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    Summary
    EudraCT Number:2020-001493-29
    Sponsor's Protocol Code Number:CVC-for-COVID-19
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-14
    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 - BfArM
    A.2EudraCT number2020-001493-29
    A.3Full title of the trial
    Charité trial of Cenicriviroc (CVC) treatment for COVID-19 patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Charité trial of Cenicriviroc (CVC) treatment for COVID-19 patients
    A.3.2Name or abbreviated title of the trial where available
    CVC for COVID-19
    A.4.1Sponsor's protocol code numberCVC-for-COVID-19
    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 SponsorCharité - Universitaetsmedizin Berlin
    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 supportCharité - Universitaetsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitaetsmedizin Berlin
    B.5.2Functional name of contact pointDept. of Hepatology and Gastroenter
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number4930450 553022
    B.5.6E-mailfrank.tacke@charite.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 nameCenicriviroc
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCENICRIVIROC MESYLATE
    D.3.9.1CAS number 497223-28-6
    D.3.9.3Other descriptive nameCENICRIVIROC MESYLATE
    D.3.9.4EV Substance CodeSUB168627
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective of the study is to compare the efficacy of Cenicriviroc (CVC) plus standard of care (SOC) versus SOC alone in participants with COVID-19 with respect to achieving a meaningful response in clinical condition.
    E.2.2Secondary objectives of the trial
    Key secondary and secondary objectives:
    1. Evaluate the clinical efficacy of CVC relative to the control arm in patients hospitalized with COVID-19 with respect to improvement in clinical condition, as assessed by respiratory and laboratory assessments.
    2. To compare hospital resource utilization in patients receiving CVC relative to the control arm in participants with COVID-19.

    3. To compare respiratory progression in patients receiving CVC versus placebo in participants with COVID-19 [Daily assessment while inpatient]
    4. Evaluate the safety of CVC as compared to the placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject provides written informed consent prior to initiation of any study procedures. Understands and agrees to comply with planned study procedures.
    2. Male or non-pregnant female adult ≥18 years of age at time of enrolment.
    3. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR (date of sample collection maximal 10 days prior to randomization) and fulfils the case criteria of COVID-19 (One or more of the following must be met in lieu of a positive PCR test: fever [defined as a temperature
    ≥ 100.0°F / 37.8°C documented within 24 hr. of randomization] , absolute and relative lymphopenia and leukopenia, new typical infiltrates in x-ray of the chest or chest CT scan [only if obtained for clinical reasons; not required by study], no improvement on antibiotics).
    4. Scoring a “3” or “4” (or “5”, at the Investigator’s discretion) on the cited 7-Point Ordinal Scale at enrolment.
    o Note, if scoring a “2” at screening, inclusion will be met if the patient is in the process of being hospitalized or admitted to an inpatient setting. Such a patient would be assigned a “3” at enrolment for Baseline assessment purposes
    5. No participation in other clinical trials according to AMG (3 months before) at the time of this trial
    E.4Principal exclusion criteria
    1. ALT/AST > 5 times the upper limit of normal.
    2. Patients with severe hepatic impairment (defined as liver cirrhosis Child stage B or C)
    3. Stage 4 chronic kidney disease or requiring dialysis (i.e. eGFR < 30 ml/min)
    4. Advanced cardiac (eg, severe heart failure [NYHA III-IV])
    or pulmonary diseases which, in the Investigator's judgment, would not make participation appropriate.
    5. Pregnancy or breast feeding.
    6. Anticipated transfer to another hospital which is not a study site within 72 hours.
    7. Known allergy or hypersensitivity to CVC or its components
    8. Use of medications that are contraindicated with CVC and that could not be replaced or stopped during the trial period
    9. Administration of specified drugs which interfere with the metabolism of CVC (see listing in protocol body for allowed or disallowed medication and CVC’s drug metabolism pathway (section 9.1.13)
    10. Patients immediately or imminently requiring mechanical ventilation.
    11. Patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
    12. Subjects who are legally detained in an official institution
    13. Subjects that are unsuitable to understand or to comply with the study requirements or in the opinion of the investigator
    14. Subjects who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Endpoint will be the subject’s responder status defined by achieving a score of “1” or “2” (discharged from hospital e.g.) on Day 15 on the following 7-point scale:

