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    Summary
    EudraCT Number:2021-002009-85
    Sponsor's Protocol Code Number:CF101-241COVID-19
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-20
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2021-002009-85
    A.3Full title of the trial
    Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
    Пиклиденозон за лечение на COVID-19 – Рандомизирано, двойно-заслепено, плацебо-контролирано пилотно изпитване.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Piclidenoson for Treatment of COVID-19 - A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
    Пиклиденозон за лечение на COVID-19 – Рандомизирано, двойно-заслепено, плацебо-контролирано пилотно изпитване.
    A.4.1Sponsor's protocol code numberCF101-241COVID-19
    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 SponsorCan-Fite BioPharma, Ltd.
    B.1.3.4CountryIsrael
    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 supportCanFite BioPharma Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCanFite BioPharma Ltd.
    B.5.2Functional name of contact pointDirector Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address10 Bareket Street, Kiryat Matalon
    B.5.3.2Town/ cityPetach Tikva
    B.5.3.3Post code49170
    B.5.3.4CountryIsrael
    B.5.4Telephone number+9723924 1114
    B.5.5Fax number+9723924 9378
    B.5.6E-mailzivit@canfite.co.il
    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 namePiclidenoson
    D.3.2Product code CF101
    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 INNPiclidenoson
    D.3.9.1CAS number 152918-18-8
    D.3.9.2Current sponsor codeCF101
    D.3.9.3Other descriptive nameIB-MECA
    D.3.9.4EV Substance CodeSUB214565
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    КОВИД-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    КОВИД-19
    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
    To evaluate the benefits of treatment with piclidenoson plus standard supportive care (SSC) (intervention arm) vs. placebo plus SSC (control arm) in hospitalized subjects with Moderate or Severe COVID-19. To evaluate the safety and tolerability of treatment with oral piclidenoson 2 mg every 12 hours (Q12H) in this population.
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hospitalized subjects 18 to 85 years of age, inclusive
    2. Able and willing to sign informed consent
    3. Molecular (RT-PCR) diagnosis of SARS-CoV-2 infection
    4. Moderate or Severe illness per NIH COVID-19 Treatment Guidelines:
    “Moderate” Illness: Symptoms such as cough, fever, sore throat, malaise, myalgias, headache; and Evidence of lower respiratory tract disease by clinical assessment and/or imaging; and SpO2 >93% on room air at sea level
    “Severe” Illness, including any of the following: Respiratory rate >30 breaths/minute; or SpO2 ≤93% on room air at sea level; or Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300; or Lung infiltrates >50% of pulmonary volume on imaging
    5. Female subjects must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of investigational product.
    6. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication. Female subjects of childbearing potential are all those except subjects who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal.
    a. For females: 2 of the following contraceptive methods, with at least 1 being a barrier method:
    - Hormonal contraceptives for ≥ 27 days before dosing
    - Intrauterine device (IUD) in place ≥ 27 days before dosing
    - Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from screening
    - Surgical sterilization of the partner (vasectomy ≥ 1 month before screening)
    - Female subjects must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of investigational product.
    b. For males:
    Surgical sterilization (vasectomy ≥ 1 month before screening)
    Or
    Both of the following contraceptive methods from screening:
    - Consistently and correctly use a condom
    - Partner must use a hormonal contraceptive or a nonhormonal barrier method (IUD or diaphragm with spermicide or cervical cap with spermicide).
    E.4Principal exclusion criteria
    1. “Critical” Illness, per NIH COVID-19 Treatment Guidelines, including any of the following: Respiratory failure; or Septic shock; or Multiple organ dysfunction
    2. Participation in another clinical trial concurrently
    3. Subjects who require mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
    4. Concurrent treatment with immunomodulators or anti-rejection drugs
    5. Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
    6. History of any of the following diseases or conditions:
    - Advanced or decompensated liver disease (including presence or history of bleeding varices, ascites, encephalopathy, or hepato-renal syndrome)
    - Inability to swallow tablets, or gastrointestinal disease which could interfere with the absorption of piclidenoson

    - Any malignancy within 5 years before screening; exceptions are superficial dermatologic malignancies (e.g., squamous cell or basal cell skin cancer treated with curative intent)
    - Cardiomyopathy, significant ischemic cardiac or cerebrovascular disease (including history of angina, myocardial infarction, or interventional procedure for coronary artery disease), or cardiac rhythm disorder
    - QTcF interval on an average of triplicate ECGs >450 milliseconds (msec) for males or >470 msec for females (except when QT prolongation is associated with right or left bundle branch block, in which case enrollment is allowed)
    - Any condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, congenital Long QT Syndrome

    - Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades de Pointes (https://crediblemeds.org/) unless the subject can be screened and monitored under the guidelines proposed by Giudicessi (2020)
    -Pancreatitis
    -Severe or uncontrolled psychiatric disorder, e.g., depression, manic condition, psychosis, acute and/or chronic cognitive dysfunction, suicidal behavior, and relapse of substance abuse
    - Active seizure disorder defined by either an untreated seizure disorder or continued seizure activity within the preceding year despite treatment with anti-seizure medication
    - Bone marrow or solid organ transplantation
    - Any serious condition that, in the opinion of the investigator, would preclude evaluation of response or make it unlikely that the contemplated course of therapy and follow-up could be completed
    7. Any of the following abnormal laboratory tests: Platelet count <90,000 cells/mm3 Absolute neutrophil count (ANC) <1,500 cells/mm3 Estimated creatinine clearance (CrCl) <50 mL/min by Cockcroft-Gault formulation Bilirubin level ≥2.5 mg/dL unless due to Gilbert’s syndrome AST or ALT level ≥3X the upper limit of normal Serum albumin level <3.0 g/dL International normalized ratio (INR) ≥1.5 (except subjects maintained on anticoagulant medications)
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    • Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or ECMO) at Day 29
    • Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29
    • Clinical status at Day 29 on NIAID 8-point ordinal scale (NIH 2020):
    1. Not hospitalized, no limitations
    2. Not hospitalized, with limitations
    3. Hospitalized, no active medical problems
    4. Hospitalized, not on oxygen
    5. Hospitalized, on oxygen
    6. Hospitalized, on high-flow oxygen or noninvasive mechanical ventilation
    7. Hospitalized, on mechanical ventilation or ECMO
    8. Death
    • Time (days) to improvement of 2 points on 8-point ordinal clinical scale
    • Incidence of mechanical ventilation
    • Ventilator-free days to Day 29
    • Incidence of Intensive Care Unit (ICU) admission
    • Duration (days) of ICU stay
    • Time (days) to hospital discharge
    • Duration (days) of need for supplemental oxygen
    • SARS-CoV-2 viral load by quantitative RT-PCR
    • Time (days) to virus negativity by RT-PCR, defined as absence of SARS-CoV-2 on 2 consecutive days of sampling
    • Changes in serum cytokine levels
    Safety endpoints:
    • Incidence, nature, and severity of treatment-emergent and treatment-related severe adverse events (SAEs)
    • Incidence of AEs leading to early discontinuation of trial treatment
    • Incidence of treatment-emergent changes in clinical laboratory parameters (CBC, chemistry, coagulation, urinalysis)
    • Incidence of treatment-emergent changes in vital signs, ECGs, and physical examination results
    • Incidence of meeting safety-related stopping rules
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Israel
    Bulgaria
    Romania
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 100
    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)
    standard of care
    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 Decision2021-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-06
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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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