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    The EU Clinical Trials Register currently displays   38527   clinical trials with a EudraCT protocol, of which   6332   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
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    Summary
    EudraCT Number:2020-001608-40
    Sponsor's Protocol Code Number:HS216C17(MRCT)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-001608-40
    A.3Full title of the trial
    A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating the Efficacy and Safety of Favipiravir in the Treatment of Adult Patients with COVID-19-Moderate Type
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating the Efficacy and Safety of Favipiravir in the Treatment of Adult Patients with COVID-19-Moderate Typ
    A.4.1Sponsor's protocol code numberHS216C17(MRCT)
    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 SponsorZhejiang Hisun Pharmaceutical Co. Ltd.
    B.1.3.4CountryChina
    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 supportZhejiang Hisun Pharmaceutical Co. Ltd.
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOpera CRO Srl
    B.5.2Functional name of contact pointClinical Research Organization
    B.5.3 Address:
    B.5.3.1Street Address10, Cozia Street
    B.5.3.2Town/ cityTimisoara
    B.5.3.3Post code300209
    B.5.3.4CountryRomania
    B.5.4Telephone number0040256200353
    B.5.5Fax number0040256200353
    B.5.6E-mailcristina.igrisan@operacro.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.3.4Pharmaceutical 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.3.9.2Current sponsor codena
    D.3.9.3Other descriptive nameFAVIPIRAVIR
    D.3.9.4EV Substance CodeSUB128424
    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
    COVID-19
    E.1.1.1Medical condition in easily understood language
    viral infection with novel coronavirus SARS-COV-2
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    1. Time from randomization to clinical recovery
    Defined as: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72h.
    Criteria for normalization or relief:
    - Pyrexia (body temperature): axillary ≤36.9℃,or oral ≤37.4℃,or rectal or axillary tympanic ≤37.9℃;
    - Respiratory rate: ≤24/min without oxygen inhalation;
    - SPO2: >94% without oxygen inhalation;
    - Cough: Subject-perceived improvement or resolution of cough.
    E.2.2Secondary objectives of the trial
    Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization, Incidence of deterioration/aggravation of pneumonia within 28 days of randomization, Time from randomization to resolution of pyrexia within 28 days of randomization, Time from randomization to relief of cough within 28 days of randomization, It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0:Mild: Requires non-prescription treatment;Moderate: Requires medication treatment; limits instrumental activities of daily living;Severe: Limits self-care activities of daily living
    Time from randomization to relief of dyspnoea within 28 days of randomization, Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization;, ICU admission rate within 28 days of randomization, All-cause mortality within 28 days of randomization
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures
    2.Age 18-75 years (inclusive) at the time of signing ICF
    3.Being confirmed with COVID-19-Moderate type according to Competent Authority and Ministry of Health and respective country guidelines and recommendations reported in Appendix 1(a, b, c, d) to the present protocol. Based on comprehensive analysis and judgement taking into account both the epidemiological history and clinical manifestations, the diagnosis is to be confirmed for suspected cases or suspected cases/clinically diagnosed cases with all of the following etiological evidences:
    -Positivity in RT-PCR 2019-nCov test on respiratory tract specimens;
    -High homology with known gene sequence of 2019-nCov in viral gene sequencing on respiratory tract specimens
    Note: The above criterion would be subject to any update of the respective country guidelines and recommendations reported in Appendix 1 (a, b, c, d) to the present protocol. In case any new etiologically detection methods/criteria or any new detectable specimens become available after confirmed diagnosis, it is at the discretion of the investigator whether or not to use the new methods or new specimens
    4.Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia; if CT cannot be performed, Pneumonia confirmed by X-ray may be used. The method of chest imaging pneumonia diagnosis must be consistent all through the study period
    5.Patients with pyrexia (axillary ≥37℃ or oral ≥ 37.5℃, or tympanic or rectal≥38℃) or either respiratory rate >24/min and <30/min or cough; For not hospitalized patients, the Investigator should maintain the detection method consistent through study period
    6.The interval between symptoms onset and randomization is no more than 10 days; symptoms onset is primarily based on pyrexia, and can be based on cough or other related symptoms for patients without experiencing pyrexia following onset (it is strongly recommended that the interval between symptoms onset and randomization should not exceed 5 days)
    7.For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test. Menopause is defined as amenorrhea for at least 12 months without other medical cause, with the following age-specific requirements:
    -For female subjects aged <50 years: menopause for at least 12 months following withdrawal of exogenous hormonal therapy, with LH or FSH within the post-menopausal ranges, or having undergone any contraceptive surgery (bilateral oophorectomy or hysterectomy)
    -For female subjects aged ≥ 50 years: menopause for at least 12 months following withdrawal of exogenous hormonal therapy, or having undergone radiotherapy-induced oophorectomy with amenorrhea >1 year, or having undergone chemotherapy-induced menopause with amenorrhea>1 year, or having undergone any contraceptive surgery (bilateral oophorectomy or hysterectomy)
