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    Clinical Trial Results:
    Charité trial of Cenicriviroc (CVC) treatment for COVID-19 patients

    Summary
    EudraCT number
    		 2020-001493-29
    Trial protocol
    		 DE  
    Global end of trial date
    06 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2023
    First version publication date
    22 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVC-for-COVID-19
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04500418
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité - Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Dept. of Hepatology and Gastroenter, Charité - Universitaetsmedizin Berlin, 49 30450 553022, frank.tacke@charite.de
    Scientific contact
    Dept. of Hepatology and Gastroenter, Charité - Universitaetsmedizin Berlin, 49 30450 553022, frank.tacke@charite.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main 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.
    Protection of trial subjects
    The trial was conducted in accordance with the declaration of Helsinki and principles of Good Clinical Practice.
    Background therapy
    		 The rationale for CVC use to prevent the “cytokine storm” and respiratory tissue inflammation that results from COVID-19 in infected patients with severe pulmonary dysfunction is based on CVC’s ability to block the recruitment of inflammatory CCR2- (monocytes) and CCR5- (lymphocytes) expressing cells to the lung tissue and thus reduce the resulting inflammation-induced tissue damage.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    45
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 1 study centers at Charité - Universitätsmedizin Berlin, between 10-Sep-2020 (Date of first enrolment) and 27-Jul-2021 (Date of last completed).

    Pre-assignment
    Screening details
    		 A total of 837 subjects entered the screening period, of whom 792 were screening failures.45 subjects were recruited and randomized. Two of them withdrawal after randomization. Inclusion criteria: adult, SARS-CoV-2-infection confirmed by PCR, 7-point scale score "3" or "4" at enrolment, male or no-pregnant female subjects

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cenicriviroc
    Arm description
    		 Subjects received Cenicriviroc (CVC) plus standard of care
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenicriviroc mesylate
    Investigational medicinal product code
    497223-28-6
    Other name
    Cenicriviroc
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Day 1: 450 milligrams (mg) loading dose of CVC (300mg AM, 150 mg PM) and on Day 2-28: CVC BID 150 mg (AM/PM). Every dose should be taken with food (within 30 min).

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo plus standard of care ....
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Day 1: 450 milligrams (mg) Placebo (300mg AM, 150 mg PM) and on Day 2-28: BID PLacebo 150 mg (AM/PM). Every dose should be taken with food (within 30 min).

    Number of subjects in period 1 [1]
    		Cenicriviroc Placebo
    Started
    27
    16
    Completed
    26
    16
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 38 /42 (90.5%) of the mITT could be followed up for the primary endpoint. Two participants, 1 (placebo) and 1(CVC) withdrew consent after intake of two doses and four doses, and disagreed to further follow up. For two other participants we have been lost contact to one scheduled study visit in time, but continued the study and followed-up with the later study visits.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cenicriviroc
    Reporting group description
    		 Subjects received Cenicriviroc (CVC) plus standard of care

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo plus standard of care ....

    Reporting group values
    		 Cenicriviroc Placebo Total
    Number of subjects
    		 27 16 43
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 57.5 (51.8 to 66.8) 61.5 (50.8 to 68.5) -
    Gender categorical
    Units: Subjects
        Female
    		 7 2 9
        Male
    		 20 14 34
    Comorbidities
    Units: Subjects
        BMI >30 kg/m2
    		 14 7 21
        Asthma
    		 2 0 2
        COPD
    		 4 0 4
        NYHA I or II
    		 1 0 1
        no cormorbidity
    		 6 9 15
    Baseline score on 7-Point ordinal scale
    Subjects responder status defined by the 7-point scale. 1 = not hospitalized, no limitation on activities 2 = not hospitalized, limitation on activities 3 = hospitalized, not requiring supplement oxygen 4 = hospitalized, requiring supplemental oxygen 5 = hospitalized, on non-invasive mechanical ventilation (IMV) or high-flow oxygen devices 6 = hospitalized, on invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO) 7 = Death
    Units: Subjects
        Score 3
    		 3 3 6
        Score 4
    		 22 13 35
        Score 5
    		 1 0 1
        not recorded
    		 1 0 1
    Body mas index (BMI)
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 31.4 (26.2 to 33.1) 28.0 (25.9 to 33.3) -
    Days from onset to admission
    Units: days
        median (inter-quartile range (Q1-Q3))
    		 7.1 (4.8 to 9.6) 7.7 (5.8 to 9.8) -
    Days from admission to randomization
    Units: Days
        median (inter-quartile range (Q1-Q3))
    		 1.51 (1.1 to 2) 1.21 (1 to 2) -
    Days from symptom onset to randomization
    Units: days
        median (inter-quartile range (Q1-Q3))
    		 8.7 (6.6 to 10.5) 9.5 (8 to 10.8) -
    CRP
    Units: mg/l
        median (inter-quartile range (Q1-Q3))
    		 88.3 (55.6 to 114.6) 53.3 (36.5 to 74.6) -
    PCT
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    		 0.09 (0.01 to 0.1) 0.11 (0.1 to 0.2) -
    IL-6
    Units: ng/l
        median (inter-quartile range (Q1-Q3))
    		 30.2 (18.9 to 54.8) 16.5 (6.8 to 23.4) -
    Ferritin
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    		 929.4 (532.9 to 1242.6) 1140 (593.8 to 1776.8) -

