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    Summary
    EudraCT Number:2020-001936-86
    Sponsor's Protocol Code Number:COMET
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-08-20
    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 number2020-001936-86
    A.3Full title of the trial
    A prospective, randomized, open label Phase 2 clinical trial to evaluate superiority of anti-SARS-CoV-2 convalescent plasma versus standard-of-care in hospitalized patients with mild COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate superiority of anti-SARS-CoV-2 convalescent plasma versus standard-of-care in hospitalized patients with mild COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Convalescent Plasma in Mild Covid-19 for Early Treatment
    A.4.1Sponsor's protocol code numberCOMET
    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 SponsorHannover Medical School
    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 supportGerman Federal Ministry of Health
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHannover Medical School
    B.5.2Functional name of contact pointInstitute of Transfusion Medicine
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115326701
    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 Fresh frozen plasma (FFP) with marketing authorisation in Germany issued by PEI
    D.2.1.1.2Name of the Marketing Authorisation holderHannover Medical School and other German MAH for FFP participating in this study
    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 nameGefrorenes Apherese-COVID-19-RKP Leukozytendepletiert
    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.3.8INN - Proposed INNFRESH FROZEN PLASMA
    D.3.9.3Other descriptive nameFRESH FROZEN PLASMA
    D.3.9.4EV Substance CodeSUB33671
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number230 to 270
    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 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
    Hospitalized patients with mild SARS-CoV-2 infection (WHO R&D Blueprint Ordinal Scale for Clinical Improvement = 3 or 4)
    E.1.1.1Medical condition in easily understood language
    Hospitalized patients with mild COVID-19
    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 LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of convalescent plasma for the treatment of hospitalized patients with mild COVID-19 infection
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of experimental regimen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients infected with SARS-CoV-2 virus and
    1. age ≥ 18 years and ≤ 75 years
    2. fulfills RKI case definition including a positive verification of a SARS-CoV-2 infection from any specimen (e.g. respiratory, blood, other bodily fluid)*
    * confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap)
    3. mild disease defined by the following criteria:
    - Hospitalized (score 3 or 4 of WHO R&D Blueprint ordinal scale for clinical improvement)
    4. signed written informed consent and willingness to comply with treatment and follow-up procedures
    5.
    ► men;
    or
    ► women without childbearing potential defined as follows:
    • at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy,
    • hysterectomy or uterine agenesis,
    • ≥ 50 years and in postmenopausal state > 1 year, or
    • < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening;
    or
    ► women with childbearing potential:
    • who are practicing true abstinence from sexual intercourse (periodic abstinence and withdrawal are not acceptable),
    • who have sexual relationship with female partners only and/or with sterile male partners, or
    • who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial.
    E.4Principal exclusion criteria
    1. Accompanying diseases other than COVID-19 with an expected survival time of less than 12 months
    2. In the opinion of the clinical team, progression to death is imminent and inevitable with-in the next 24 hours, irrespective of the provision of treatment
    3. Chronic obstructive lung disease (COPD), stage 4
    4. Lung fibrosis with UIP pattern in CT und severe emphysema
    5. Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to ≤ 30%
    6. Liver cirrhosis Child C
    7. Liver failure: Bilirubin > 5xULN and elevation of ALT /AST (at least one >10xULN).
    8. End stage renal failure requiring hemodialysis
    9. Organ or bone marrow transplant in the three month prior to screening
    10. History of adverse reactions to plasma proteins
    11. Known deficiency of immunoglobulin A
    12. Pregnancy and breastfeeding women
    13. Volume overload until sufficiently treated
    14. Pulmonary edema
    15. Body mass index (BMI) > 40 kg/m2
    16. Participation in another clinical trial, especially for treatment of COVID-19
    17. Allergy or other contraindication to one of the investigational products
    18. Previous treatment with SARS-CoV-2 convalescent plasma
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with treatment failure on day 14. A treatment failure is defined as pro-gression of COVID-19 disease. Progression is defined as score 5, 6, 7 or 8 of WHO R&D Blueprint ordinal scale for clinical improvement.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    1. Failure rates at day 7, day 21, day 28
    2. Time to clinical improvement (defined as time from randomization to an improvement of two points on the WHO R&D Blueprint ordinal scale for clinical improvement)
    3. Adverse events
    4. All-cause mortality (ACM) on day 7, day 14, day 21, day 28, 4 months
    5. Length of hospital stay
    6. Deterioration in health (progressive disease)
    7. Need of ventilation support / additional organ support, e.g. ECMO
    8. Time until virus clearance from body sites (negative SARS-CoV-2 PCR in nasopharyngeal sample)
    9. Predictive value of comorbidities and inflammation and coagulation markers on clinical improvement, mortality, length of hospital stay and necessity of transfer to ICU
    10. Feasibility of collection of plasma units from donors who recovered from a SARS-CoV-2 infection
    11. Level of identity of kinetics of anti-SARS-CoV-2 antibodies in plasma of patients compared to plasma of donors (Kinetics of antibodies detectable in the patient after convalescent plasma treatment, Pharmacokinetic parameters: The maximum observed anti-SARS-CoV-2 (Cmax), and the time to Cmax (tmax) will be determined directly from the anti-SARS-CoV-2 versus time data. The observed titer at the end of a dosing interval (Ctrough) will also be determined directly from the anti-SARS-CoV-2 versus time data. Calculated parameters [apparent terminal phase elimination rate constant (b), terminal phase elimination half-life (t1/2), and the area under the curve (AUC)] will be estimated using non compartmental analysis with PK-Sim software. Accumulation ratios will be calculated based on the AUC values of the consecutive dosing intervals and the Cmax values of the consecutive dosing intervals.)
    12. Titer of neutralizing anti-SARS-CoV-2 in transfused plasma units
    13. Impact of donor characteristics on humoral response against anti-SARS-CoV-2 (age; gender; severity of COVID-19; interval between resolution of symptoms and plasmapheresis).
    14. Course of anti-SARS-CoV-2 titer in patients (prior to transfusion of convalescent plasma, on day 1 & 2 and after transfusion (day 3 and 7) as well as every week thereafter up to day 28).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 7, day 21, day 28
    2. From randomization to an improvement of two points on the WHO R&D Blueprint ordinal scale for clinical improvement
    3. From transfusion on day 1 until day 120
    4. Day 7, day 14, day 21, day 28, 4 months
    5. From hospitalization until end of hospitalisation
    6. Throughout the study
    7. From screening until day 28
    8. At screening, day 2, 4 and 6 and every week thereafter up to day 28
    9. -11. Throughout the study
    12. Prior to transfusion
    13. Throughout the study
    14. Prior to transfusion of convalescent plasma on day 1 & 2 and after transfusion (day 3 and 7) as well as every week thereafter up to day 28
    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 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 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
    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 months10
    E.8.9.1In the Member State concerned 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 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 state340
    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 Decision2020-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-11-15
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