    8.Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 3 months (in male) and 1 month (in female)following the last study treatment; in addition:
    a.For female participants of childbearing potential only highly effective methods (failure rate < 1 %) plus one barrier method is allowed throughout the period of relevant systemic exposure with Favipiravir. Double barrier methods alone are not considered as highly effective. Additionally, pregnancy testing at baseline only is not deemed sufficient and must be repeated more frequently, at least if clinical signs of pregnancy occur and at follow-up / end of study
    b.male participants, if vasectomized or not, must wear a condom each time having heterosexual intercourse throughout the period of relevant systemic exposure with Favipiravir (as it is distributed to seminal fluid)
    c.male participant must be instructed not to have intercourse with pregnant women throughout the period of relevant systemic exposure with Favipiravir
    d.For further details on contraception in clinical trials, please refer to the CTFGguidance:https://www.hma.eu/fileadmin/dateien/Human_Medicines/01- About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf
    9.Not participating in any other interventional drug clinical studies before completion of the present study
    E.4Principal exclusion criteria
    1. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely;
    2. Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Favipiravir;
    3. Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN;
    4. Gout/history of gout or hyperuricemia (above the ULN);
    5. Oxygen saturation (SPO2) ≤93% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) ≤300 mmHg;
    6. Known allergy or hypersensitivity to Favipiravir or any of its excipients, or to placebo excipients (please see page 64);
    7. Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
    CrCl is to be calculated by the following Cockcroft-Gault formula only when the serum creatinine is>1.5×ULN
    8. Possibility of the subject being transferred to a non-study hospital within 72h;
    9. Pregnant or lactating women;
    10. Having used Favipiravir or participated in any other interventional drug clinical study within 30 days prior to first dose of study drug or having received treatments with other Investigational Medicinal Products (IMPs) or previous therapies within two weeks or five times the half-life of the drug, whichever is longer, must lead to exclusion
    11. Persons, who were placed in an institution due to official or legal orders should be excluded
    12. Persons, who are dependent on the sponsor, the investigator or the trial site, meaning that the voluntary nature of their consent is no longer guaranteed, must be excluded from participation
    Note: Considering that COVID-19 requires immediate treatment, absence of severe hepatic/renal disorders (e.g., cirrhosis, long-term dialysis) in the medical record can be used as an evidence for eligibility determination. It is recommended that hepatic function and creatinine be examined whenever possible.
    E.5 End points
    E.5.1Primary end point(s)
    1. Time from randomization to clinical recovery
    Defined as: The duration from start of treatment (Favipiravir or placebo) to normalization of pyrexia, respiratory rate and SPO2 and relief of cough (where there are relevant abnormal symptoms at enrolment) that is maintained for at least 72h.
    Criteria for normalization or relief:
    - Pyrexia (body temperature): axillary ≤36.9℃,or oral ≤37.4℃,or rectal or axillary tympanic ≤37.9℃;
    - Respiratory rate: ≤24/min without oxygen inhalation;
    - SPO2: >94% without oxygen inhalation;
    - Cough: Subject-perceived improvement or resolution of cough.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days (+/- 1 day) from randomization
    E.5.2Secondary end point(s)
    Secondary efficacy variables:
    1. Time from randomization to negativity in RT-PCR nucleic acid test for 2019-nCov within 28 days of randomization;
    2. Incidence of deterioration/aggravation of pneumonia (defined as SPO2 ≤93% or PaO2/FiO2 ≤300 mmHg or distressed RR ≥30/min without oxygen inhalation and requiring oxygen therapy or more advanced breath support) within 28 days of randomization;
    3. Time from randomization to resolution of pyrexia (defined the same as for the primary efficacy variable; applicable to subjects with pyrexia at enrolment) within 28 days of randomization;
    4. Time from randomization to relief of cough (defined the same as for the primary efficacy variable; applicable to subjects with cough at enrolment) within 28 days of randomization;
    It is recommended that the severity of cough be graded as per NCI-CTCAE v5.0:
    - Mild: Requires non-prescription treatment;
    - Moderate: Requires medication treatment; limits instrumental activities of daily living;
    - Severe: Limits self-care activities of daily living
    5. Time from randomization to relief of dyspnoea (defined as subject-perceived improvement or resolution of dyspnoea; applicable to subjects with dyspnoea at enrolment) within 28 days of randomization;
    6. Rate of auxiliary oxygen therapy or non-invasive ventilation within 28 days of randomization;
    7. ICU admission rate within 28 days of randomization(except patients already enrolled in ICU which respect eligibility criteria);
    8. All-cause mortality within 28 days of randomization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 Days (+/-1) from randomization
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    China
    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
    Last Patient Last Visit
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 256
    F.4.2.2In the whole clinical trial 256
    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)
    patients will be treated (if it is the case) after study end in the study hospital according to hospital implemented treatment protocol for COVID-19
    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 Decision2020-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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