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    The EU Clinical Trials Register currently displays   44195   clinical trials with a EudraCT protocol, of which   7329   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).

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    Summary
    EudraCT Number:2020-002542-16
    Sponsor's Protocol Code Number:INSIGHT-013-ITAC
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-10
    Trial results View 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 ConcernedDenmark - DHMA
    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
    Same as above
    A.3.2Name or abbreviated title of the trial where available
    Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)
    A.4.1Sponsor's protocol code numberINSIGHT-013-ITAC
    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 SponsorRegents 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 supportUniversity of Minnesota
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHIP, Rigshospitalet, University of Copenhagen
    B.5.2Functional name of contact pointJens Lundgren
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number+453545 5757
    B.5.5Fax number+453545 5758
    B.5.6E-mailjens.lundgren@regionh.dk
    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.3.2Product code Anti-COVID-19 Hyperimmune Globulin (Human)
    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 INNNP-028 Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human)
    D.3.9.1CAS number 308067-58-5
    D.3.9.3Other descriptive nameHUMAN IMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB127300
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number85 to 115
    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 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 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
    Subjects infected with SARS-CoV-2, admitted to hospital due to COVID-19
    E.1.1.1Medical condition in easily understood language
    Infection with Coronavirus SARS-CoV-2/COVID-19 that leads to hospitalisation
    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 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 compare the clinical status of participants in the hIVIG + SOC and placebo + SOC groups on Day 7 using an ordinal outcome with 7 mutually exclusive categories. On Day 7, the worst of the 7 categories the participant was in that day will constitute the primary outcome. The 7 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
    Appendix F in the protocol provides clinical definitions of each category. In addition to the overall summary odds ratio (OR) that will be estimated as described in Section 11.1, ORs will be estimated for the 6 dichotomized definitions of improvement that can be formulated from the categories of the ordinal outcome.
    E.2.2Secondary objectives of the trial
    Secondary objectives will be assessed by comparing hIVIG + SOC with placebo + SOC over the 28 day follow-up period for outcomes listed below.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion 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:
    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
    E.5 End points
    E.5.1Primary end point(s)
    The goals of this study are to assess the safety, tolerability and efficacy of a single infusion of hIVIG in preventing further progression and mortality related to COVID-19 when administered at the onset of clinical progression, with the aim of improving the long term outcome of the disease process. There is as yet no consensus on the optimal endpoint for determining clinical benefit from COVID-19 therapies, including the constituent elements of the endpoint and the timing of its assessment after randomization. Both may differ depending on the target population and the nature of the treatment studied.
    The primary ordinal outcome captures the range of severity experienced by hospitalized patients with COVID 19, recognizing that end-organ manifestations in addition to pneumonia and ARDS are increasingly emerging as significant contributors to morbidity. The ordinal outcome includes 7 well-defined mutually exclusive categories that assess further progression of disease as well as recovery from COVID-19.
    The ordinal outcome includes both pulmonary manifestations as assessed in prior COVID-19 trials and additional components representing key non-pulmonary outcomes; the latter are highlighted as “extra-pulmonary” in the guidance table (Appendix F). The primary endpoint will include both pulmonary and extra-pulmonary components, while the pulmonary manifestation scale only will be reported as a secondary endpoint.
    Day 7 was chosen for the timing of the primary endpoint for several reasons based on the following assumptions. The impact of hIVIG on disease progression may not be immediate; a few days may be needed to see the effects on clinical outcomes as measured by the ordinal outcome. Also, transient treatment effects that are no longer present at Day 7 may be clinically less relevant. Assessment of the ordinal outcome at a later time point may result in a diminished treatment difference because spontaneous recovery from COVID-19 may have begun in many participants. Also, antibody differences between the treatment groups, an important biologic mechanism for observing a clinical benefit, are assumed to be greatest during the first week after infusion.
    Lastly, use of Day 7 to characterize the clinical severity of participants in 7 categories as studied here, results in a distribution of participants in the placebo group for the ordinal outcome that is sufficiently granular and not overly skewed to the most severe or least severe categories and, therefore, provides good power for comparing the two treatment groups with a feasible sample size given the difficulty in producing large quantities of hIVIG (see Section 5.5).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7 was chosen for the timing of the primary endpoint for several reasons based on the following assumptions. The impact of hIVIG on disease progression may not be immediate; a few days may be needed to see the effects on clinical outcomes as measured by the ordinal outcome. Also, transient treatment effects that are no longer present at Day 7 may be clinically less relevant.
    E.5.2Secondary end point(s)
    Secondary objectives will be assessed by comparing hIVIG + SOC with placebo + SOC over the 28 day follow-up period for outcomes listed in the protocol page 25. Because there is no established endpoint for evaluating the clinical efficacy of treatments for COVID-19, other clinically relevant outcomes, including outcomes used in other COVID-19 treatment trials, will be recorded. Thus, the randomized groups can be compared for multiple outcomes, and results can be compared or combined with other trials. Many of the endpoints used in other trials are ordinal outcomes or are defined based on a dichotomy of an ordinal outcome and assessed at a single follow-up time point or as a time-to-event outcome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 28 day follow-up period.
    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 concerned10
    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
    Denmark
    France
    Germany
    Greece
    Israel
    Japan
    Mexico
    Nigeria
    Peru
    Spain
    Thailand
    United Kingdom
    United States
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 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 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
    Informed consent given by the patient's leally-authorised representative will be used in contries where this is allowed. Participants who subsequently regain decision-making capacity will be asked to give consent for continuing participation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    None
    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 INSIGHT (International Network for Strategic Initiatives in Global HIV Trials)
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-21
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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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