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    Summary
    EudraCT Number:2020-002322-85
    Sponsor's Protocol Code Number:KAN0006
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-14
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-002322-85
    A.3Full title of the trial
    KAND567 Versus Placebo in Subjects Hospitalized with COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    KAND567 Versus Placebo in Subjects Hospitalized with COVID-19. A Phase II, Randomized, 2-Arm Parallel-Group, Double-blind Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics.
    A.4.1Sponsor's protocol code numberKAN0006
    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 SponsorKancera AB
    B.1.3.4CountrySweden
    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 supportKancera AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScandinavian CRO AB
    B.5.2Functional name of contact pointAnna Runeson
    B.5.3 Address:
    B.5.3.1Street AddressBox 150 27
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post codeSE-750 15
    B.5.3.4CountrySweden
    B.5.4Telephone number+46703033508
    B.5.6E-mailanna.runeson@scro.se
    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 nameKAND567
    D.3.2Product code KAND567
    D.3.4Pharmaceutical form Capsule
    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
    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
    Acute respiratory distress syndrome (ARDS) in COVID-19 infection
    E.1.1.1Medical condition in easily understood language
    Acute respiratory distress syndrome (ARDS) in COVID-19 infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    The primary objective is to assess the impact of oral administration of KAND567 versus placebo, in COVID-19 subjects admitted to the hospital for care of COVID-19 infection with respect to: Rates of adverse events (AEs), serious adverse events (SAEs) and safety lab data.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine and compare the effects of oral administration of KAND567 versus placebo, on:
    a. Oxygen exchange and respiration in subjects admitted to the hospital for care of COVID-19 infection.
    b. Clinical outcome measures reflecting the severity and progression of disease.
    c. The effect on different types of leukocytes and cytokines.
    Further, the study will evaluate the population pharmacokinetics (PK) of KAND567 after oral administration to COVID-19 subjects, and by sparse blood gas sampling add an estimate of PaO2 to confirm non-invasive measurements of oxygenation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written Informed Consent obtained and documented according to ICH/GCP and national/local regulations prior to any study-specific procedure.
    2. Males and females aged ≥18-85 years at the time of signing the informed consent form. Female subjects must be post-menopausal or use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subject must be willing to use condoms with spermicide, and if he has a fertile partner, she must use contraceptive methods with a failure rate of < 1% to prevent pregnancy*. Male subjects must also refrain from donating sperm from the first dose until three months after dosing with investigational product (IP).
    * Combined (estrogen- and progesterone-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 (IUD) or intrauterine hormone-releasing system (IUS); bilateral tubal occlusion, vasectomy, sexual abstinence
    3. Patients with symptoms and signs of SARS-CoV-2 infection according to WHO case definition. Symptoms must include shortness of breath, with an onset which occurred ≤ 10 days before admission, and the COVID-19 diagnosis must be confirmed by laboratory testing (PCR-positive). In addition, moderately impaired oxygenation as demonstrated by oxygen saturation ≤ 93% but ≥ 87% on room air, or requiring 1-5 L/min of oxygen to obtain an oxygen saturation of ≥ 92%, and at least one of the following laboratory values:
    A. Ferritin: > 300 ng/mL for men and > 150 ng/mL for women
    B. C-reactive protein (CRP): ≥ 10 mg/L
    C. D-dimer elevated above the age-adjusted lower limit:
    i. ≤ 50 years; < 0.5 mg/L FEU
    ii. > 50 years; age-related, calculated as follows: 0.5 mg/L FEU + 0.01 mg/L FEU for every year over 50 (i.e. one who is 70 years old has thus a reference limit of < 0.7 mg/L FEU; on who is 90 years old has a reference limit of < 0.9 mg/L FEU)
    4. Able to swallow capsules.
    5. Willingness and ability to comply with study procedures, visit schedules, study restrictions and requirements.
    E.4Principal exclusion criteria
    1. Patient not committed to aggressive management. For example, the subject, the subject's family or primary physician are unwilling to accept that the subject is placed on mechanical ventilation; or in the case of an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation.
    2. A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19).
    3. Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times the upper limit of normal (ULN) detected at screening (per local lab) or suspected liver disease.
    4. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure.
    5. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    6. Clinically verified pulmonary embolism
    7. Chronic inflammatory disease requiring treatment with oral corticosteroids in a dose higher than prednisone 10 milligrams (mg) or equivalent per day, or requiring treatment with other anti-inflammatory drugs (e.g. methotrexate).
    8. Use of strong CYP3A4 inhibitors (e.g. azoleantifungals, macrolide antibiotics, protease inhibitors) or inducers (e.g. rifabutin and rifampicin) and drugs sensitive to CYP3A4 inhibition (e.g. benzodiazepines, certain statins [lovastatin and simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]).
    9. Participation in another pharmaceutical clinical study.
    10. Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP).
    11. Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or ICU admission for any other cause than respiratory support.
    12. Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons.
    13. Active malignancy with or without treatment, except local basal cell carcinoma.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of Adverse Events and Serious Adverse Events

    E.5.1.1Timepoint(s) of evaluation of this end point
    After subject has signed informed consent and during participation in the study until final follow-up visit
    E.5.2Secondary end point(s)
    1. The assessment will be done by comparing the effects on the ROX index, defined as the ratio of oxygen saturation as measured by pulse oximetry/fraction-inhaled oxygen to respiratory rate (ROX = O2 Sat/FiO2 x RR), in the two treatment arms.
    b. Treatment failure rate, where treatment failure is defined as use of assisted
    invasive mechanical ventilation or death
    c. Time to assisted invasive mechanical ventilation (measured with hourly precision).
    d. Time to admission to ICU (measured with hourly precision).
    e. Number of days hospitalized.
    f. The WHO Covid-19 Ordinal Scale of Clinical Improvement
    3. The individual components of the ROX index
    4. The levels of different blood cells types and activity markers before and after administration of KAND567

    5. The fractalkine phenotype on T-cells, monocytes, NK-cells and neutrophils
    6. Plasma levels of cytokines such as IL-6 and the inflammation marker CRP before and after KAND567 administration

    7. The PK of the present study will be compared to PK as determined in the previous phase I clinical study KAN0001.
    8. PaO2/FiO2 change from baseline
    The safety endpoint parameters are frequency and severity of adverse events, vital signs, electrocardiography (ECG), results of safety laboratory tests and urinalysis.
    .
    E.5.2.1Timepoint(s) of evaluation of this end point
    After subject has signed informed consent and during participation in the study until final follow-up 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 EEA4
    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
    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 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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 No
    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 40
    F.4.2.2In the whole clinical trial 40
    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 Decision2020-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-07
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