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    Clinical Trial Results:
    An open-label, multi-centre, randomised trial comparing different doses of single-dose tocilizumab in adults with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive decline in respiratory function and evolving systemic inflammation on time to intubation, non-invasive ventilation and/or all-cause mortality

    Summary
    EudraCT number
    		 2020-001767-86
    Trial protocol
    		 IE  
    Global end of trial date
    04 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2026
    First version publication date
    07 Jan 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    COVIRL-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College Dublin
    Sponsor organisation address
    Belfield, Dublin, Ireland, Dublin 4
    Public contact
    UCD Clinical Research Center, University College Dublin, crc.monitoring@ucd.ie
    Scientific contact
    Centre for Experimental Pathogen Host Research, University College Dublin, cephr@ucd.ie
    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
    07 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the safety and efficacy of standard dose versus low dose tocilizumab in adults with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive decline in respiratory function and evolving systemic inflammation on time to intubation, non-invasive ventilation and/or all-cause mortality.
    Protection of trial subjects
    This trial was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. All subjects provided informed consent before undergoing any trial related procedures. The trial was reviewed and approved by the Competent Authorities and the local Research Ethics Committees (REC). An independent Data and Safety Monitoring Board (DSMB) was established to perform ongoing safety surveillance and to perform interim analyses on the study data. The DSMB acts as an independent committee, composed of a minimum of three members; at least two are clinicians not involved in the trial but with experience and expertise in clinical trials and / or biostatistics; at least one member is a clinician with expertise in infectious diseases. Administration of the IMP was given in a hospital setting with appropriate resuscitation facility and staff available in the event of an emergency.
    Background therapy
    		 Eligible participants will be randomised (1:1) to receive either standard of care alone or standard of care plus single dose (8mg/kg, maximum 800mg) intravenous tocilizumab infused over 60 minutes.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Apr 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
    Ireland: 76
    Worldwide total number of subjects
    76
    EEA total number of subjects
    76
    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)
    42
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started in Ireland in May 2020. 76 subjects were recruited, the first on 18/09/2020 and the last on 13/12/2021. A total of 75 were randomised (1 screen failure)

    Pre-assignment
    Screening details
    		 Study population comprised adults with PCR-confirmed COVID-19 infection requiring admission to hospital.

    Period 1
    Period 1 title
    Intention to Treat (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOC + TC
    Arm description
    		 Standard of Care + Tocilizumab 8mg/kg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    RoActemra
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Infusion
    Dosage and administration details
    After dilution, tocilizumab is administered as an intravenous infusion over 1 hour. In patients ≥ 30 kg tocilizumab should be diluted to a final volume of 100 mL with sterile, nonpyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique.

    Arm title
    		 Standard of care
    Arm description
    		 Standard of Care (SOC)
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		SOC + TC Standard of care
    Started
    38
    37
    Completed
    32
    26
    Not completed
    6
    11
         Adverse event, serious fatal
    5
    3
         Consent withdrawn by subject
    -
    2
         Transfer to another health facility
    -
    2
         Lost to follow-up
    1
    4
    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: Enrolled population includes all participants who formally consented to participate in the study, while the baseline period only consists of the ITT population (i.e. randomised)

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOC + TC
    Reporting group description
    		 Standard of Care + Tocilizumab 8mg/kg

    Reporting group title
    Standard of care
    Reporting group description
    		 Standard of Care (SOC)

