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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2020-005305-54
    Sponsor's Protocol Code Number:CPI-006-003
    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:2021-02-16
    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 number2020-005305-54
    A.3Full title of the trial
    Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of CPI-006 plus standard treatment versus placebo plus standard treatment in hospitalized Covid-19 patients with mild to moderate symptoms
    A.4.1Sponsor's protocol code numberCPI-006-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04734873
    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 SponsorCorvus Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportCorvus Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCorvus Pharmaceuticals, Inc
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address863 Mitten Road, Suite 102
    B.5.3.2Town/ cityBurlingame, California
    B.5.3.3Post code94010
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@corvuspharma.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 nameCPI-006
    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 INNmopadulimab
    D.3.9.1CAS number 308067-58-5
    D.3.9.3Other descriptive nameIMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB20618
    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 placeboSolution 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
    Covid-19 disease
    E.1.1.1Medical condition in easily understood language
    Covid-19 disease
    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 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
    To compare the proportion of participants alive and respiratory failure free during the 28 days after dosing with CPI-006 plus SOC versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection
    E.2.2Secondary objectives of the trial
    - To compare the time to recovery of CPI-006 plus SOC versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection
    - To compare the time to clinical improvement of CPI-006 plus SOC versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection
    - To compare the mortality rate due to any cause during the 28 days after dosing with CPI-006 plus SOC versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants must be ≥ 18 years of age at the time of signing the informed consent.
    2. Confirmed positive by PCR or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to the day of randomization. PCR is the preferred method; however other tests for SARS-CoV-2 are allowed if authorized for use in the country.
    3. Covid-19 illness of any duration of symptoms.
    4. Participant capable of understanding the study and giving informed consent. Participant capable of signing and dating the written ICF. Participant must understand and agree to comply with planned study procedures for the duration of the study. The study visits beyond Day 28 will be optional and require a separate consent.
    5. Hospitalized for Covid-19 illness for ≤ 5 days with mild to moderate Covid-19 symptoms including:
    - Mild: Symptoms of Covid-19 including fever, rhinorrhea, mild cough, sore throat, headache, muscle pain, malaise but not requiring supplemental oxygen
    - Moderate: Lower respiratory symptoms: shortness of breath (SOB) or signs of pneumonia or lung infiltrates based on X-ray or computed tomography (CT) scan < 50% present
    And Meets the criteria for:
    - Category 4 - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise) OR
    - Category 5 - Hospitalized, requiring supplemental oxygen, OR
    - Category 6 - Hospitalized, on non-invasive ventilation or high flow oxygen devices per 8-point ordinal scale.
    6. Adequate organ function
    7. Eligible participants of child-bearing age (male or female) must agree to use adequate contraception for a total of 6 weeks after study treatment administration.
    E.4Principal exclusion criteria
    1. Signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening (and randomization) or anticipated impending need for mechanical ventilation.
    2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
    3. Any uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit (ICU).
    4. Participants with malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of Screening.
    5. Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited to) biologics such as anti-CD20, anti-TNF, anti-IL6, anti-IL6 receptor; alkylating agents (e.g., cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use equivalent to prednisone >10 mg/day, during preceding 2 months.
    Note: Steroids for treatment of Covid-19 are acceptable.
    6. Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered less than 24 hours prior to randomization. Participants must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study.
    7. Patients who are participating in other clinical trials including participants in an extended access program.
    8. Active deep vein thrombosis or pulmonary embolism as confirmed by the investigator within last 6 months.
    9. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 48 hours of admission as confirmed by the investigator.
    10. Any active uncontrolled co-morbid disease that might interfere with study conduct or interpretation of findings.
    11. Known to be positive for HIV or positive test for chronic HBV infection (defined as positive hepatitis B surface antigen [HbsAg]) or positive test for hepatitis C antibody.
    12. Pregnancy or breast feeding.
    13. Persons under legal protection or currently incarcerated.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of participants who are alive and free from respiratory deterioration during the 28 days after dosing defined as follows per the 8-point ordinal scale:
    - Deterioration to Categories 6, 7, or 8 for a participant who entered the trial at Categories 4 or 5
    - Deterioration to Categories 7 or 8 for a participant who entered the trial at Category 6
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after dosing
    E.5.2Secondary end point(s)
    The following endpoints will be compared between Treatments A, B and C:
    Key Secondary Endpoints:
    • Time to recovery during the 28 days after dosing. Day of recovery is defined as the first day on which the participant satisfies 1 of the following 3 categories from the 8-point ordinal scale: 1) Not hospitalized, no limitations on activities.; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
    • Time to clinical improvement determined by ≥ 2 points improvement inthe 8-point ordinal scale during the 28 days after dosing.
    • Proportion of participants who died during the 28 days after dosing.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 7, 14, 21, and 28 days from baseline
    - 7, 14, 21, and 28 days from baseline
    - 28 days after dosing
    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) No
    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 No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Canada
    Chile
    Colombia
    Israel
    Mexico
    Peru
    South Africa
    Ukraine
    United States
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Poland
    Romania
    Spain
    United Kingdom
    Czechia
    Argentina
    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
    Last Visit Last Subject
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 434
    F.4.2.2In the whole clinical trial 1000
    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)
    No study treatment will be provided to study participants at the end of
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-07-15
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