    1. Not hospitalized, no limitations on activities
    2. Not hospitalized, limitation on activities;
    3. Hospitalized, not requiring supplemental oxygen;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, on non-invasive ventilation or high-flow oxygen devices;
    6. Hospitalized, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation);
    7. Death.
    E.5.2Secondary end point(s)
    Key Secondary Endpoints
    • 7-point ordinal scale to be assessed on Day 15 (and Day 1 for baseline comparison), analyses of:
    o ordinal improvement of 2 or more, compared with baseline
    o ordinal improvement of 1 or more, compared with baseline

    • with 7-point ordinal scale assessed on: Days 8, 22, 29 (and Day 1 for baseline comparison), analyses of:
    o Responder status (achieving a score of a “1” or a “2”)
    o ordinal improvement of 2 or more, compared with baseline
    o ordinal improvement of 1 or more, compared with baseline

    • Length of time spent in the hospital (days)
    • Length of time spent in the ICU (days)
    • Days alive and out of hospital through Day 29.
    • Days free of endotracheal tube-based ventilation (or ECMO) through Day 29

    Secondary endpoints
    • 7-point Ordinal Scale outcome, assessed while hospitalized
    o Time to an ordinal improvement of 2 or more, compared with baseline (i.e. start of trial participation)
    o Time to an ordinal improvement of 1 or more, compared with baseline (i.e. start of trial participation)
    o Subject clinical status using ordinal scale at Days 3, 5, 8, 29, and 85
    • National Early Warning Score (NEWS) assessed daily while hospitalized
    o The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
    o Change from baseline to Days 3, 5, 8, 15, and 29 in NEWS
    • Duration of supplemental oxygen (if applicable)
    • Exogenous oxygen free days in the first 28 days (to Day 29).
    • Incidence of new oxygen use during the study
    • duration of new oxygen use during the study
    • Mechanical Ventilation:
    o Ventilator free days in the first 28 days (to Day 29).
    o Incidence and duration of new mechanic ventilation
    • Mortality
    o 14 -day mortality
    o 28-day mortality
    o 12-week mortality
    • Evaluate the safety of the intervention through 84 days of follow-up as compared to the control arm as assessed by:
    o Cumulative incidence of serious adverse events (SAEs) through Day 85 of follow-up.
    o Cumulative incidence of Grade 3 and 4 AEs.
    o Drug discontinuation (for any reason)
    o Changes in white cell count, haemoglobin, platelets, creatinine, amylase, lipase, glucose, total bilirubin, ALT and AST over time.
    o ECGs to be examined for customary parameters plus for potential signs of myocarditis
    • Date and cause of death (if applicable).
    • Grade 3 and 4 adverse events
    • SAEs.
    • Pulmonary function by PFT on Day 85
    • Echocardiographic assessments, where available
    • Inflammatory cytokines and chemokines, white cell count, monocyte and neutrophil counts, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST on Days 1; 3, 5, 8, (while hospitalized); and Day 15 and 29 (if able to return to clinic or still hospitalized).
    • Status of SARS-CoV-2 Infection on Days 8, 15, 29 and 85, as assessed by PCR test
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 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

    Study Duration: The study will last for up to 3 years.

    Participant Duration: An individual subject will complete the study in about 90 days, from screening at Day -1 or 1 to follow-up on Day 85 ±5 days.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    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: 200
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state200
    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)
    After completing all the protocol treatment and visits, patients will continue with regular visits according to usual practice and need.
    In the case of premature termination, the reason for withdrawal must be entered on the appropriate case report form (CRF) page and must be followed for safety and efficacy until 8 weeks after discontinuation.
    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 Decision2020-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-06
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