    Reporting group values
    		 SOC + TC Standard of care Total
    Number of subjects
    		 38 37 75
    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
    Age
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 61.0 (50.6 to 70.7) 65.1 (53.8 to 72.0) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15 30
        Male
    		 23 22 45
    Race
    Units: Subjects
        White
    		 30 31 61
        Asian or Asian Irish
    		 5 3 8
        Black or Black Irish
    		 1 1 2
        Other
    		 2 1 3
        Not reported
    		 0 1 1
    Smoking status
    Units: Subjects
        Ex-smoker
    		 12 15 27
        Non-smoker
    		 24 21 45
        Unknown
    		 2 1 3
    Electrocardiogram results
    Units: Subjects
        Abnormal, clinically significant
    		 2 5 7
        Abnormal, not clinically significant
    		 7 7 14
        Within normal limits
    		 29 25 54
    Obesity
    Co-existing condition
    Units: Subjects
        Present
    		 18 20 38
        Absent
    		 20 17 37
    Diabetes without complications
    Co-existing conditions
    Units: Subjects
        Present
    		 7 9 16
        Absent
    		 31 28 59
    Chronic cardiac disease
    Co-existing condition
    Units: Subjects
        Present
    		 6 9 15
        Absent
    		 32 28 60
    BMI
    Body Mass Index
    Units: kg/cm^2
        median (inter-quartile range (Q1-Q3))
    		 30.4 (26.9 to 37.9) 31.4 (26.8 to 38.1) -
    Ferritin
    Units: microg/L
        median (inter-quartile range (Q1-Q3))
    		 1218 (794 to 2059) 1149 (576.5 to 1753) -
    Fibrinogen
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    		 4.93 (4.37 to 6.36) 5.50 (5.05 to 6.70) -
    Troponin T
    Units: ng/L
        median (inter-quartile range (Q1-Q3))
    		 6.00 (5.00 to 12.00) 8.00 (5.00 to 13.00) -
    D-dimer
    Units: microg FEU/mL
        median (inter-quartile range (Q1-Q3))
    		 0.85 (0.63 to 1.87) 1.11 (0.77 to 2.33) -
    C-Reactive Protein
    Units: mg/L
        median (inter-quartile range (Q1-Q3))
    		 116.3 (72.70 to 137.9) 139.6 (107.3 to 168.5) -
    Lactate dehydrogenase
    Units: U/L
        median (inter-quartile range (Q1-Q3))
    		 455.0 (387.0 to 497.0) 479.0 (408.5 to 582.5) -
    Interleukin-6
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    		 35.45 (7.30 to 85.50) 23.60 (11.60 to 53.70) -

    End points

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    End points reporting groups
    Reporting group title
    SOC + TC
    Reporting group description
    		 Standard of Care + Tocilizumab 8mg/kg

    Reporting group title
    Standard of care
    Reporting group description
    		 Standard of Care (SOC)

    Primary: Time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death

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    End point title
    		 Time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death
    End point description
    Time from randomisation to the first occurrence of any of the event: intubation and ventilation, non-invasive ventilation or death
    End point type
    Primary
    End point timeframe
    28 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: 1.0
    19
    11
    Attachments
    		 Untitled (Filename: eudract_surv.png)
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Kaplan-Meier methods with the log-rank test to compare treatment groups. Hazard ratios and 95% confidence intervals (CIs) were estimated using Cox proportional hazards models with treatment group and stratification for site as covariates.
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 3.97

    Secondary: Prevalence of new SAE at day 8

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    End point title
    		 Prevalence of new SAE at day 8
    End point description
    End point type
    Secondary
    End point timeframe
    8 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: Count
    22
    13
    Statistical analysis title
    		 Difference in proportion with new SAE at day 8
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Fisher exact
    Parameter type
    		 proportion
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death at 8 days

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    End point title
    		 Time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death at 8 days
    End point description
    Time from randomisation to the first occurrence of any of the event: intubation and ventilation, non-invasive ventilation or death at 8 days
    End point type
    Secondary
    End point timeframe
    8
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: 1.0
    17
    11
    Statistical analysis title
    		 Time to event analysis - Secondary endpoint
    Statistical analysis description
    Hazard ratios and 95% confidence intervals (CIs) were estimated using Cox proportional hazards models with treatment group and stratification for site as covariates.
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.182
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 3.59

    Secondary: Time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death at 14 days

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    End point title
    		 Time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death at 14 days
    End point description
    Time from randomisation to the first occurrence of any of the event: intubation and ventilation, non-invasive ventilation or death at 14 days
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: 1.0
    19
    11
    Statistical analysis title
    		 Time to event analysis - Secondary endpoint
    Statistical analysis description
    Hazard ratios and 95% confidence intervals (CIs) were estimated using Cox proportional hazards models with treatment group and stratification for site as covariates.
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.095
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 3.97

    Secondary: Survival at 8 days

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    End point title
    		 Survival at 8 days
    End point description
    Overall survival - time from randomisation to death. Any patients lost to follow-up or still alive at 8 days are censored
    End point type
    Secondary
    End point timeframe
    8 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: 1.0
    2
    2
    Statistical analysis title
    		 Time to event analysis - Secondary endpoint
    Statistical analysis description
    Hazard ratios and 95% confidence intervals (CIs) were estimated using Cox proportional hazards models with treatment group and stratification for site as covariates.
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.947
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 6.64

    Secondary: Survival at 14 days

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    End point title
    		 Survival at 14 days
    End point description
    Overall survival - time from randomisation to death. Any patients lost to follow-up or still alive at 14 days are censored
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: 1.0
    3
    2
    Statistical analysis title
    		 Time to event analysis - Secondary endpoint
    Statistical analysis description
    Hazard ratios and 95% confidence intervals (CIs) were estimated using Cox proportional hazards models with treatment group and stratification for site as covariates.
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.723
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 8.27

