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    Summary
    EudraCT Number:2020-001857-31
    Sponsor's Protocol Code Number:PLX-COV-03
    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:2020-07-21
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-001857-31
    A.3Full title of the trial
    A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to test if a drug called PLX-PAD is both safe and can help in the treatment of COVID-19 patients
    A.4.1Sponsor's protocol code numberPLX-COV-03
    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 SponsorPluristem Ltd.
    B.1.3.4CountryIsrael
    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 supportPluristem Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPluristem Ltd.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressMatam Park, Building 05
    B.5.3.2Town/ cityHaifa
    B.5.3.3Post code3508409
    B.5.3.4CountryIsrael
    B.5.4Telephone number+972747107198
    B.5.5Fax number+972747108765
    B.5.6E-mailudin@Pluristem.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 namePLX-PAD
    D.3.4Pharmaceutical form Dispersion 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.3.8INN - Proposed INNemiplacel
    D.3.9.3Other descriptive namePLX-PAD
    D.3.9.4EV Substance CodeSUB193883
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number300
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberEMA/556256/2015 The EMA/CAT considers the product as Tissue Engineered Product.
    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
    Pneumonia or Acute Respiratory Distress Syndrome (ARDS) caused by severe COVID-19 disease
    E.1.1.1Medical condition in easily understood language
    COVID-19–related critical illness
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    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
    To evaluate the efficacy and safety of intramuscular (IM) administration of PLX-PAD for the treatment of severe COVID-19
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the inclusion criteria listed below to be eligible for the study:
    1. Willing and able to provide written informed consent, or with a legal representative (as defined by local regulation) who can provide informed consent.
    2. Male or non-pregnant female 18 to 85 years of age at time of randomization.
    3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen within up to 28 days prior to randomization.
    4. Meets definition of ARDS according to Berlin criteria with oxygenation of PaO2/FIO2 ≤ 200 mm Hg (graded as Moderate or Severe).
    5. By the time of expected treatment initiation on invasive mechanical ventilation for less than 72 hours.
    6. Women of childbearing potential must have a negative serum pregnancy test at primary screening and must be willing to use at least one highly effective birth control method throughout the study. Any female subject who is surgically sterile, or with bilateral tubal occlusion, or whose partner is vasectomized, or who reliably applies sexual abstinence or who is postmenopausal (one year without menses) will be considered not of childbearing potential.
    E.4Principal exclusion criteria
    Subjects with any one of the exclusion criteria listed below will not be eligible for the study (based on medical record at current admission):
    1. Mild ARDS as defined by Berlin criteria (200 mm Hg < PaO2/FIO2 ≤ 300mmHg)
    2. Body weight under 55 kg (121 lbs)
    3. Stage 4 and above chronic kidney disease (clearly defined in patient’s medical history, eGFR <30 mL/min/1.73m2 [based on MDRD equation]) or patients that require renal replacement therapy for any reason at time of primary screening.
    4. Serum creatinine level of over 3 mg/dL at last test before randomization.
    5. Total Bilirubin ≥3 mg/dL at last test before randomization.
    6. Continuous administration of vasoactive agents required due to shock at time of randomization (either one): dopamine >15 (mcg/kg/min), vasopressin >0.04 (units/min), phenylephrine >1 (mcg/kg/min), epinephrine ≥0.3 (mcg/kg/min), or norepinephrine ≥0.3 (mcg/kg/min).
    7. Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
    8. Stroke or acute myocardial infarction within 3 months before current hospital admission.
    9. Congestive heart failure (New York Heart Association [NYHA] class III-IV) at primary screening (stated in medical history) or investigator discretion as to presence of moderate to severe baseline congestive heart failure.
    10. Chronic Obstructive Pulmonary disease GOLD stage above III (Stated in medical history or investigator discretion of severe COPD.
    11. Other chronic pulmonary disease under chronic oxygen treatment.
    12. Known medical history of Acquired immunodeficiency syndrome (AIDS) or HIV under chronic treatment.
    13. Known medical history of Active acute or chronic HBV or HCV (recovered patients are allowed).
    14. Known medical history of active tuberculosis or active tuberculosis including under treatment at time of primary screening (not including latent TB).
    15. Pre-existing significant coagulopathies that put the patient at an increased risk of major bleeding according to the Investigator’s judgment.
    16. History of thromboembolism or known chronic hypercoagulopathic syndrome\state.
    17. Subjects under acute or chronic anticoagulant therapy (warfarin with international normalized ratio (INR) >2 or Direct Oral Anticoagulants, or full dose subcutaneous or intravenous treatment for atrial fibrillation and\or prosthetic heart valves, and or suspicion or proven thromboembolic events), unless this therapy is required and can be safely modified, according to local clinical routines (e.g. PTT monitoring, timing of low molecular heparin injections), around the time of PLX-PAD injections based on the study Investigator’s/ treating physician’s discretion and patient’s risk of bleeding.
    18. Subject is currently enrolled in another* controlled clinical trial(s) with investigational drug, unless in long-term follow-up phase (in which there is no IP administration).
    *patients enrolled in another clinical trial in which the investigational product is an anticoagulant may be included in the study.
    19. Exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening.
    20. History of solid organ transplantation.
    21. Active malignancy or history of malignancy within 3 years prior to screening except for successfully resected skin basal cell carcinoma or skin squamous cell carcinoma.
    22. Treatment with extracorporeal membrane oxygenation (ECMO) support (at time of randomization).
    23. In the opinion of the Investigator, the subject is unsuitable for participating in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Number of ventilator free days (time-frame of 28 days from Day 1 through Day 28 of the study, inclusive)
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28
    E.5.2Secondary end point(s)
    1. All-cause mortality (Time frame 28 and 60 days)
    2. Duration of mechanical ventilation (Time frame 28 and 60 days)
    3. Mean improvement relative to baseline on a 7-point ordinal scale (Time frame 28 and 60 days):
    •Not hospitalized, no limitations on activities
    •Not hospitalized, limitation on activities;
    •Hospitalized, not requiring supplemental oxygen;
    •Hospitalized, requiring supplemental oxygen;
    •Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    •Hospitalized, on invasive mechanical ventilation or ECMO;
    •Death.
    4. Ordinal outcome assessed daily while hospitalized and on Days 14 and 28
    5. ICU-free days (time frame 28 and 60 days)
    6. Hospitalization-free days (time frame 60 days)
    7. Proportion of subjects with suspected or confirmed Pulmonary Fibrosis (Time frame 52 weeks)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. days 1,2,3,4,7,14,28,60
    2. days 28 and 60
    3. days 1,7,14,28,60
    4. days 1,2,3,4,7,14,28
    5. days 28 and 60
    6. days 28 and 60
    7. Week 52
    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 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 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
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Bulgaria
    Germany
    Israel
    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 months6
    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 months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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
    The study will be conducted in intubated, mechanically ventilated subjects suffering from respiratory failure and ARDS due to COVID-19. The subjects are very likely to be sedated.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 40
    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. There is no further administration of the product (PLX-PAD) to the patients after completion of participation in the study.
    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 Decision2020-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-15
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