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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2020-001750-22
    Sponsor's Protocol Code Number:20HH5926
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-07-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-001750-22
    A.3Full title of the trial
    MATIS: Phase 2/3, Randomised, Open-Label, Single-Site, Multi-Arm Trial of Ruxolitinib Plus Best Supportive Treatment (BST) versus Fostamatinib Plus BST versus BST for COVID-19 pneumonia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS)
    A.3.2Name or abbreviated title of the trial where available
    Multi-arm trial of Inflammatory Signal Inhibitors for COVID-19 (MATIS)
    A.4.1Sponsor's protocol code number20HH5926
    A.5.4Other Identifiers
    Name:Sponsor Protocol NumberNumber:20HH5926
    Name:European Clinical Trials Database (EudraCT) numberNumber:2020-001750-22
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJoint Research Compliance Office
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College Healthcare NHS Trust
    B.5.2Functional name of contact pointTina Shturova-Chakreska
    B.5.3 Address:
    B.5.3.1Street AddressDu Cane Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 0HS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0203 704 8215
    B.5.5Fax number0208 383 8575
    B.5.6E-mailt.shturova@nhs.net
    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 Yes
    D.2.1.1.1Trade name Tavlesse®
    D.2.1.1.2Name of the Marketing Authorisation holderRigel Pharmaceuticals B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTavlesse®
    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 INNfostamatinib disodium hexahydrate
    D.3.9.3Other descriptive namefostamatinib
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 to 150
    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 Yes
    D.2.1.1.1Trade name Jakavi®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameJakavi®
    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 INNRuxolitinib
    D.3.9.3Other descriptive nameINCB018424 phosphate, INC424, ruxolitinib phosphate
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to 10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 pneumonia
    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
    • Determine the efficacy of RUX and FOS to reduce the proportion of hospitalised patients progressing from mild to severe COVID-19 pneumonia
    E.2.2Secondary objectives of the trial
    1. Determine the efficacy of RUX or FOS to reduce mortality
    2. Determine the efficacy of RUX or FOS to reduce the need for invasive ventilation or ECMO
    3. Determine the efficacy of RUX or FOS to reduce the need for non-invasive ventilation
    4. Determine the efficacy of RUX or FOS to reduce the proportion of patients suffering significant oxygen desaturation
    5. Determine the efficacy of RUX or FOS to reduce the need for renal replacement therapy
    6. Determine the efficacy of RUX and FOS to reduce the severity on COVID19 pneumonia [graded by a modified WHO Ordinal Scale]
    7. Determine the efficacy of RUX or FOS to reduce the level of inflammatory biomarkers
    8. Determine the efficacy of RUX or FOS to reduce duration of hospital admission
    9. Evaluate the safety of RUX and FOS for COVID19 pneumonia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients age ≥ 18 years at screening

    2. Hospitalisation with COVID-19 pneumonia AND
    - SARS-CoV2 infection (clinically suspected OR laboratory confirmed) AND
    - Radiological change consistent with COVID-19 disease

    3. Grade 3 or 4 severity (WHO COVID-19 Ordinal Scale)

    4. C-reactive protein (CRP) ≥50mg/L

    5. Informed consent from patient or professional representative

    6. No medical history that might, in the opinion of the responsible clinician, put the patient at significant risk if he/she were to participate in the trial

    7. Agreement to abstain from sexual intercourse or use contraception that is >99% effective for all participants of childbearing potential for 42 days

    8. For male participants, agreement to abstain from sperm donation for 42 days

    9. Non-English speakers will be able to join the study. If patients are unable to understand verbal or written information in English - hospital translation services will be requested at the participating site for the participant where possible.
    E.4Principal exclusion criteria
    1. Requiring either invasive or non-invasive ventilation including continuous positive airway pressure (CPAP) or high flow nasal oxygen at any point before baseline

    2. Grade ≥5 severity on the WHO COVID-19 Ordinal Scale

    3. O2 saturation < 90% on ≥60% inspired oxygen at baseline

    4. In the opinion of the investigator, progression to death is inevitable within the next 24 hours, irrespective of the provision of therapy

    5. Known severe allergic reactions to the investigational agents

    6. Use of drugs within the preceding 14 days that are known to interact with any study treatment

    7. Child Pugh B or C grade hepatic dysfunction

    8. End stage renal failure (ESRF)

    9. Pregnant or breast feeding

    10. Participation in other clinical trials
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is progression from mild to severe COVID-19 pneumonia within 14 days in hospitalised patients. Patients are recruited at a WHO COVID-19 Severity Score of 3 and 4 and the primary endpoint is the comparison of patients whose COVID-19 pneumonia progresses to a severity score  5 on the modified WHO Ordinal Scale. Specifically, the primary endpoint is met when the following are recorded within 14 days:

    - Death

    - Requirement for invasive ventilation

    - Requirement for non-invasive ventilation including CPAP

    - O2 saturation < 90% on ≥60% inspired oxygen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14.
    E.5.2Secondary end point(s)
    1. Determine the efficacy of ruxolitinib or fostamatinib to reduce mortality

    2. Determine the efficacy of ruxolitinib or fostamatinib to reduce the need for invasive ventilation and/or extra corporeal membrane oxygenation (ECMO)

    3. Determine the efficacy of ruxolitinib or fostamatinib to reduce the need for non-invasive ventilation including continuous positive airway pressure (CPAP) or high flow nasal oxygen

    4. Determine the efficacy of ruxolitinib or fostamatinib to reduce the proportion of patients suffering clinically significant oxygen desaturation

    5. Determine the efficacy of ruxolitinib or fostamatinib to reduce the need for renal replacement therapy

    6. Determine the efficacy of ruxolitinib or fostamatinib to improve the severity of COVID-19 pneumonia on a modified WHO COVID-19 Ordinal Scale

    7. Determine the efficacy of ruxolitinib or fostamatinib to reduce blood ferritin, CRP, LDH and D-dimer

    8. Determine the efficacy of ruxolitinib or fostamatinib to reduce duration of hospital admission

    9. Evaluate the safety of ruxolitinib and fostamatinib for COVID-19 pneumonia
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 14 and 28.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    The end of the scheduled treatment phase is defined as the date of the last Follow-up visit of the last participant. The end of the study is the date of the final data extraction from NHS Digital (anticipated to be 10 years after the last patient is enrolled).
    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 months7
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 state186
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 186
    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)
    Once they have completed the study, the study doctor will advise participants what standard of care or other treatment is available to them.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-26
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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