    End points

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    End points reporting groups
    Reporting group title
    Cenicriviroc
    Reporting group description
    		 Subjects received Cenicriviroc (CVC) plus standard of care

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo plus standard of care ....

    Primary: Responder outcome Score points " 1 or 2" on 7-point ordinal scale

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    End point title
    		 Responder outcome Score points " 1 or 2" on 7-point ordinal scale
    End point description
    Responder status defined be achieving a "1" or "2" on 7-point ordinal scale- was conducted with binary logistic regression analysis. Responder (yes/no) was included at the outcome variable, treatment group as main effect and strata variables (baseline status 3 vs. 4 or 5 and Comorbidities (yes/no). Due to the small sample size, Firth-Regression was conducted by efficacy analysis. Odds Ratios with 95 % Confidence limits and p- values are reported. A total of 38 /42 (90.5%) of the mITT could be followed up for the primary endpoint. Two participants, 1 (placebo) and 1 (CVC) withdrew consent after intake of two doses and four doses, and disagreed to further follow up. For two other participants we have been lost contact to one scheduled study visit in time, but continued the study and followed-up with the later study visits.
    End point type
    Primary
    End point timeframe
    day 15 after receiving drug or placebo
    End point values
    		 Cenicriviroc Placebo
    Number of subjects analysed
    26
    16
    Units: subjects
        not recorded
    3
    1
        Score " 1 or 2" on 7-point ordina
    19
    14
        no Score "1 or 2"
    4
    1
    Statistical analysis title
    		 CVC vs Placebo
    Comparison groups
    Cenicriviroc v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 2.24
    Statistical analysis title
    		 BL Score category 4 or 5 vs. Score 3
    Comparison groups
    Cenicriviroc v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 3.6
    Statistical analysis title
    		 comorbidities present vs. not present
    Comparison groups
    Cenicriviroc v Placebo
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 8.7

    Secondary: Score improvement baseline to day 15

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    End point title
    		 Score improvement baseline to day 15
    End point description
    End point type
    Secondary
    End point timeframe
    from baselinte to day 15
    End point values
    		 Cenicriviroc Placebo
    Number of subjects analysed
    26
    16
    Units: subjects
    23
    15
    No statistical analyses for this end point

    Secondary: Oridinal Score day 15

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    End point title
    		 Oridinal Score day 15
    End point description
    End point type
    Secondary
    End point timeframe
    day 15
    End point values
    		 Cenicriviroc Placebo
    Number of subjects analysed
    26
    16
    Units: subjects
        Score 1
    0
    2
        Score 2
    19
    12
        Score 3
    2
    1
        Score 4
    1
    0
        Score 5
    1
    0
        no improvement Score
    3
    1
    No statistical analyses for this end point

    Secondary: Days to improvement of 7-point-Score

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    End point title
    		 Days to improvement of 7-point-Score
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Cenicriviroc Placebo
    Number of subjects analysed
    26
    16
    Units: days
    median (inter-quartile range (Q1-Q3))
        Score >= 1
    5 (4 to 7)
    6 (4 to 7)
        Score >= 2
    14 (7 to 22.2)
    14 (7 to 14)
    No statistical analyses for this end point

    Secondary: NEW Score

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    End point title
    		 NEW Score
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Cenicriviroc Placebo
    Number of subjects analysed
    26
    16
    Units: subjects
        NEW score ever <= 2
    24
    13
        Days until NEW Score <= 2
    26
    15
    No statistical analyses for this end point

