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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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:2020-001335-28
    Sponsor's Protocol Code Number:IFX-1-P2.9
    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:2020-04-03
    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 number2020-001335-28
    A.3Full title of the trial
    A pragmatic adaptive randomized controlled Phase II/III multicenter study of IFX-1 in Patients with severe COVID-19 Pneumonia - "PANAMO"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II/III study of IFX-1 in patients with severe COVID-19 Pneumonia
    A.3.2Name or abbreviated title of the trial where available
    Panamo
    A.4.1Sponsor's protocol code numberIFX-1-P2.9
    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 SponsorInflaRx GmbH
    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 supportInflaRX GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInflaRX GmbH
    B.5.2Functional name of contact pointClinical Research and Development
    B.5.3 Address:
    B.5.3.1Street AddressWinzerlaer Strasse 2
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07745
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989414 1897897
    B.5.6E-mailkorinna.pilz@inflarx.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 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 nameIFX-1
    D.3.2Product code vilobelimab
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIFX-1
    D.3.9.1CAS number 2250440-41-4
    D.3.9.2Current sponsor codeIFX-1
    D.3.9.3Other descriptive namevilobelimab
    D.3.9.4EV Substance CodeSUB193626
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution 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
    Severe pneumonia in context of COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe lung inflammation caused by 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10035737
    E.1.2Term Pneumonia viral
    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 of Phase II was:
    • To explore the effect of IFX-1 on COVID-19 related severe pneumonia (hypothesis generating)

    The primary objective of Phase III is
    • To demonstrate the efficacy of IFX-1 to improve survival outcomes of severe COVID-19 pneumonia (confirmative)
    E.2.2Secondary objectives of the trial
    The secondary objectives of Phase II and Phase III are:
    • To assess and define other parameters of efficacy
    • To assess the safety of IFX-1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase II
    1. At least 18 years of age or older
    2. Clinically evident or otherwise confirmed severe pneumonia as evidenced by at least one of the following criteria:
    3. Chest X-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) with pulmonary infiltrates consistent with pneumonia
    4. Clinical history in past 14 days of newly developed severe shortness of breath (> 29 breaths / minute) in the absence of oxygen supply or
    spontaneous peripheral oxygenation ≤ 92 with need for oxygen supply, or need for non-invasive or invasive ventilation (in conjunction with a
    positive test for SARS-CoV-2 infection)
    5. Oxygenation index at time of enrollment (PaO2 / FiO2) ≤ 250 and ≥ 100 in supine position
    6. SARS-CoV-2 infection confirmation (tested positive in last 14 days or test results to be obtained within 24h after enrollment, both with locally
    available test system).
    7. No use OR stop of any corticosteroid treatment at time point of enrollment (topical treatment and systemic dose of ≤ 10mg prednisone /
    day equivalent allowed)

    Phase III
    1. At least 18 years of age or older
    2. Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP randomization)
    3. Patients with a PaO2 / FiO2 ratio of < 200 and > 60 at randomization
    (one representative measurement within 6h before randomization)
    4. SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system).
    E.4Principal exclusion criteria
    Phase II
    1. Oxygenation index at time of enrollment (PaO2 / FiO2) < 100 or >
    250 in supine position
    2. Intubated > 48h at time point of enrollment
    3. Patients who demonstrate an improvement in past 24h prior to
    enrollment in oxygenation and ventilation / support parameters which
    indicate an expected resolution of lung dysfunction in the next 24h
    without additional intervention according to judgment of the investigator
    with one or more of the following parameters present:
    4. Improvement in oxygenation index of > 30% relative to previous
    measure (last 24h in supine position)
    5. Extubation if intubated before
    6. Known history of chronic obstructive pulmonary disease (COPD)
    (GOLD category C or D)
    7. Known history of chronic dialysis OR received renal replacement
    therapy in past 14 days
    8. Received new other biologic treatment attempt for COVID-19 in the
    past 14 days
    9. Received treatment with a viral replication inhibitor in past 3 days
    10. Known hypersensitivity to IFX-1 or any other ingredient of the study
    medication
    11. Known pregnancy
    12. Received organ or bone marrow transplantation in past 3 months
    13. Known mechanically resuscitation in past 14 days
    14. Patient moribund or expected to die in next 12h according to the
    judgment of the investigator
    15. Patients otherwise considered restricted from receiving full
    supportive care (including ICU support)
    16. Existing diagnosis of progressed cancer or other life-limiting disease
    with life expectancy < 6 months
    17. Known to have received anti-cancer therapy for oncological disease
    in past 4 weeks
    18. Known severe congestive heart failure (New York Heart Association
    [NYHA] Class III-IV; see Appendix 8)

