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    Summary
    EudraCT Number:2020-005849-16
    Sponsor's Protocol Code Number:KIN001-203
    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:2020-12-18
    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 number2020-005849-16
    A.3Full title of the trial
    An 8-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 development in hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An 8-week double-blind, randomized, placebo-controlled, phase II study evaluating the effects of oral pamapimod 150 mg with pioglitazone 10 mg daily on COVID-19 development in hospitalized patients infected with SARS-CoV-2 (severe acute respiratory syndrome-coronavirus-2)
    A.3.2Name or abbreviated title of the trial where available
    Kinarus COVID-19 Study
    A.4.1Sponsor's protocol code numberKIN001-203
    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 SponsorKinarus AG
    B.1.3.4CountrySwitzerland
    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 supportKinarus AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKinarus AG
    B.5.2Functional name of contact pointHead Project Management
    B.5.3 Address:
    B.5.3.1Street AddressHochbergerstrasse 60C
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4057
    B.5.3.4CountrySwitzerland
    B.5.6E-mailcorinne.peter@kinarus.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 namePioglitazone
    D.3.4Pharmaceutical form Prolonged-release 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 INNnot available
    D.3.9.3Other descriptive namePIOGLITAZONE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03834MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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.3.2Product code KIN001
    D.3.4Pharmaceutical form Film-coated 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 INNPAMAPIMOD
    D.3.9.1CAS number 449811-01-2
    D.3.9.2Current sponsor codeKIN001
    D.3.9.4EV Substance CodeSUB32898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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 development in hospitalized patients infected with SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    Hospitalized patients suffering from 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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 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 is to evaluate the percentage of participants who die or require non-invasive ventilation / high flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation (ECMO)) measured in the time frame from Day 0 to week 4 *
    * the indication for non-invasive ventilation or high-flow oxygen or invasive mechanical ventilation or ECMO is based on the judgement of the investigator. This includes patients qualifying for any of these therapies but not receiving it for reasons unrelated to the indication, e.g. patient refuses intubation, high-flow or mechanical ventilation or ECMO not available, general condition of patient too bad, etc.
    E.2.2Secondary objectives of the trial
    The secondary objectives for this study are:
    • Number of ventilator-free days (invasive mechanical ventilation) measured in the time fram from Day 0 to week 4
    • Number of invasive, high flow oxygenation, non invasive ventilation and ECMO free days measured in the time frame of Day 0 to week 4
    • To evaluate the reduction in mortality or severe respiratory failure as determined by need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/o ECMO until end of the study (measured at 8 weeks
    • To evaluate the all cause mortality measured at 4 and 8 weeks)
    • To evaluate the reduction in severe respiratory failure rate as defined by need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/or ECMO (by number of patients) at 4 weeks and end of study¬ (8 weeks)
    • To evaluate the safety and tolerability of pamapimod used in combination with pioglitazone
    • To determine length of hospitalization / ICU stay




    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of COVID-19 confirmed by a positive test for SARS-CoV-2 RNA by RT PCR in a specimen from the upper respiratory tract, lower respiratory tract or expectorated sputum or by a positive rapid antigen test for SARS-CoV-2
    2.Patients hospitalized due to symptomatic COVID-19 infection
    a.with a WHO progression score of 4 presenting with at least one of the following co-morbidities: cardiac arrhythmia, arterial hypertension, coronary heart disease, adipositas, chronic renal disease, chronic hepatic disease, active cancer, asthma, COPD, , diabetes mellitus, history of cerebrovascular disease, autoimmune disease, immunosuppression or age > 60 years
    or
    b. with a WHO progression score of 5 with or without comorbidities
    3. Patients being treated or having received off-label agents for COVID-19 (approved for another indication than COVID-19, such as dexamethasone or remdesivir) are eligible for the study
    4. Adult male or female patients aged ≥ 18 years
    5. Females must have a negative pregnancy test or must be post-menopausal
    6. Able to understand and willing to sign an IRB approved written informed consent document. For patients unable to understand and sign themselves, his/her legal representative will be informed and sings the informed consent document in countries where national law/regulations permit.
    E.4Principal exclusion criteria
    1. Patients participating in another clinical trial with a new investigational drug or an investigational non-drug treatment
    2. Known allergy or intolerance to pamapimod or any other ingredient of the IMP or another P38 inhibitor
    3. Known allergy or intolerance of clinical relevance to pioglitazone or any other ingredient of the IMP
    4. Patients where oral administration of pioglitazone is contraindicated (i.e. cardiac failure or history of cardiac failure (NYHA stages I to IV), hepatic impairment, diabetic ketoacidosis, current bladder cancer or a history of bladder cancer, uninvestigated macroscopic haematuria
    5. Any use of CYP450 2C8 inducers (e.g. rifampicin)
    6. Known or suspected active viral (including HIV, hepatitis B, hepatitis C), bacterial, mycobacterial or fungal infection other than COVID-19. Virologic testing not required unless infection is suspected.
    7. Pregnant or breastfeeding women
    8. Any uncontrolled concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator
    9. Liver enzyme elevation more than 3x above normal
    10. Patients who are detained or committed to an institution by a law court or by legal authorities (subject is vulnerable, such as deprived of freedom)
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants who die or require non-invasive ventilation / high-flow oxygen or invasive mechanical ventilation (including extracorporeal membrane oxygenation (ECMO)) measured in the time frame from Day 0 to week 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    E.5.2Secondary end point(s)
    • Number of ventilator-free days (invasive mechanical ventilation) measured in the time frame from D0 to week 4
    • Number of invasive ventilation, high-flow oxygenation, non invasive ventilation, and ECMO free days measured in the time frame of Day 0 to week 4
    • Reduction in mortality or severe respiratory failure as determined by need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/or ECMO until end of study (measured at 8 weeks)
    • All cause mortality by end of study (measured at 4 and 8 weeks)
    • Reduction in severe respiratory failure rate as defined by the need for high-flow oxygen use and/or invasive/non invasive ventilation techniques and/or ECMO at 4 weeks and end of study (8 weeks)
    • Safety and tolerability of pamapimod used in combination with pioglitazone
    • Length of hospitalization
    • Length of ICU stay
    • Days free of invasive mechanical ventilation at 4 and 8 weeks
    • Total days free of any oxygen supplementation at 4 and 8 weeks
    • Clinical Status on Baseline, days 4, 7 and 14 and week 4 and 8 measured by the nine point WHO COVID-19 clinical progression score and EQ5D
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks / 4 weeks
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Switzerland
    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
    Trial end is defined as last visit of the last subject LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 288
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For patients unable to understand and sign themselves, his/her legal representative will be informed and signs the informed consent document in countries where this is possible per national laws and regulations.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 432
    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)
    After completion of the clinical trial for the individual patient, treatment will revert to the 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 Decision2021-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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