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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7294   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:2020-001872-13
    Sponsor's Protocol Code Number:PTC299-VIR-015-COV19
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-03-11
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-001872-13
    A.3Full title of the trial
    Evaluation of the efficacy and safety of PTC299 in hospitalized subjects with COVID-19 (FITE19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy and safety of PTC299 in hospitalized subjects with COVID-19 (FITE19)
    A.3.2Name or abbreviated title of the trial where available
    FITE19
    A.4.1Sponsor's protocol code numberPTC299-VIR-015-COV19
    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 SponsorPTC Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportPTC Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPTC Therapeutics, Inc.
    B.5.2Functional name of contact pointPatient Advocacy
    B.5.3 Address:
    B.5.3.1Street Address100 Corporate Court
    B.5.3.2Town/ citySouth Plainfield
    B.5.3.3Post codeNJ 07080
    B.5.3.4CountryUnited States
    B.5.4Telephone number0119082227000
    B.5.6E-mailmedinfo@ptcbio.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 nameEmvododstat
    D.3.2Product code PTC299
    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 INNEmvododstat
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codePTC299
    D.3.9.3Other descriptive name(S)-PV-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Coronavirus disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019 (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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066740
    E.1.2Term Acute respiratory tract 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 primary objective of the study is to evaluate the clinical efficacy of PTC299 compared with placebo assessed by time to respiratory improvement in adult subjects hospitalized with COVID-19.
    E.2.2Secondary objectives of the trial
    • To evaluate the clinical efficacy of PTC299 compared with placebo, as assessed by respiratory function, immune response, length of hospitalization, and mortality.
    • To evaluate the safety of PTC299 as assessed by drug related adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject (or legally authorized representative) is willing and able to provide informed consent and comply with all protocol requirements.
    2. Agrees to the collection of nasopharyngeal swabs and venous blood and all other protocol-specified procedures.
    3. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
    4. Hospitalized and has laboratory-confirmed infection with SARS-CoV-2.
    5. Symptom onset was ≤14 days prior to Screening
    6. Has SpO2 <94% on room air
    7. Has at least one of respiratory rate >24 breaths/minute or cough
    8. Lung involvement as confirmed by radiographic infiltrates observed on imaging (chest X-ray, CT scan, or an equivalent test)
    9. Women of childbearing potential (as defined in (CTFG 2014)) must have a negative pregnancy test at screening and agree to abstinence or the use at least one of the following highly effective forms of contraception (with a failure rate of <1% per year when used consistently and correctly). Contraception or abstinence must be continued for the duration of the study following discharge from the hospital, and for up to 50 days after the last dose of study drug:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
    - oral
    - intravaginal
    - transdermal
    • progestogen-only hormonal contraception associated with inhibition of ovulation:
    - oral
    - injectable
    - implantable
    • intrauterine device
    • intrauterine hormone-releasing system
    • vasectomized partner with confirmed azoospermia´
    All females will be considered of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea in the appropriate age group without other known or suspected cause) or have been sterilized surgically (eg, bilateral tubal ligation, hysterectomy, bilateral oophorectomy).
    10. Men sexually active with women of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control during the study following discharge from the hospital and for up to 50 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1. Requires mechanical ventilation
    2. Current participation in any other interventional study.
    3. Severe liver disease as defined by alanine transaminase/aspartate transaminase levels (ALT/AST) >4 times the upper limit of normal.
    4. Lymphocyte count <500 lymphocytes/µL or hemoglobin <11.0 g/dL
    5. Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate <30)
    6. Any other condition, that in the opinion of the investigator, may be cause to exclude the subject from the study.
    7. Use of steroids (except dexamethasone), drugs metabolized by CYP2D6, CYP2C inducers, IL-6 neutralizing antibodies, IL-6 receptor inhibitors, or any investigational therapy.
    8. Pregnancy or breast feeding.
    9. Anticipated transfer to another hospital which is not a study site within 72 hours.
    10. Known allergy to PTC299 or excipients
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time from randomization to respiratory improvement, defined as peripheral oxygen saturation (SpO2) ≥94% on room air sustained until discharge from the hospital or the end of the study (Day 28).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is time from randomization to respiratory improvement, defined as SpO2 ≥94% on room air sustained until discharge from the hospital or the end of the study (Day 28).
    E.5.2Secondary end point(s)
    ● The proportion of subjects requiring invasive ventilation at any point during the study
    ● The proportion of subjects requiring supplemental oxygen or non-invasive ventilation at any point during the study in subjects who did not require supplemental oxygen at baseline
    ● Time from randomization to defervescence in subjects presenting with fever at enrollment (temperature of ≥37.6 °C axilla, ≥38.0 °Coral, or ≥38.6 °C tympanic or rectal)
    ● Time from randomization to respiratory rate ≤24 breaths/minute on room air
    ● Time from randomization to cough reported as mild or absent (in those with cough at enrollment rated severe or moderate)
    ● Time from randomization to dyspnea reported as mild or absent (on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate)
    ● Attenuation of immune responses as indicated by:
    ○ reduction in cytokine levels, potentially including interleukin (IL)-2, IL-6, IL 7, IL-17, G-CSF, IP-10, MCP-1, MIP1-α, and TNF-α
    ○ reduction in levels of acute phase proteins, potentially including ferritin, C reactive protein, D-dimer, and cardiac troponin
    ○ normalization in the complete blood count
    ● Changes in other laboratory parameters potentially including decreases in lactate dehydrogenase, prothrombin time, albumin
    ● Reduction in viral load
    ● Duration of hospitalization measured in days
    ● Mortality at Day 28
    ● Overall safety profile characterized by type, frequency, severity, timing, and relationship to study treatment of any adverse events (AEs) or laboratory abnormalities.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Similar to the primary endpoint, Kaplan-Meier estimate, median and rate at Days 7, 14, and 28 will be presented for overall survival, time from randomization to defervescence, time from randomization to respiratory rate ≤24 breaths/minute on room air, time from randomization to cough reported as mild or absent (in those with cough at enrollment rated severe or moderate), and time from randomization to dyspnea reported as mild or absent (on a scale of severe, moderate, mild, absent, in those with dyspnea at enrollment rated as severe or moderate).
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Brazil
    Mexico
    United States
    Belgium
    France
    Italy
    Poland
    Portugal
    Spain
    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
    The study will end when the last subject has completed the final assessment.
    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 months18
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 190
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 380
    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)
    Subjects will be treated according to standard of care as defined per local written policies or guidelines.
    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 Decision2022-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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