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    Summary
    EudraCT Number:2020-003278-37
    Sponsor's Protocol Code Number:INSIGHT014
    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:2020-08-14
    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 number2020-003278-37
    A.3Full title of the trial
    A Multicentre, Adaptive, Randomised, Blinded Controlled Trial
    of the Safety and Efficacy of Investigational Therapeutics
    for Hospitalised Patients with COVID-19

    Short Title: Therapeutics for Inpatients with COVID-19 (TICO)

    INSIGHT Protocol Number: 014 / ACTIV-3
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapeutics for Inpatients with COVID-19 (TICO)
    A.3.2Name or abbreviated title of the trial where available
    Therapeutics for Inpatients with COVID-19 (TICO)
    A.4.1Sponsor's protocol code numberINSIGHT014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04501978
    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 SponsorReagents of the University of Minnesota
    B.1.3.4CountryUnited States
    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 organisationMRC CTU at UCL
    B.5.2Functional name of contact pointSarah Pett
    B.5.3 Address:
    B.5.3.1Street Address90 High Holborn
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1V 6LJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02076704700
    B.5.5Fax number02076704818
    B.5.6E-mails.pett@ucl.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 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 nameLY3819253
    D.3.2Product code SUB127300
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLY3819253
    D.3.9.4EV Substance CodeAS2
    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 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 Yes
    D.3.11.13.1Other medicinal product typeSynthetically made product, modelled from a human antibody
    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 Remdesivir
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRemdesivir
    D.3.2Product code SUB195655
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRemdesivir (active drug Triphosphate)
    D.3.9.1CAS number 1809249-37-3
    D.3.9.2Current sponsor codeGS-5734
    D.3.9.3Other descriptive nameN/A
    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 numberConc nos=5mg/mL
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    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
    The primary endpoint of TICO is to test whether the nMAb(s) result in more people with ‘sustained’ recovery i.e. discharged from hospital, alive, and home for 14 consecutive days by Day 90.
    E.2.2Secondary objectives of the trial
    1) For everyone enrolled during stage 1 and 2 of the trial the secondary research questions are to define, the numbers of deaths through 90 days of follow-up; the number of people who experience sustained recovery over 90 days, the time to discharge from the initial hospital, and the number of days alive up to day 90.

    2) Changes in the scores to assess people’s lung and respiratory function on Days 1-7, and Days 14 and 28.

    3) Changes between Day 0 and Day 5 in the National Early Warning (NEW) score, this is a scoring system validated in the UK, which is able to score how sick people are, and their risk of dying, based on things like their blood pressure, pulse rate and body temperature.

    4) Clinical organ failure defined by development of any one or more of the following through Day 28

    a. Respiratory system dysfunction including the need for oxygen therapy or ventilation
    b. Cardiac problems include heart attacks and heart failure
    c. Low blood pressure requiring drug support to mai
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    INSIGHT Genomics Study (Protocol No. 004 version 2.0, dated 27 August 2013)
    The purposed of this study is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other genetic variants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.
    E.3Principal inclusion criteria
    1. Age ≥ 18 years;

    2. Informed consent by the patient or the patient’s legally-authorized representative (LAR)*

    3. SARS-CoV-2 infection, documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator;

    4. Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator;

    5. Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.

    *Continuing consent
    Participants for whom consent was initially obtained from a LAR, but who subsequently regain decision-making capacity while in hospital will be approached for consent for continuing participation, including continuance of data collection.
    E.4Principal exclusion criteria
    1. Prior receipt of any SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19 or any SARS-CoV-2 nMAb at any time prior to hospitalization;

    2. Not willing to abstain from participation in other COVID-19 treatment trials until after Day 5;

    3. In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments;

    4. Expected inability to participate in study procedures;

    5. Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through Day 90 of the study.

    6. Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or who are unwilling to use barrier contraception through Day 90 of the study.

    7. stage 1 only]
    Presence at enrollment of any of the following:
    a. stroke
    b. meningitis
    c. encephalitis
    d. myelitis
    e. myocardial infarction
    f. myocarditis
    g. pericarditis
    h. symptomatic congestive heart failure (NYHA class III-IV)
    i. arterial or deep venous thrombosis or pulmonary embolism

    8. stage 1 only
    Current or imminent requirement for any of the following:
    a. invasive mechanical ventilation
    b. ECMO
    c. mechanical circulatory support
    d. vasopressor therapy
    e. commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).



    E.5 End points
    E.5.1Primary end point(s)
    Stage 1 Outcomes to Evaluate Activity
    Two intermediate, ordinal categorical outcomes assessed at Day 5 are used to evaluate potential activity.
    are used in stage 1. Both are ordinal categorical outcomes assessed 5 days after randomisation (Day 5); the participant’s highest (i.e. most severe) observed score on Day 5 is used.
    A)“pulmonary” ordinal outcome, (7 categories) are primarily defined based on oxygen requirements.
    1.Can independently undertake usual activities with minimal or no symptoms
    2.Symptomatic and currently unable to independently undertake usual activities but no need of supplemental oxygen (or not above premorbid requirements)
    3.Supplemental oxygen (<4 litres/min, or <4 litres/min above premorbid requirements)
    4.Supplemental oxygen (≥4 litres/min, or ≥4 litres/min above premorbid requirements, but not high-flow oxygen)
    5.Non-invasive ventilation or high-flow oxygen
    6.Invasive ventilation, extracorporeal membrane oxygenation (ECMO), mechanical circulatory support, or new receipt of renal replacement therapy
    7.Death

