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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2022-000736-37
    Sponsor's Protocol Code Number:1001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-08-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-000736-37
    A.3Full title of the trial
    A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with CAP including COVID-19 pneumonia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with CAP including COVID-19 pneumonia.
    A.3.2Name or abbreviated title of the trial where available
    TRICOVID
    A.4.1Sponsor's protocol code number1001
    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 SponsorBiotest AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiotest AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLandsteinerstrasse 5
    B.5.3.2Town/ cityDreieich
    B.5.3.3Post code63303
    B.5.3.4CountryGermany
    B.5.6E-mailclinical.trials@biotest.com
    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 nameTrimodulin
    D.3.2Product code BT588
    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.3.9.3Other descriptive nameTrimodulin (human IgM, IgA, IgG solution)
    D.3.9.4EV Substance CodeSUB215556
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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
    non-severe community-acquired pneumonia (CAP) or moderate or severe Coronavirus Disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    non-severe community-acquired pneumonia (CAP) or moderate or severe Coronavirus Disease 2019 (COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084380
    E.1.2Term COVID-19 pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    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 main objectives of the trial are to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia
    E.2.2Secondary objectives of the trial
    Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the subject or legally acceptable/authorized representative (LAR) in compliance with all local legal requirements.
    2. Hospitalized, adult (≥ 18 years of age) subject (any gender).
    3. Diagnosis of CAP (e.g., according to ATS/IDSA guideline) or COVID-19 pneumonia (e.g., according to local guidelines) before or within 48
    hours after hospital admission, and with radiologic evidence (available from routine SoC done before or after hospital admission) showing new
    pulmonary lobar or multilobar infiltrates consistent with CAP or COVID-19 pneumonia
    4. Receiving oxygen supply via low-flow oxygen (LFO, by mask or nasal prongs with > 2 L/min) or on non-invasive ventilation (NIV) or high-flow oxygen (HFO) at start of treatment with investigational medicinal product (IMP).
    5. Fulfilling at least one of the following clinical respiratory parameters within 24 hours prior to start of treatment:
    - SpO2 ≤ 94% (on room air, and without preceding chronic lung disease);
    - 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg under HFO or NIV;
    - Radiologic evidence of COVID-19 pneumonia.
    6. C-reactive protein (CRP) ≥ 50 mg/L and ≤ 150 mg/L within 24 hours prior to start of treatment with IMP.
    7. D-dimer ≤ 3 mg/L and platelets ≥ 130 x109/L within 24 hours prior to start of treatment with IMP.
    8. Treatment with investigational medicinal product (IMP) has to be started within 7 days after first hospital-admission for CAP or COVID-19 pneumonia.
    9. Subject must receive SoC treatment for CAP or COVID-19 pneumonia.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women.
    2. Subjects of child bearing potential not willing to use reliable contraceptive measures during the trial and for 15 weeks after the last IMP treatment.
    3. Subject on invasive mechanical ventilation (IMV) and/or extracorporeal membrane oxygenation (ECMO) or predicted to be on IMV and/or ECMO at start of IMP treatment.
    4. Subject with septic shock and in need for vasopressors at start of IMP treatment.
    5. Subject with sustained improvement in any form of oxygen supply (e.g. change from IMV to NIV/HFO/LFO, or change from HFO to LFO) during the last 7 days or with predicted cessation of oxygen supply at start of treatment.
    6. Severe neutropenia (neutrophil count < 0.5 x109/L) assessed within 24 hours prior to start of treatment.
    7. Hemoglobin < 7g/dL assessed within 24 hours prior to start of treatment.
    8. Pre-existing hemolytic disease.
    9. Pre-existing thrombosis or acute thromboembolic events (TEEs) (e.g. cerebrovascular accidents, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis) within 3 months before entering the trial. Subjects particularly at risk for TEEs caused by other reasons than the current pneumonia (e.g. history of thrombophilia, permanent immobilization, or permanent paralysis of
    lower extremities).
    10. Subject on dialysis or with severe renal impairment, estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² assessed
    within 24 hours prior to start of treatment.
    11. Subject with end stage renal disease (ESRD), or primary focal segmental glomerulosclerosis (FSGS).
    12. Pre-existing severe lung diseases concomitant to current pneumonia (e.g., COPD (GOLD stage III-IV / Group D), severe interstitial lung
    disease [including idiopathic pulmonary fibrosis], cystic fibrosis, active tuberculosis, chronically infected bronchiectasis, aspiration pneumonia
    or active lung cancer).
    13. Pre-existing decompensated heart failure (New York Heart Association class III–IV).
    14. Pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh C score ≥ 9 points), or hepatocellular carcinoma.
    15. Known intolerance to proteins of human origin or known allergic reactions to any of the components of trimodulin / placebo.
    16. Selective, absolute immunoglobulin A (IgA) deficiency with known antibodies to IgA.
    17. Known human immunodeficiency virus infection.
    18. Life expectancy of less than 90 days, according to the Investigator’s clinical judgment, because of medical conditions related neither to current pneumonia nor to associated medical complications.
    19. Morbid obesity with high body mass index ≥ 40 kg/m², or malnutrition with low body mass index < 16 kg/m².
    20. Treatment with polyvalent immunoglobulin preparations, plasma, or albumin preparations during the last 21 days before entering the trial.
    21. Ongoing treatment with exploratory selective immune modulators (targeted and anti-inflammatory drugs) like cytokine inhibitors, receptor inhibitors, kinase inhibitors) (Exceptions: corticosteroids, non-steroidal anti-inflammatory drugs [NSAIDs] and previous use of COVID-19 guideline recommended immune modulating drugs if for treatment of COVID-19).
    22. Treatment with fluoroquinolone preparations, during the last 5 days before entering the trial.
    23. Treatment with any type of interferon during the last 21 days before entering the trial.
    24. Ongoing treatment with immunosuppressants like anti-proliferative/anti-cancer drugs, drugs used in transplantation or autoimmune diseases (Exception: corticosteroids).
    25. Participation in another interventional clinical trial (using medications and/or procedures not according to SoC of the trial site) within 30 days before screening, or previous participation in this clinical trial.
    26. Employee or direct relative of an employee of the contract research organization, the trial site, or Biotest.
    27. Persons, subject to legal protection measures, if applicable according to local laws.
    E.5 End points
    E.5.1Primary end point(s)
    Composite primary endpoint: Deterioration / mortality rate
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Clinical deterioration (increment of at least 1 category on the 9-category ordinal-scale from baseline) between day 6 and day 29
    - 28-day all-cause mortality between day 1 and day 29
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    - Clinical deterioration rate (day 6-29)
    - Clinical deterioration rate (day 1-29)
    - 28-days all-cause mortality rate on day 29
    - 90-days all-cause mortality rate on day 91
    - Time to recovery to score ≤ 2 until day 29
    - Proportion of subjects with score ≤ 2 on day 29
    - Proportion of subjects improved, unchanged, and deteriorated/died compared to baseline at several days
    - Proportion of subjects with PaO2/FiO2 ratio < 100, 100 to < 200, 200 to < 300 or ≥ 300 on days 7, 14, 21, 29
    - Days of IMV/ECMO until day 29
    - Proportion of subjects on IMV/ECMO until day 29
    - Days with oxygen supply until day 29
    - Proportion of subjects with oxygen supply on days 7, 14, 21, 29
    - Days in intensive care unit (ICU) until day 29
    - Proportion of subjects in ICU until day 29
    - Days of hospitalization until day 29