    Phase III
    1. Intubated > 48h at time point of first IMP randomization
    2. Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator
    3. Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization
    4. Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months
    5. Treatment of COVID-19 with investigational antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health [NIH] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment[s] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.)
    6. At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be documented at study initiation and throughout the conduct of the study.)
    7. Received cytokine adsorption therapy in past 3 days
    8. Known hypersensitivity to IFX-1 or any other ingredient of the study medication
    9. Serum or urine pregnancy test positive before randomization (required for women of childbearing potential)
    10. Received organ or bone marrow transplantation in past 3 months
    11. Known cardio-pulmonary mechanical resuscitation in past 14 days
    12. Patient moribund or expected to die in next 24h according to the judgment of the investigator
    13. Known to have received anti-cancer therapy for hemato-oncological disease in past 4 weeks OR known to have active malignant disease at time point of randomization
    14. Known severe congestive heart failure (corresponding to e.g. NYHA Class III-IV, left ventricular ejection fraction <40%; see Appendix 8)
    15. Known history of chronic liver disease (Child-Pugh B or C; see Appendix 11)
    16. Participating in or has participated in other investigational interventional studies (drug or device) within the last 7 days before randomization
    E.5 End points
    E.5.1Primary end point(s)
    Phase II:
    The primary endpoint in Phase II was the relative change (%) from baseline (day 1 prior to study drug administration at ± 1h of randomization) in Oxygenation Index (PaO2 / FiO2) in supine position at day 5.

    Phase III:
    Based on the preliminary interim analysis of efficacy data from Phase II, the primary endpoint chosen for Phase III is 28-day all-cause mortality.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    Phase II:
    • Number of patients (%) achieving an Early Response as defined as meeting ALL of the following criteria at day 7 after enrollment:
    ➢ Patient alive and extubated OR oxygenation index ≥ 300 OR improvement of ≥ 30% from baseline
    ➢ Temperature < 38°C in absence of fever decreasing medication of at least 4h
    ➢ White blood cell count within normal limit of local lab quantifications
    • Number of patients (%) reaching a Late Response as defined by either being discharged alive from hospital until day 28 OR meeting ALL of the following criteria at day 28 of the trial
    ➢ Patient alive and extubated
    ➢ Patient discharged from intensive care unit (ICU)
    ➢ Patient free of shortness of breath (respiratory rate [RR] < 20) in absence of oxygen supply
    ➢ Patient free of fever (< 37.6°C)
    • Relative change (%) from baseline (day 1 prior to study drug administration at ± 1h of randomization) in oxygenation index (PaO2 / FiO2) in supine position at day 3, 7, 9, and 11.
    • All cause 28-day mortality (%)
    • Frequency, severity, and relatedness to study drug of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Phase III:
    • 60-day all-cause mortality (proportion of patients deceased until Day 60)
    • Proportion of patients with an improvement in the 8-point ordinal scale (Appendix 7) (day 15, day 28)
    • Proportion of patients developing acute kidney failure (eGFR < 15 mL/min/1.73m², assessed by the CKD-EPI equation requiring race information) during ICU stay and at day 28
    • Proportion of patients free of any renal replacement therapy within 28 days upon randomization
    • Frequency, severity, and relatedness to study drug of serious and non-serious TEAEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the conduct of the study until Day 60
    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 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) 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 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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Best Supportive Care / 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Brazil
    Mexico
    Peru
    Russian Federation
    South Africa
    United States
    Belgium
    France
    Germany
    Netherlands
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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
    Deferred consent or another legally acceptable local consent procedure for ICU patients. Due to severity of disease patients might be unable to provide informed consent before the beginning of the trial mainly due to being on mechanical ventilation.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 430
    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 Decision2020-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-01
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