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    Summary
    EudraCT Number:2020-006042-39
    Sponsor's Protocol Code Number:HUN-FAVI-02
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-12
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-006042-39
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Favipiravir-HU compared to placebo as add-on therapy to standard of care in asymptomatic to mild severity COVID-19 patients
    Randomizált, kettős vak, placebo kontrollált vizsgálat a Favipiravir-HU hatásosságának és biztonságosságának vizsgálatára SOC kiegészítő terápiaként alkalmazva, placebohoz viszonyítva tünetmentes vagy enyhe súlyosságú COVID-19 betegek esetén
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of Favipiravir
    A.3.2Name or abbreviated title of the trial where available
    Favipiravir Clinical Trial
    A.4.1Sponsor's protocol code numberHUN-FAVI-02
    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 SponsorHungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium
    B.1.3.4CountryHungary
    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 supportHECRIN Consortium
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdWare Research Ltd.
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressVölgy street 41.
    B.5.3.2Town/ cityBalatonfüred
    B.5.3.3Post code8230
    B.5.3.4CountryHungary
    B.5.6E-mailkrisztina.hracs@adwareresearch.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.2.1.1.1Trade name Favipiravir HU 200 mg hard capsules
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 HU 200 mg hard capsules
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule, hard
    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 with PCR confirmed SARS-CoV-2 infection who are
    asymptomatic or have mild symptoms will be enrolled
    E.1.1.1Medical condition in easily understood language
    Patients with confirmed COVID-19 disease
    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 primary objective is to assess the efficacy of Favipiravir-HU compared to placebo as add-on treatment on reducing SARS-CoV-2 virus copy number as measured by quantitative PCR by nasopharyngeal sampling.
    E.2.2Secondary objectives of the trial
    Key secondary objectives
    • To assess the study treatment’s effect on reduction of the time required for virus elimination.
    • To assess the study treatment’s risk reduction effect.
    • To assess the recovery time in patients who have developed symptoms, using clinical and radiological diagnostics
    • To evaluate the safety and tolerability of the investigational product.
    Secondary objectives
    • To assess the study treatment’s risk reduction effect on overall mortality.
    • To assess the study treatment’s risk reduction effect on achieving development of respiratory failure.
    • To assess the study treatment’s risk reduction effect on need for intensive care unit.
    • To assess the study treatment’s risk reduction effect on need for non-invasive respiratory support.
    • To assess the study treatment’s risk reduction effect on need for invasive respiratory support.
    • To assess the study treatment’s risk reduction effect on Acute Respiratory Distress Syndrome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female patients between the ages of 18 and 65 years
    Patients with PCR confirmed SARS-CoV-2 infection
    Asymptomatic or have mild only symptoms
    Signed Informed Consent Form and Patient Information Leaflet
    E.4Principal exclusion criteria
    Pregnant or possibly pregnant patients or lactating females
    Patients have moderate to severe or immediately life-threatening COVID-19
    Major risk factor onset (Obesity, Diabetes, COPD, Hypertension)
    Patients with SpO2 less than 95% without oxygen therapy
    Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification
    Patients with renal impairment requiring dialysis
    Patients with disturbed consciousness such as disturbed orientation
    Female patients who are woman of childbearing potential and unable to consent to use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with orwithout a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation
    Male patients whose are unable to consent to use of barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm in 90 days after the start of favipiravir administration.
    Patients with hereditary xanthinuria
    Patient with severe uncontrolled hyperuricaemia
    Patients receiving immunosuppressant
    Patients who received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 72 hours or Patients who receive forbidden concomitant medication
    Any medical condition that the examining physician deems unsuitable for the patient to participate in the study
    E.5 End points
    E.5.1Primary end point(s)
    <PRIM1> The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day6 of the study
    E.5.2Secondary end point(s)
    <KSEC1> Time to virus elimination: number of days from treatment start to virus elimination
    <KSEC2> Proportion of patients achieving more severe stages of COVID-19
    <KSEC3> Time to recovery in patients who have developed symptoms
    <KSEC4> Number and proportion of patients with at least 1 adverse event related to study treatment

    Secondary endpoints of the study are as follows:
    <SEC1> Overall mortality rate
    <SEC2> Proportion of patients with respiratory failure
    <SEC3> Proportion of patients with need for intensive care
    <SEC4> Proportion of patients with need for non-invasive respiratory support
    <SEC5> Proportion of patients with need for invasive respiratory support
    <SEC6> Proportion of patients with Acute Respiratory Distress Syndrome
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day28 -last visit
    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 Yes
    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 concerned3
    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 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
    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 months6
    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: 120
    F.1.3Elderly (>=65 years) No
    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 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 state120
    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
    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 Decision2021-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-12-08
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