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    Summary
    EudraCT Number:2020-002542-16
    Sponsor's Protocol Code Number:INSIGHT013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-17
    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 number2020-002542-16
    A.3Full title of the trial
    An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)
    A.3.2Name or abbreviated title of the trial where available
    Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)
    A.4.1Sponsor's protocol code numberINSIGHT013
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04546581
    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 SponsorOffice of Sponsored Projects, Regents 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 nameAnti-COVID-19 Hyperimmune Globulin (Human) - Grifols Therapeutics LLC
    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 INNAnti-COVID-19 Hyperimmune Globulin (Human)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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.3.1Product nameAnti-COVID-19 hyperimmune globulin (human) - Takeda Pharmaceuticals
    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 INNAnti-COVID-19 hyperimmune globulin (human)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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: 3
    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 nameAnti-COVID-19 hyperimmune globulin (human) - Emergent Biosolutions
    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 INNAnti-COVID-19 hyperimmune globulin (human) - Emergent Biosolutions
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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: 4
    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 nameAnti-COVID-19 hyperimmune globulin (human) - CSL Behring AG
    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 INNAnti-COVID-19 hyperimmune globulin (human) - CSL Behring AG
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    COVID-19 (SARS-CoV-2) infection
    E.1.1.1Medical condition in easily understood language
    Coronavirus infection (a respiratory disease caused by a novel coronavirus)
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    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 this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications:

    7. Death
    6. End-organ failure
    5. Life-threatening end-organ dysfunction
    4. Serious end-organ dysfunction
    3. Moderate end-organ dysfunction
    2. Limiting symptoms due to COVID-19
    1. No limiting symptoms due to COVID-19

    The rationale behind this approach is to estimate in a clinically meaningful way whether the study drug has had a favourable clinical impact on the patient.
    E.2.2Secondary objectives of the trial
    1. All-cause mortality through Day 28.

    2. The primary ordinal outcome on Days 3, 5, 14 and 28.

    3. Change in National Early Warning Score (NEWS) from baseline at Day 3. 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. Time to the 3 least favourable categories of the primary outcome measure

    5. Time to the 2 most favourable categories of the primary outcome measure.

    6. Hospitalization status (alive and discharged from the hospital to home or rehabilitation, versus dead or hospitalized) at Days 7, 14 and 28.

    7. Time to discharge.

    8. Days alive outside of a hospital through Day 28.

    9. Pulmonary only components of the primary outcome measure at Days 3, 5, 7, 14 and 28

    10. Thrombotic components of the primary outcome measure (stroke, myocardial infarction, venous and arterial thrombosis or embolism, plus disseminated intravascular
    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 (INSIGHT Protocol No. 004 version 2.0, dated 27 August 2013).
    The purpose 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
    In order to be eligible to participate in this study, a participant must meet all of the following criteria:

    1. 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.

    2. Symptomatic COVID-19 disease

    3. Duration of symptoms attributable to COVID-19 ≤ 12 days

    4. Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)

    5. Age ≥ 18 years

    6. Willingness to abstain from participation in other COVID-19 treatment trials until after study day 7

    7. Provision of informed consent by participant or legally authorized representative
    E.4Principal exclusion criteria
    1. Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time

    2. Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days

    3. Current or predicted imminent (within 24 hours) requirement for any of the following:
    • Invasive ventilation
    • Non-invasive ventilation
    • Extracorporeal membrane oxygenation
    • Mechanical circulatory support
    • Continuous vasopressor therapy

    4. History of allergy to IVIG or plasma products

    5. History of selective IgA deficiency with documented presence of anti-IgA antibodies

    6. Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient
    • Includes New York Heart Association Class III or IV stage heart failure

    7. Any of the following thrombotic or procoagulant disorders:
    • Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of randomization
    • History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome

    8. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

    9. Prior participation in a COVID-19 treatment trial within 6 months of enrolment
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. Categories are:
    7. Death
    6. End-organ failure
    5. Life-threatening end-organ dysfunction
    4. Serious end-organ dysfunction
    3. Moderate end-organ dysfunction
    2. Limiting symptoms due to COVID-19
    1. No limiting symptoms due to COVID-19
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical status on Day 7
    E.5.2Secondary end point(s)
    1. All-cause mortality through Day 28.