    Secondary safety endpoints:
    - Number, severity, causality, outcome, and seriousness of all adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest (AESIs), infusional TEAEs, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial through day 29 [+3]
    - Number of all infusion-related TEAEs through day 29 [+3]
    - Number, severity, causality, and outcome of all serious adverse events (SAEs) through day 29 [+3]
    - Dose modifications (incl. reductions and changes in infusion rate)
    - Distribution and changes over time for safety, laboratory, vital signs parameters, and ECG

    Secondary PK endpoints:
    Changes from baseline, during and after treatment:
    - Serum concentration of IgM, IgA, and IgG

    Secondary PD endpoints:
    Changes from baseline, during and after treatment:
    - Factors and markers of coagulation
    - Markers of inflammation
    - Complement factors
    - Biomarkers
    - Anti-SARS-CoV-2 and anti-S. pneumoniae titers
    E.5.2.1Timepoint(s) of evaluation of this end point
    Included in E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Chile
    Colombia
    Peru
    Brazil
    Israel
    Mexico
    South Africa
    Turkey
    United Kingdom
    Austria
    Belgium
    Denmark
    Estonia
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Poland
    Portugal
    Slovakia
    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
    The end of this clinical trial (Study 1001) is defined as the Last Visit of the Last Subject. The Last Visit is the closing visit done on day 91 [+10], or a telephone interview on day 91 [+10] in case the Last Subject is discharged before day 91, or has been transferred to another hospital.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 2022-08-22. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 390
    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 Decision2022-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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