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    Summary
    EudraCT Number:2021-002098-25
    Sponsor's Protocol Code Number:ZKSJ0137_INFLIXCOVID
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-002098-25
    A.3Full title of the trial
    A randomized, controlled, multicenter, open label phase II clinical study
    to evaluate infliximab in the treatment of patients
    with severe COVID-19 disease (INFLIXCOVID)
    Eine randomisierte, kontrollierte, multizentrische, offene Phase-II-Studie zur Evaluation von Infliximab in der Behandlung von Patienten mit schwerem COVID-19-Verlauf (INFLIXCOVID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An unblinded clinical trial investigating the active substance infliximab in the treatment of severe COVID-19 at multiple study centers
    Unverblindete klinische Studie zur Untersuchung des Wirkstoffs INFLIXIMAB bei der Behandlung von schwerem COVID-19 an mehreren Prüfzentren
    A.3.2Name or abbreviated title of the trial where available
    INFLIXCOVID
    INFLIXCOVID
    A.4.1Sponsor's protocol code numberZKSJ0137_INFLIXCOVID
    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 SponsorFriedrich-Schiller-Universität Jena
    B.1.3.4CountryGermany
    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 supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportCelltrion Healthcare Hungary Kft.
    B.4.2CountryHungary
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Jena
    B.5.2Functional name of contact pointZentrum für Klinische Studien
    B.5.3 Address:
    B.5.3.1Street AddressSalvador Allende-Platz 27
    B.5.3.2Town/ cityJena 07747
    B.5.3.3Post codePostfach
    B.5.3.4CountryGermany
    B.5.4Telephone number004936419396655
    B.5.5Fax number004936419399969
    B.5.6E-mailZKS-Projektmanagement@med.uni-jena.de
    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 Yes
    D.2.1.1.1Trade name Remsima
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRemsima
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.3Other descriptive nameInfliximab
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 COVID-19
    schwerer COVID-19 Verlauf
    E.1.1.1Medical condition in easily understood language
    severe COVID-19
    schwere COVID-19 Erkrankung
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy of the TNF-α antibody infliximab in the treatment of patients with severe COVID-19 compared with the standard of care (SOC).
    Evaluation der Effektivität des TNF-α-Antikörpers Infliximab in der Behandlung von Patienten mit schwerer COVID-19-Erkrankung im Vergleich zur Standardtherapie (SOC)
    E.2.2Secondary objectives of the trial
    •Assessment of the effect of infliximab on the morbidity and prognosis of patients with COVID-19.
    • Assessment of the effect of infliximab on an excessive immune response in patients with COVID-19.
    • Assessment of the effect of infliximab on the morbidity and prognosis of patients with COVID-19.
    • Characterization of the study cohort and course of the disease
    •Assessment of the effect of infliximab on the incidence of a cardiomyopathy on days 3 and 7 after randomization in patients with COVID-19.
    •Beurteilung der Sicherheit des TNF-α-Antikörpers Infliximab in der Behandlung von Patienten mit schwerer COVID-19-Erkrankung
    •Beurteilung des Effekts von Infliximab bei Patienten mit COVID-19 auf eine überschießende Immunreaktion
    •Beurteilung des Effekts von Infliximab bei Patienten mit COVID-19 auf die Morbidität und Prognose
    •
    •Beurteilung des Effekts von Infliximab bei Patienten mit COVID-19 auf die Inzidenz einer Kardiomyopathie am Tag 3 (V1) und 7 (V2) nach Randomisierung
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    •Collection and storage of blood and urine samples for the investigation of translational research questions by analysing biomarkers of organ, metabolic, genetic and immunological function and regulation.
    •Comparison of the course of disease of patients with severe COVID-19 and previously generated datasets from patients with sepsis and healthy subjects.