    Secondary: secondary outcomes

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    End point title
    		 secondary outcomes
    End point description
    End point type
    Secondary
    End point timeframe
    overall trial
    End point values
    		 Cenicriviroc Placebo
    Number of subjects analysed
    26
    16
    Units: days
    median (inter-quartile range (Q1-Q3))
        Days spent in hospital
    6.5 (5 to 8.8)
    6 (4 to 7.5)
        Days spent in ICU
    0 (0 to 0)
    0 (0 to 0)
        IN-hospital days with oxygen
    5 (3 to 7)
    4 (1 to 5.5)
        exog. oxygen free days in the first 28 d
    23 (21 to 25)
    24 (22.5 to 27)
    No statistical analyses for this end point

    Secondary: SARS-CoV-2 PCR results

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    End point title
    		 SARS-CoV-2 PCR results
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8 and Day 15
    End point values
    		 Cenicriviroc Placebo
    Number of subjects analysed
    26
    16
    Units: subjects
        result "positive d8"
    16
    5
        result "positive d15"
    9
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from vist 1 to visit 11
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Cenicriviroc (CVC)
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Cenicriviroc (CVC) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 27 (37.04%)
    1 / 16 (6.25%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Incomplete cardiac systole with short CPR
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Stroke volume
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stroke
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multi-organ disorder
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia aspiration
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cenicriviroc (CVC) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 27 (92.59%)
    13 / 16 (81.25%)
    Investigations
    increased alanine transaminase (ALT/ALAT)
         subjects affected / exposed
    14 / 27 (51.85%)
    8 / 16 (50.00%)
         occurrences all number
    19
    8
    increased aspartate aminotransferase (AST/ASAT)
         subjects affected / exposed
    7 / 27 (25.93%)
    4 / 16 (25.00%)
         occurrences all number
    7
    4
    increased gamma glutamyl transferase (GGT)
         subjects affected / exposed
    6 / 27 (22.22%)
    1 / 16 (6.25%)
         occurrences all number
    6
    1
    increased amylase
         subjects affected / exposed
    7 / 27 (25.93%)
    3 / 16 (18.75%)
         occurrences all number
    8
    3
    increased GOT (glutamic oxalacetic transaminase)
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    increased GPT (Glutamat-Pyruvat-Transaminase)
         subjects affected / exposed
    5 / 27 (18.52%)
    3 / 16 (18.75%)
         occurrences all number
    6
    3
    increased alkaline phosphatase
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    increased lipase
         subjects affected / exposed
    7 / 27 (25.93%)
    4 / 16 (25.00%)
         occurrences all number
    10
    4
    decreased Carbon monoxide diffusing capacity
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 16 (6.25%)
         occurrences all number
    3
    1
    Vital capacity abnormal
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 27 (18.52%)
    2 / 16 (12.50%)
         occurrences all number
    6
    2
    Cardiac disorders
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    myocardial repolarisation disorder
         subjects affected / exposed
    4 / 27 (14.81%)
    0 / 16 (0.00%)
         occurrences all number
    8
    0
    Sinus tachycardia
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    3
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 16 (6.25%)
         occurrences all number
    3
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 16 (0.00%)
         occurrences all number
    6
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 16 (12.50%)
         occurrences all number
    3
    2
    Hypoxia
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    Skin and subcutaneous tissue disorders
    rash/ exanthema
         subjects affected / exposed
    4 / 27 (14.81%)
    3 / 16 (18.75%)
         occurrences all number
    5
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2020
    update study protocol V.1.2: new - interim safety monitoring, reduced key secondary endpoints, new laboratory parameters, change in inclusion criteria
    08 Feb 2021
    update study protocol V.1.3; Changes in safety or integrity of trial subjects Changes in interpretation of scientific documents/value of the trial
    09 Apr 2021
    update study protocol V.1.4, Changes in safety or integrity of trial subjects (discontinuation criteria), Changes in interpretation of scientific documents/value of the trial
    04 Sep 2021
    update study protocol V.1.5, Changes in safety or integrity of trial subjects, Changes in interpretation of scientific documents/value of the trial

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated before reaching the targeted goal of patients due to persistent recruitment problems despite intensive efforts an due to declining case numbers during spring and summer months. Study recruitment started with a delay.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36572146
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