha de tener insuficiencia cardíaca congestiva recurrente.
    3.Pacientes con fallo hepático severo (>Grado 3: ALT >10 veces el LSN)
    4.Pacientes con fallo renal que requieran diálisis
    5.Pacientes con alteración de la conciencia, como orientación alterada (excepto con una administración de sonda nasogástrica)
    6.Pacientes embarazadas o con posibilidad de estarlo y en periodo de lactancia
    7.Pacientes (y sus parejas) que deseen quedarse embarazadas durante el periodo del estudio o que no estén dispuestos a abstenerse a tener sexo o a usar medidas contraceptivas desde el inicio del ensayo clínico y hasta transcurridos 14 días de la última administración.
    8.Pacientes varones cuyas parejas no estén de acuerdo en usar los métodos anticonceptivos descritos en el criterio 7
    9.Pacientes que no consientan en el uso de preservativos desde el inicio del ensayo hasta 14 días después de la última administración.
    10.Pacientes con xantinuria hereditaria
    11.Pacientes que hayan sido diagnosticados previamente con hipouricemia (< 1 mg/dL) o cálculos urinarios de xantina
    12.Pacientes con historia de gota o en tratamiento para gota o hiperuricemia
    13.Pacientes que estén recibiendo inmunosupresores (la administración de tocilizumab y corticosteroides está permitida)
    14.Otros pacientes que a juicio del investigador principal o el sub-investigador se consideren no elegibles
    15.Alergias conocidas a la medicación del estudio y sus excipientes
    16. Pacientes en tratamiento o que hayan sido tratados durante los últimos 7 días con remdesivir
    E.5 End points
    E.5.1Primary end point(s)
    Time to clinical improvement measured as improvement for ≥ two categories on a 7-point ordinal scale (Time frame: up to 28 days):
    1. Not hospitalized, no limitations on activities
    2. Not hospitalized, limitation on activities;
    3. Hospitalized, not requiring supplemental oxygen;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    7. Death.
    Tiempo de mejoría clínica medido como la mejoría en dos o más categorías en una escala ordinal de 7 puntos (marco de tiempo: hasta 28
    días):
    1. No hospitalizado, sin limitaciones en las actividades
    2. No hospitalizado, limitación de actividades
    3. Hospitalizado, que no requiere oxígeno suplementario
    4. Hospitalizado, que requiere oxígeno suplementario
    5. Hospitalizado, con ventilación no invasiva o dispositivos de oxígeno de
    alto flujo
    6. Hospitalizado, con ventilación mecánica invasiva u oxigenación por
    membrana extracorpórea (ECMO)
    7. La muerte
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time frame: up to 28 days
    Periodo de tiempo: hasta los 28 días
    E.5.2Secondary end point(s)
    1.Clinical Severity

    1)Ordinal scale:
    ▪ Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 28
    ▪ Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11 and 28

    2)National Early Warning Score (NEWS):
    ▪ The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
    ▪ Change from baseline to days 3, 5, 8, 11 and 28 in NEWS
    3)Oxygenation:
    ▪ Oxygenation free days in the first 28 days (if the patient is still hospitalized) or up to hospital discharge
    ▪ Incidence and duration of new oxygen use during the trial.
    4)Mechanical Ventilation:
    ▪ Ventilator free days in the first 28 days (if the patient is still hospitalized) or up to hospital discharge.
    ▪ Incidence and duration of new mechanical ventilation use during the trial.
    5)Hospitalization
    ▪ Duration of hospitalization (days).
    6)Mortality up to 28 days
    1.Gravedad clínica
    1) Escala ordinal
    ▪ Estado clínico del sujeto en una escala ordinal en los días 3, 5, 8, 11 y 28
    ▪ Cambio medio en la clasificación en una escala ordinal desde el inicio hasta los días 3, 5, 8, 11 y 28

    2) Puntuación en el National Early Warning Score (NEWS)
    ▪ El tiempo hasta el alta hospitalario o NEWS ≤ 2 mantenido durante 24
    horas, lo que ocurra primero
    ▪ Cambio desde basal hasta los días 3, 5, 8, 11 y 28 en NEWS
    3) Oxigenación
    ▪ Días libres de oxigenación en los primeros 28 días (si el paciente aún está hospitalizado) o hasta el alta hospitalaria
    ▪ Incidencia y duración del nuevo uso de oxígeno durante el ensayo
    4) Ventilación mecánica
    ▪ Días sin ventilación en los primeros 28 días (si el paciente aún está hospitalizado) o hasta el alta hospitalaria.
    ▪ Incidencia y duración del nuevo uso de ventilación mecánica durante el ensayo
    5) Hospitalización
    ▪ Duración de la hospitalización (días)
    6) Mortalidad hasta 28 días.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time frame: up to 28 days
    Periodo de tiempo: hasta los 28 días
    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 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) 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 concerned6
    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
    12 months
    12 meses
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 50
    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 No
    F.3.2Patients Yes
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state100
    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)
    Treatment according to usual clinical practice
    Tratamiento según práctica clínica habitual
    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 Decision2020-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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