    •Asservierung von Blut- und Urinproben für translationale Fragestellungen außerhalb dieser klinischen Prüfung zur Beantwortung derer Biomarker für die Organ-, Stoffwechsel-, Gen- und immunologische Funktion und Regulation analysiert werden sollen
    •Vergleich des Krankheitsverlaufs von Patienten mit schwerer COVID-19-Erkrankung mit den bereits generierten Datensätzen von Patienten mit Sepsis und gesunden Probanden
    E.3Principal inclusion criteria
    •Age ≥ 18 years
    • Infection with SARS-CoV-2 (virus detection by means of a PCR test not older than 72 hours)
    • Bipulmonary infiltrates (detection by means of X-rays or computed tomography)
    • COVID inflammation score ≥ 10 (see Appendix of study protocol 14.1)
    • Ferritin concentration (serum or plasma) ≥ 500 ng / ml
    • Arterial oxygen saturation ≤ 93% when breathing room air
    • written informed consent from the patient
    • Potentially childbearing women: negative pregnancy test
    •Alter ≥ 18 Jahre
    •Infektion mit SARS-CoV-2 (Virusnachweis mittels PCR-Test nicht älter als 72 Stunden)
    •Bipulmonale Infiltrate (Nachweis mittels Röntgen oder Computertomographie)
    •COVID-Inflammationsscore ≥ 10 (siehe Anlage 14.1 )
    •Ferritinkonzentration (Serum oder Plasma) ≥ 500 ng/ml
    •Arterielle Sauerstoffsättigung ≤ 93 % unter Raumluft
    •schriftliche Einwilligung des Patienten
    •bei potentiell gebärfähigen Frauen: negativer Schwangerschaftstest
    E.4Principal exclusion criteria
    In medical history:
    Contraindications study medication:
    • Hypersensitivity to the active substance infliximab (or any of the other ingredients of the medicine) or to other murine proteins
    • active or latent tuberculosis
    • acute or chronic hepatitis B
    • severe infections such as invasive fungal infections, bacterial sepsis, or abscesses
    • opportunistic infections (e.g. pneumocystosis, listeriosis)
    • moderate or severe heart failure (NYHA class III / IV)
    • Immunosuppression (e.g. organ transplantation, AIDS, leukopenia)
    • Malignancies or lymphoproliferative diseases or chemotherapy within the last 4 weeks
    • Multiple sclerosis or peripheral demyelinating diseases, including the Guillain-Barré syndrome
    • Treatment with other biologics for therapy for approved indications of infliximab (e.g. for rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis)

    Further exclusion criteria:
    • Autoimmune disease with biologics therapy
    • Current treatment with TNF antibodies, convalescent plasma, bamlanivimab, or other experimental treatments for COVID-19
    • High-flow oxygen therapy, non-invasive / invasive ventilation (WHO-COVID-19 PROGRESSION Scale> 5)
    • pre-existing long-term ventilation or home oxygen therapy
    • Child-Pugh C liver cirrhosis
    • Pregnancy or breastfeeding
    • Patients with a life expectancy <90 days due to other medical conditions
    • Limitation or discontinuation of therapy (e.g. refusal of artificial ventilation)
    • Participation in another interventional study
    • Previous participation in this study
    • Interdependence between the patient and the coordinating investigator or other members of the study team
    Anamnestisch bekannt:
    Kontraindikationen Studienmedikation:
    •Überempfindlichkeit gegen den Wirkstoff Infliximab (oder einen der sonstigen Bestandteile des Arzneimittels) oder gegen andere murine Proteine
    •aktive oder latente Tuberkulose
    •akute oder chronische Hepatitis B
    •schwere Infektionen wie invasive Pilzinfektionen, bakterielle Sepsis oder Abszesse
    •opportunistische Infektionen (z. B. Pneumocystose, Listeriose)
    •mäßiggradige oder schwere Herzinsuffizienz (NYHA-Klasse III/IV)
    •Immunsuppression (z. B. Organtransplantation, AIDS, Leukopenie)
    •Malignome oder lymphoproliferative Erkrankungen bzw. Z. n. Chemotherapie innerhalb der letzten 4 Wochen
    •Multiple Sklerose bzw. periphere demyelinisierende Erkrankungen, einschließlich des Guillain-Barré-Syndroms
    •Behandlung mit anderen Biologika zur Therapie im Zulassungsbereich von Infliximab (z. B. bei Rheumatoide Arthritis, Morbus Crohn, Colitis Ulcerosa, ankylosierende Spondylitis, Psoriasis-Arthritis, Psoriasis)


    weitere Ausschlusskriterien:
    •Autoimmunerkrankung mit Biologikatherapie
    •laufende Behandlung mit TNF-Antikörper, Rekonvaleszenten-Plasma, Bamlanivimab oder andere experimentelle Verfahren zur Behandlung von COVID-19
    •High-Flow-Beatmung, nicht-invasive/invasive Beatmung (WHO-COVID-19 PROGRESSION Scale > 5)
    •vorbestehende Langzeit-Beatmung oder Heim-Sauerstofftherapie
    •Leberzirrhose Child-Pugh C
    •Schwangerschaft oder Stillzeit
    •Patienten mit Lebenserwartung < 90 Tage aufgrund von Nebenerkrankungen
    •Therapielimitierung oder -einstellung (z. B. Ablehnung künstlicher Beatmung)
    •Teilnahme an einer anderen Interventionsstudie
    •vorherige Teilnahme an dieser Studie
    •Abhängigkeitsverhältnis zum LKP oder Mitgliedern der Prüfgruppe
    E.5 End points
    E.5.1Primary end point(s)
    28-day mortality
    28-Tage-Mortalität
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time of primary analysis after day 90 of last patient (LVLS)
    Zeitpunkt der Primäranalyse nach Tag 90 des letzten Patienten (LVLS)
    E.5.2Secondary end point(s)