    B)“pulmonary+, ordinal outcome ( 7 categories), captures extrapulmonary complications as well as respiratory dysfunction.
    1.Can independently undertake usual activities with minimal or no symptoms
    2.Symptomatic and currently unable to independently undertake usual activities but no need of supplemental oxygen (or not above premorbid requirements)
    3.Supplemental oxygen (<4 litres/min, or <4 litres/min above premorbid requirements)
    4.Supplemental oxygen (≥4 litres/min, or ≥4 litres/min above premorbid requirements, but not high-flow oxygen) or any of the following: stroke (NIH Stroke Scale [NIHSS] ≤14), meningitis, encephalitis, myelitis, myocardial infarction, myocarditis, pericarditis, new onset CHF NYHA class III or IV or worsening to class III or IV, arterial or deep venous thromboembolic events.
    5.Non-invasive ventilation or high-flow oxygen, or signs and symptoms of an acute stroke (NIHSS >14)
    6.Invasive ventilation, ECMO or mechanical circulatory support; vasopressor therapy; or new receipt of renal replacement therapy
    7.Death

    Stage 2 Outcomes to Evaluate Efficacy and Safety
    The primary endpoint is time from randomisation to sustained recovery, defined as being discharged from the index hospitalisation, followed by being alive and home for 14 consecutive days prior to Day 90.
    Home is defined as the level of residence or facility where the participant was residing prior to hospital admission leading to enrolment in this protocol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage 1
    Two intermediate outcomes to evaluate potential activity are used in
    stage 1. Both are ordinal categorical outcomes assessed 5 days after
    randomisation (Day 5); the participant's highest (i.e. most severe)
    observed score on Day 5 is used.
    Stage 2
    The primary outcome is assessed during 90 days of follow-up, which is
    longer than for other trials for COVID-19, which are typically 28 days.
    The longer follow-up will allow better ascertainment of recovery from
    the longer-term consequences of the underlying disease, and hence the
    efficacy of the investigational agent. This is likely to be particularly true
    for patients who experience extra-pulmonary disease in conjunction with
    their COVID-19, and for patients enrolled while receiving care for life threatening
    organ failure.
    E.5.2Secondary end point(s)
    Several secondary efficacy endpoints will be assessed. These endpoints
    will be assessed for participants enrolled during both stages of the trial.
    1. All-cause mortality through 90 days of follow-up
    2. Composite of time to sustained recovery and mortality through 90
    days of follow-up
    3. Time to discharge for the initial hospitalisation
    4. Days alive outside of a short-term acute care hospital up to day 90
    5. Ordinal outcomes, pulmonary+ and pulmonary, on Days 1-7, and
    pulmonary ordinal outcome on Days 14 and 28
    6. Change in National Early Warning (NEW) score from baseline to Day 5
    7. Clinical organ failure defined by development of any one or more of
    the following clinical events through Day 28:
    a. Respiratory dysfunction:
    b. Cardiac and vascular dysfunction:
    c. Renal dysfunction:
    d. Hepatic dysfunction:
    e. Neurological dysfunction
    f. Haematological dysfunction
    g. Serious infection:
    8. A composite of death or clinical organ failure COVID-19-related events (see above)
    9. Outcomes assessed in other treatment trials of COVID-19 for
    hospitalised participants in order to facilitate cross-trial comparisons
    and overviews (e.g. 6- , 7-, and 8-category ordinal scales assessed at
    Days 1-7, 14 and 28; time to improvement in 1 or 2 categories of ordinal
    scale; time to best 3 categories of ordinal scale, and binary outcomes
    defined by improvement or worsening based on other ordinal outcomes)
    10. A composite of cardiovascular events (outcomes listed above in
    items 7)
    11. Safety and tolerability as measured by:
    a. A composite of grade 3 and 4 clinical adverse events, SAEs, or death
    through Day 5 (primary safety endpoint) and through Day 28
    b. Infusion-related reactions of any severity and percentage of
    participants for whom the infusion was interrupted or stopped prior to
    completion
    c. A composite of SAEs or death through Day 90
    d. Adverse events of any grade through Day 7
    e. Prevalence of adverse events of any grade at day 14 and day 28
    12. Change in antibody profile, overall titres of antibodies and
    neutralising antibody levels from baseline to Days 1, 3, 5 and 28 and 90
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for the measurements are described in connection with the
    individual secondary endpoints.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Adaptive
    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 concerned7
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Argentina
    Australia
    Belgium
    Brazil
    Denmark
    France
    Georgia
    Germany
    Greece
    Ireland
    Italy
    Mexico
    Peru
    Poland
    Portugal
    Singapore
    Spain
    Sweden
    Switzerland
    Uganda
    United Kingdom
    United States
    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 months0
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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
    Hospitalised inpatients who are incapacitated according to local standards and policies
    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 200
    F.4.2.2In the whole clinical trial 1000
    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 experimental treatment given to subjects is a one off infusion of monoclonal antibodies. Subjects will also receive up to 10 infusions of Remdesivir as part of standard of care. The subject's participation in the trial will end on Day 90 and there are no arrangements for participants to receive any trial treatment afterwards. Patients will continue under the appropriate medical care, as required.
    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 Medical Research Council Clinical Trials Unit at University College London
    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 Decision2020-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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