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    Summary
    EudraCT Number:2020-001636-95
    Sponsor's Protocol Code Number:282110
    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:2020-05-04
    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 number2020-001636-95
    A.3Full title of the trial
    Subcutaneous and Intravenous anakinra in COVID-19 Infection - Feasibility & Pharmacokinetics/ Pharmacodynamics study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does subcutaneously(SC) administered of anakinra achieve good penetration in blood and result in reduce inflammation in patients with SARS-CoV-19?
    A.3.2Name or abbreviated title of the trial where available
    SCIL-COV19 PK/PD trial
    A.4.1Sponsor's protocol code number282110
    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 SponsorUniversity of Manchester
    B.1.3.4Country
    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 organisationManchester University NHS Foundation Trust
    B.5.2Functional name of contact pointTim Felton
    B.5.3 Address:
    B.5.3.1Street AddressAcademic Hub, 2nd Floor, ERC
    B.5.3.2Town/ cityWythenshaw Hospital, Manchester
    B.5.3.3Post codeM23 9PL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0) 161 275 1682
    B.5.6E-mailtim.felton@manchester.ac.uk
    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 Anakinra
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum Ab, Sweden
    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 nameAnakinra
    D.3.2Product code L04AA14
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnakinra
    D.3.9.1CAS number 143090920
    D.3.9.2Current sponsor code282110
    D.3.9.3Other descriptive nameKineret
    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
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Suspected or confirmed SARS-CoV-2 infection (confirmed by RNA-PCR)
    E.1.1.1Medical condition in easily understood language
    SARS-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 PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Principal question/objective:

    Ascertain if anakinra administered subcutaneously will reach concentrations in the plasma (blood) that is thought to be effective and ascertain its effect on inflammation within the first week of treatment with the drug.

    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    1. To establish a relationship between concentrations of anakinra and markers of inflammation after SC and IV administration.
    2. To determine and compare the pharmacokinetics and pharmacodynamics (amount and action of drug within the body) of SC and IV anakinra.
    3. Obtain further safety information on patients with SARS-CoV-2 given SC anakinra.
    4. To obtain and compare the feasibility of SC and IV administration.
    5. To obtain preliminary data on efficacy and help to decide if a larger study of SC anakinra in COVID-19 patients is justified.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient age 18 or above.
    • Clinically suspected/proven COVID-19.
    • Requiring organ support with one or more of:
    o Non-invasive or invasive ventilatory support
    o Receiving infusion of vasopressor or inotropes or both.
    • No concomitant health problems that, in the opinion of the PI or designee in agreement with the treating clinician, would interfere with participation, administration of study drug or assessment of outcomes including safety.
    E.4Principal exclusion criteria
    • More than 24h has elapsed since CCU admission.
    • Death is deemed to be imminent and inevitable during the next 24h.
    • One or more of: the patient, personal/ professional legal representative or the attending physician are not committed to full active treatment.
    • Known condition resulting in ongoing immunosuppression including neutropenia (count < 1.5 x 109/L) prior to hospitalisation, malignancy, latent tuberculosis or chronic liver disease (if known).
    • Previous or current treatment with anakinra or medication suspected of interacting with anakinra, listed in the drug SmPC, known at the time of trial entry or previous participation in this trial.
    • Known to have received active treatment in a clinical trial of an investigational immunomodulatory agent (not including corticosteroids) within 30 days prior to study entry.
    • Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant.
    • Known allergy to anakinra or any of the excipients listed in the drug SmPC.
    • Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. Escherichia coli derived protein).
    E.5 End points
    E.5.1Primary end point(s)
    Plasma IL-1Ra levels from Day 1 to Day 7 following administration of SC anakinra in patients with SARS-CoV-2 infection.

    Plasma IL-6 levels from Day 1 to Day 7 following administration of SC anakinra in patients with SARS-CoV-2 infection.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Sampling at baseline, days 1, 3, 5, 7 and end of administration (day 14 or earlier) post-randomisation.



    E.5.2Secondary end point(s)
    1. Change from baseline with measurements performed every 3 days for markers including the following: IL-6, CRP, CXCL2, IL-1, IL-6 , IL-2, HMBG-1 and IL-33.

    2. Safety endpoints include
    a) severe fatal or life-threatening serious adverse reactions (duration of IMP plus 30h from last dose).
    b) anaphylactic/anaphylactoid reactions (duration of IMP plus 30h from last dose).
    c) severe neutropenia (< 1.5 x 10^9 /L) (duration of IMP)
    d) IMP related severe laboratory abnormalities (duration of IMP)

    3. Feasibility endpoints include protocol deviations in terms of timing and delivery of schedule medication.

    4. Exploratory data on clinical efficacy as defined by:
    a) Time to recovery defined by hospital discharge or improvement of two points on the ordinal scale: not hospitalised; hospitalised without need for supplemental oxygen; requiring supplemental oxygen; requiring HFNC or non-invasive mechanical ventilation; requiring ECMO or mechanical intervention; dead. Improvement mechanical ventilation (from recruitment to time of ventilation).
    b) Ventilation free days (at 28 days).
    c) Status on the above ordinal scale (at 14 and 28 days).
    E.5.2.1Timepoint(s) of evaluation of this end point
    All endpoints will be evaluated up to day 14 unless otherwise specified above.
    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 No
    E.6.5Efficacy No
    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) 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    same IMP different route of administration
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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
    last patient, last visit
    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 months3
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days27
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients on Critical Care with COVID-19 infection
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    The aim of this trial is pharmacokinetic and pharmacodynamics. There is no therapeutic benefit promised at this stage and there is no requirement for continuation of the trial drug after the end of planned dosing regimen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Trials Unit, University of Manchester
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-20
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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