    • Frequencies of adverse events (AEs) and serious adverse events (SAEs)
    • Assessing the effect of infliximab in patients with COVID-19 on an excessive immune response:
    o Change in the interleukin-6 (IL-6) concentration in the blood from randomization to day 7 (V2) and day 14 (V3) after randomization
    o Change in ferritin concentration in the blood from randomization to day 7 (V2) and 14 (V3) after randomization
    o Change in the lymphocyte count from randomization to day 7 (V2) and 14 (V3) after randomization
    • Assessment of the effect of infliximab in patients with COVID-19 on morbidity and prognosis:
    o Assessment of the severity and frequency of organ failure: ventilation-free days, vasopressor-free days, renal replacement therapy-free days up to day 28 (V4) after randomization
    o Rate of occurrence of severe acute respiratory failure (ARDS) up to day 28 (V4) after randomization
    o WHO-COVID-19-Progression Scale on 7./14./28. Day (V2–4) after randomization
    o Rate of admission to the intensive care unit after randomization up to day 28 (V4)
    o Duration of the hospital and intensive care unit stay after randomization up to day 28 (V4)
    o Mortality rate 14 (V3) and 90 days (V5) after randomization
    o Quality of life and long-term consequences 90 days (V5) after randomization
    • Assessment of the effect of infliximab in patients with COVID-19 on the incidence of cardiomyopathy on days 3 (V1) and 7 (V2) after randomization

    Aims of the substudy:
    •Collection and storage of blood and urine sample for the investigation of translational research questions by analysing biomarkers of organ, metabolic, genetic and immunological function and regulation.
    •Comparison of the course of disease of patients with severe COVID-19 and previously generated datasets from patients with sepsis and health subjects.
    •Häufigkeiten von adverse events (AEs) und serious adverse events (SAEs)
    •Beurteilung des Effekts von Infliximab bei Patienten mit COVID-19 auf eine überschießende Immunreaktion:
    oVeränderung der Interleukin-6 (IL-6)-Konzentration im Blut von Randomisierung zu Tag 7 (V2) und Tag 14 (V3) nach Randomisierung
    oVeränderung der Ferritin-Konzentration im Blut von Randomisierung zu Tag 7 (V2) und 14 (V3) nach Randomisierung
    oVeränderung der Lymphozytenzahl von Randomisierung zu Tag 7 (V2) und 14 (V3) nach Randomisierung
    •Beurteilung des Effekts von Infliximab bei Patienten mit COVID-19 auf die Morbidität und Prognose:
    oBeurteilung der Schwere und Häufigkeit von Organversagen: Beatmungs-freie Tage, Vasopressor-freie Tage, Nierenersatztherapie-freie Tage bis Tag 28 (V4) nach Randomisierung
    oRate des Auftretens eines schweren akuten Lungenversagens (ARDS) bis Tag 28 (V4) nach Randomisierung
    oWHO-COVID-19-Progression Scale am 7./14./28. Tag (V2–4) nach Randomisierung
    oRate der Aufnahme auf die Intensivstation nach Randomisierung bis Tag 28 (V4)
    oDauer des Krankenhaus- und Intensivstationsaufenthalts nach Randomisierung bis Tag 28 (V4)
    oMortalitätsrate 14 (V3) und 90 Tage (V5) nach Randomisierung
    oLebensqualität und Langzeitfolgen 90 Tage (V5) nach Randomisierung
    •Beurteilung des Effekts von Infliximab bei Patienten mit COVID-19 auf die Inzidenz einer Kardiomyopathie am Tag 3 (V1) und 7 (V2) nach Randomisierung

    Ziele der Substudie:
    •Asservierung von Blut- und Urinproben für translationale Fragestellungen außerhalb dieser klinischen Prüfung zur Beantwortung derer Biomarker für die Organ-, Stoffwechsel-, Gen- und immunologische Funktion und Regulation analysiert werden sollen
    •Vergleich des Krankheitsverlaufs von Patienten mit schwerer COVID- 19-Erkrankung mit den bereits generierten Datensätzen von Patientenmit Sepsis und gesunden Probanden
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time of primary analysis after day 90 of last patient (LVLS)
    Zeitpunkt der Primäranalyse nach Tag 90 des letzten Patienten (LVLS)
    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) 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standardtherapie
    Standard of Care
    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 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
    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 months3
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 2021-05-19. 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 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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 88
    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)
    A causal therapy for COVID-19 does not exist at the time this protocol was drawn up. All supportive treatments recommended for these patients will continue to be used after the clinical trial.
    Eine kausale Therapie von COVID-19 existiert zum Zeitpunkt der Erstellung dieses Prüfplans nicht. Alle supportiven Behandlungen, die für diese Patienten empfohlen werden, werden auch nach der klinischen Prüfung angewendet.
    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 Decision2021-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-31
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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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