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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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:2021-000399-12
    Sponsor's Protocol Code Number:GPHIP_0202
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-000399-12
    A.3Full title of the trial
    A Randomized, Open-Label, Multi-Centre, Phase 2a Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects with Severe COVID-19 Pneumonia
    Een gerandomizeerde, open-label, multicentrische fase 2 studie om de veiligheid en het effect te bepalen van STC3141 wat als een continue infuus toegediend wordt bij patiënten met ernstige pneumonie ten gevolge van COVID19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial in COVID19 patients suffering from severe lung infection to evaluate the safety and effect of infusion with STC3141
    A.4.1Sponsor's protocol code numberGPHIP_0202
    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 SponsorGrand Medical Pty Ltd
    B.1.3.4CountryAustralia
    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 support
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTRIUM Clinical Consulting
    B.5.2Functional name of contact pointProject Manager Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressBaron Opsomerlaan 32
    B.5.3.2Town/ cityLier
    B.5.3.3Post code2500
    B.5.3.4CountryBelgium
    B.5.6E-mailmpgyselen@triumclinicalconsulting.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.3.2Product code STC3141
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    severe pneumonia due to COVID-19
    E.1.1.1Medical condition in easily understood language
    severe lung infection due to corona virus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    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.1.3Condition 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 evaluate the safety of STC3141 in subjects with severe COVID-19 pneumonia
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the preliminary effects of STC3141 in the treatment of subjects with severe COVID-19 pneumonia.
    As an exploratory objective, the change in biomarkers from baseline following STC3141 treatment will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1. Males and non-pregnant females who are 18 years or older (inclusive).
    2. Signed informed consent.
    Subjects are to provide informed consent prior to any study procedures being performed. Consent can be oral if a written consent cannot be expressed. Where it is not practicable to approach a subject highly dependent on medical care, or the subject is not capable of making such a decision, consent will be sought from the legal representative of the subject. Subjects enrolled in the study based on consent by the legal representative will be given the opportunity to provide written confirmatory consent when and if they become able to do so. If the subject declines to confirm consent, they will be withdrawn from the study at the point where they decline consent.
    3. Virological diagnosis of SARS-CoV-2 infection (documentation of real-time PCR or equivalent within the last 7 days, positive results is available before screening)
    4. Hospitalized due to clinical/chest image diagnosis of sever pneumonia.
    Severe pneumonia defined as either dyspnea, or SpO2 on room air at rest ≤93% or PaO2/FiO2 <300 mmHg.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. Subjects who have renal impairment at screening, defined as an estimate glomerular filtration rate (eGFR) <45 ml/min/BSA
    2. Subjects requiring extracorporeal membrane oxygenation (ECMO) at screening
    3. Subjects who are on invasive mechanical ventilator more than 72 hours
    4. Female subjects of child-bearing potential (as judged by the Investigator) who do not agree to remain abstinent or use medically acceptable methods of contraception (e.g., implants, injectable, combined oral contraceptives, intrauterine devices [IUDs], double‑barrier protection) during the study. Male participants who do not agree to use a condom with spermicide during intercourse (if not surgically sterilized) during the study.
    5. Subjects who receive anticoagulants overall (except subtherapeutic doses of heparin which is ≤ 6000IU twice a day Enoxaparin or equivalence) including but not limited to warfarin, rivaroxaban, apixaban, dabigatran acenocoumarol, fencoumarol, or other parenteral anticoagulants at randomization. Antiplatelets drugs are allowed
    6. Subjects who have International Normalized ratio or INR>1.3XULN.
    7. Subjects who have Absolute Neutrophil Count (ANC) <1,000/μL.
    8. Subjects who have platelets count <80,000 /μL.
    9. Subjects who have activated Partial Thromboplastin Time (aPTT) >1.5XULN.
    10. Severe anaemia (haemoglobin < 7.0 g/dL).
    11. Bleeding in the past 24 hours requiring blood transfusion.
    12. Women who are pregnant or lactating at Screening or planning to conceive (self or partner) at any time during the study, including the follow-up period.
    13. Subjects who have the following chronic organ dysfunction or immunosuppression:
    a. Heart: New York heart association cardiac function IV.
    b. Lung: severe lung diseases other than COVID-19 lead to home oxygen therapy.
    c. Kidneys: renal impairment requiring chronic dialysis
    d. Liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; the upper digestive tract hemorrhage caused by portal hypertension; or previous liver failure/hepatic encephalopathy/hepatic coma.
    e. Immune function: IV chemotherapy and radiotherapy within 4 weeks before screening or use of immunosuppressive medication within 2 weeks before screening including but not limited to: tacrolimus, cyclosporin, sirolimus, mycophenolate or azathioprine etc., or subjects with leukemia, lymphoma or acquired immunodeficiency syndrome [AIDS].
    14. Solid organ or bone marrow transplantation within 4 weeks.
    15. The following conditions occurring within 4 weeks prior to screening:
    a. Acute pulmonary embolism
    b. Acute coronary syndrome such as myocardial infarction, unstable angina pectoris etc.
    16. Known allergy to the active ingredient of STC3141 or its excipients (i.e., phosphate buffer).
    17. The investigator consider participation in the study is not in the best interests of the subjects.
    18. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the subject; affect study endpoints or decrease the chance of obtaining satisfactory data required to achieve the objectives of the study.
    19. Any other severe or unstable medical condition that, in the opinion of the Investigator or Sponsor, could be expected to progress, recur, or change to such an extent that it could put the subject at special risk, or bias the assessment of the clinical or mental status of the subject to a significant degree.
    20. Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    To assess safety, the incidence of adverse events, treatment emergent adverse events and serious adverse events up to Day 30
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to day 30
    E.5.2Secondary end point(s)
    - Changes of CRP, D-dimer, TBL, ALT, eGFR, aPTT, and LDH from baseline over time
    • Changes of PaO2/FiO2 ratio from baseline over time
    • Changes of PaO2/FiO2 ratio from baseline over time for subjects who are on invasive or non-invasive ventilator
    • Changes of SOFA score from baseline over time
    Changes of SOFA score components from baseline over time
    • Time to invasive mechanical ventilation
    • Time to independence from non-invasive mechanical ventilation
    • Time to independence from oxygen therapy
    • Duration of hospitalization
    • All-cause mortality rate on Day 30
    • Subgroup analysis

    Exploratory Endpoints：
    • Changes from baseline in MPO (NETs), citrullinated histone (H3 in plasma) and IL-1b, IL-2, IL-6, IL-8/CXCL8, IL-10, IFN-γ, TNF-α, IL-12/P70
    E.5.2.1Timepoint(s) of evaluation of this end point
    see separate end points
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Effect of the IMP
    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) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard of care at the study site
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    legal representative will be asked to give informed consent in case the subject is incapable of giving consent personally
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-07
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