    2. The primary ordinal outcome on Days 3, 5, 14 and 28.

    3. Change in National Early Warning Score (NEWS) from baseline at Day 3. 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. Time to the 3 least favourable categories of the primary outcome measure

    5. Time to the 2 most favourable categories of the primary outcome measure.

    6. Hospitalization status (alive and discharged from the hospital to home or rehabilitation, versus dead or hospitalized) at Days 7, 14 and 28.

    7. Time to discharge.

    8. Days alive outside of a hospital through Day 28.

    9. Pulmonary only components of the primary outcome measure at Days 3, 5, 7, 14 and 28

    10. Thrombotic components of the primary outcome measure (stroke, myocardial infarction, venous and arterial thrombosis or embolism, plus disseminated intravascular coagulation) at Days 3, 5, 7, 14, and 28.

    11. Outcomes assessed in other treatment trials of COVID-19 for hospitalized participants in order to facilitate cross trial comparisons and overviews, e.g., 6-, 7- and 8- category ordinal scales at days 7, 14 and 28; and binary outcomes defined by improvement or worsening based on the primary ordinal outcome and ordinal outcomes used in other trials.

    12. Clinical organ dysfunction defined by new onset of any one or more of the following conditions (or requirement for the following therapies) through Day 28:
    a. Respiratory:
    1. Extracorporeal membrane oxygenation (ECMO)
    2. Invasive ventilation
    3. Non-invasive ventilation or high flow oxygen
    b. Cardiac and vascular:
    1. Myocardial infarction
    2. Myocarditis or pericarditis
    3. NYHA Class III/IV congestive cardiac failure
    4. Vasopressor therapy
    c. Renal:
    1. Renal replacement therapy (dialysis)
    d. Hepatic:
    1. Hepatic decompensation
    e. Neurological
    1. Cerebrovascular event (stroke)
    2. Encephalitis, meningitis or myelitis
    3. Acute delirium
    f. Hematological:
    1. Disseminated intravascular coagulation
    2. New thrombotic events, including pulmonary embolism, deep venous thrombosis, or arterial thrombosis
    g. Infective:
    1. Microbiologically-proven severe infection (not including SARS-CoV-2)

    13. Safety and tolerability will be assessed using outcomes described above and also assessed by the following outcomes:
    a. A composite of incident grade 3 and 4 events (not limited to a laboratory abnormality), SAEs (see Section10.1.2), or death through Day 7 (primary safety endpoint)
    b. Infusion reactions of any grade severity during the infusion and 2 hours post-infusion, and percentage of participants for whom the infusion was interrupted or stopped prior to completion
    c. SAEs or deaths through Day 28
    d. Prevalence of adverse events of any grade on Days 1, 3, 7 and 28.

    14. Change in immunoglobulin levels (IgG, IgG subclasses, IgM, IgA) and neutralizing antibody titers from baseline to Days 1, 2, 3, 7, 28 and 90.

    15. The primary endpoint by duration of symptoms at study entry.

    16. The primary endpoint for other subgroups defined by the characteristics measured at baseline will also be assessed:
    • Age
    • Biological sex
    • Race/ethnicity
    • BMI
    • Presence of selected chronic medical conditions (cardiovascular disease, diabetes, asthma, chronic obstructive pulmonary disease, hypertension, cancer)
    • Geographic location
    • hIVIG product administered
    • hIVIG lot potency of administered product
    • Upper respiratory SARS-CoV-2 viral load
    • Neutralizing antibody level
    • Oxygen saturation level
    • Dyspnea severity
    • Organ/respiratory dysfunction category based on ordinal primary outcome
    • NEWS
    • Disease progression risk score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for the measurements are described in connection with the individual secondary endpoints in section 23-2.
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    Denmark
    France
    Germany
    Greece
    Israel
    Japan
    Mexico
    Nigeria
    Peru
    Poland
    Portugal
    Spain
    Thailand
    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. However, the analysis of the stored samples for antibody levels will occur after the LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days31
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-09-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 500
    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 hIVIG. Subjects will also receive up to 10 infusions of Remdesivir as part of standard of care. There are no arrangements for the participants to receive the trial treatment after follow-up of the study is complete (Day 90 for UK sites). Patients will continue to be under the medical care of their local physician/hospital.
    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 MRC Clinical Trials Unit at UCL
    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 Decision2020-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-22
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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