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    Summary
    EudraCT Number:2020-005410-18
    Sponsor's Protocol Code Number:2020/ABM/COVID19/0036
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-16
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005410-18
    A.3Full title of the trial
    Multicentre, randomized, double-blind, placebo-controlled, non-commercial clinical trial to evaluate the efficacy and safety of specific anti-SARS-CoV-2 immunoglobulin in the treatment of COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre, randomized, double-blind, placebo-controlled, non-commercial clinical trial to evaluate the efficacy and safety of specific anti-SARS-CoV-2 immunoglobulin in the treatment of COVID-19
    A.4.1Sponsor's protocol code number2020/ABM/COVID19/0036
    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 SponsorSamodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zakład Opieki Zdrowotnej
    B.1.3.4CountryPoland
    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 supportSamodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zakład Opieki Zdrowotnej
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSamodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie Samodzielny Publiczny Zakład Opieki Zdrowotnej
    B.5.2Functional name of contact pointKrzysztof Tomasiewicz
    B.5.3 Address:
    B.5.3.1Street Addressul. Stanisława Staszica 16
    B.5.3.2Town/ cityLublin
    B.5.3.3Post code20-081
    B.5.3.4CountryPoland
    B.5.4Telephone number00488153 49 414564
    B.5.5Fax number00488153 49 410
    B.5.6E-mailkrzysztoftomasiewicz@umlub.pl
    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 SARS-CoV-2 immunoglobulin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAnti-SARS-CoV-2 immunoglobulin
    D.3.9.3Other descriptive nameHUMAN IMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB127300
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CoronaVirus Disease 2019
    E.1.1.1Medical condition in easily understood language
    CoronaVirus Disease 2019
    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
    To evaluate the safety and efficacy of specific anti-SARS-CoV-2 immunoglobulin used in a hospital conditions (administered in the form of intramuscular injection) along with standard symptomatic treatment in accordance with the guidelines of PTEiLChZ in patients with SARS-CoV-2 infection.

    No need for supplementation with oxygen on day 7 and 14.
    E.2.2Secondary objectives of the trial
    Safety-related endpoints:
    1. Occurrence of serious adverse events up to day 28 from the start of study therapy

    Effectiveness-related endpoints:
    1. The need for mechanical ventilation in the patient
    2. Time of using oxygen therapy
    3. The need to use tocilizumab or other anti-cytokine drugs
    4. Time to discharge from hospital
    5. Time to negative PCR test for SARS-CoV-2 virus RNA
    6. Occurrence of any COVID-19 related symptoms on day 28
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age over 18 years
    2. Sign informed consent in order to participate in the study
    3. SARS-CoV-2 infection (positive RT-PCR test for SARS-CoV-2)
    4. Indication for hospitalization due to the course of COVID-19
    5. The patient's clinical condition is assessed at 3-5 on the ORDINAL scale:
    • 3 - Hospitalization without oxygen therapy
    • 4 - Hospitalization with low flow oxygen support on a nasal mask or mustache
    • 5 - hospitalization with high flow oxygen therapy> 15l / min without mechanical ventilation
    6. There are no contraindications to the use of standard symptomatic treatment in accordance with the guidelines of PTEiLChZ.
    E.4Principal exclusion criteria
    The patient's inability to comply with the protocol in opinion of the Investigator
    1. Intake of any experimental anti-COVID-19 study drugs
    2. Intake of any plasma therapy, in particular plasma therapy with COVID-19 convalescents
    3. Infection with human immunodeficiency virus (HIV)
    4. Pregnancy or breastfeeding
    5.All conditions that the doctor qualifying for the study considers harmful to the patient participating in this study, including any clinically significant deviations from normal clinical laboratory values ​​or concurrent medical events or situations that prevent the proper performance of the study (e.g. insufficient knowledge of the Polish language by the patient in the opinion of the researcher)
    6. Participation in another interventional clinical trial in the last 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    No oxygen supplementation required on Day 7 and 14 from the start of the therapy.

    Secondary endpoints:
    Safety-related endpoints:
    1. Occurrence of serious adverse events up to day 28 from the start of study therapy

    Effectiveness-related endpoints:
    1. The need for mechanical ventilation in the patient
    2. Time of using oxygen therapy
    3. The need to use tocilizumab or other anti-cytokine drugs
    4. Time to discharge from hospital
    5. Time to negative PCR test for SARS-CoV-2 virus RNA
    6. Occurrence of any COVID-19 related symptoms on day 28
    Exploratory endpoints 1. Changes in inflammatory parameters and coagulation parameters at successive time points
    2. Presence of lung tissue pathology after completion of therapy
    3. Generation of a specific humoral response: Presence and titer of anti-SARS-CoV-2 antibodies during the therapy and after the observation period (on day 28 from the start of study therapy)
    Punkty końcowe związane z bezpieczeństwem:
    1. Występowanie poważnych działań niepożądanych w okresie do 28 dnia od rozpoczęcia terapii badanej

    Punkty końcowe związane ze skutecznością:
    1. Konieczność zastosowania u pacjenta wentylacji mechanicznej
    2. Czas stosowania tlenoterapii
    3. Konieczność stosowania tocilizumabu lub innych leków przeciwcytokinowych
    4. Czas do wypisania ze szpitala
    5. Czas do uzyskania negatywnego wyniku badania PCR w kierunku RNA wirusa SARS-CoV-2
    6. Występowanie jakichkolwiek objawów związanych z COVID-19 w dniu 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Change of inflammatory parameters and parameters of the coagulation system at successive time points
    2. Presence of lung tissue pathology after completion of therapy
    3. Generation of a specific humoral response: Presence and titer of anti-SARS-CoV-2 antibodies during the therapy and after the observation period (on day 28 from the start of study therapy)
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/D
    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 Yes
    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) 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 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 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 concerned5
    E.8.5The trial involves multiple Member States No
    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 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
    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: 336
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 144
    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 state480
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 480
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-31
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