    Secondary: Survival at 28 days

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    End point title
    		 Survival at 28 days
    End point description
    Overall survival - time from randomisation to death. Any patients lost to follow-up or still alive at 28 days are censored
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: 1.0
    5
    2
    Statistical analysis title
    		 Time to event analysis - Secondary endpoint
    Statistical analysis description
    Hazard ratios and 95% confidence intervals (CIs) were estimated using Cox proportional hazards models with treatment group and stratification for site as covariates.
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.324
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 11.76

    Secondary: Incidence of intercurrent bacterial sepsis (positive blood culture) or septic shock (regardless of causative agent)

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    End point title
    		 Incidence of intercurrent bacterial sepsis (positive blood culture) or septic shock (regardless of causative agent)
    End point description
    End point type
    Secondary
    End point timeframe
    Overall (28 days)
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    38
    37
    Units: 1.0
        Present
    1
    2
    Statistical analysis title
    		 Incidence of intercurrent bacterial sepsis/septic
    Comparison groups
    Standard of care v SOC + TC
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.61
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Change from baseline in C-Reactive Protein (mg/L) at 8 days

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    End point title
    		 Change from baseline in C-Reactive Protein (mg/L) at 8 days
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline in C-Reactive Protein (mg/L) to 8 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    28
    26
    Units: mg/L
        least squares mean (confidence interval 95%)
    -117.61 (-132.23 to -103.46)
    -91.97 (-106.71 to -77.23)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -25.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -43.12
         upper limit
    		 -8.18

    Secondary: Change from baseline in C-Reactive Protein (mg/L) at 14 days

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    End point title
    		 Change from baseline in C-Reactive Protein (mg/L) at 14 days
    End point description
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    29
    25
    Units: mg/L
        least squares mean (confidence interval 95%)
    -113.61 (-132.23 to -94.09)
    -78.48 (-98.94 to -58.01)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -35.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -59.37
         upper limit
    		 -10.89

    Secondary: Change from baseline in C-Reactive Protein (mg/L) at 28 days

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    End point title
    		 Change from baseline in C-Reactive Protein (mg/L) at 28 days
    End point description
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    30
    22
    Units: mg/L
        least squares mean (confidence interval 95%)
    -106.69 (-126.21 to -87.18)
    -101.89 (-124.22 to -79.56)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.2
         upper limit
    		 21.59

    Secondary: Change from baseline in Ferritin (microg/L) at 8 days

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    End point title
    		 Change from baseline in Ferritin (microg/L) at 8 days
    End point description
    End point type
    Secondary
    End point timeframe
    8 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    25
    24
    Units: microg/L
        least squares mean (confidence interval 95%)
    -639.92 (-1157.62 to -122.21)
    -851.96 (-1368.53 to -335.39)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    212.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -445.43
         upper limit
    		 869.53

    Secondary: Change from baseline in Ferritin (microg/L) at 14 days

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    End point title
    		 Change from baseline in Ferritin (microg/L) at 14 days
    End point description
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    23
    23
    Units: microg/L
        least squares mean (confidence interval 95%)
    -1190.76 (-1457.05 to -924.47)
    -1271.51 (-1551.83 to -991.19)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    80.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -275.72
         upper limit
    		 437.22

    Secondary: Change from baseline in Ferritin (microg/L) at 28 days

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    End point title
    		 Change from baseline in Ferritin (microg/L) at 28 days
    End point description
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    26
    21
    Units: microg/L
        least squares mean (confidence interval 95%)
    -1238.51 (-1444.29 to -1032.74)
    -1092.01 (-13209.91 to -863.1)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -146.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -421.41
         upper limit
    		 128.39

    Secondary: Change from baseline in D-dimer (microg FEU/ml) at 8 days

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    End point title
    		 Change from baseline in D-dimer (microg FEU/ml) at 8 days
    End point description
    End point type
    Secondary
    End point timeframe
    8 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    20
    21
    Units: microg FEU/ml
        least squares mean (confidence interval 95%)
    0.13 (-0.88 to 1.14)
    0.15 (-0.85 to 1.15)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.33
         upper limit
    		 1.29

    Secondary: Change from baseline in D-dimer (microg FEU/ml) at 14 days

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    End point title
    		 Change from baseline in D-dimer (microg FEU/ml) at 14 days
    End point description
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    19
    20
    Units: microg FEU/ml
        least squares mean (confidence interval 95%)
    -0.9 (-1.24 to -0.56)
    -0.65 (-1.01 to -0.28)
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 0.22

    Secondary: Change from baseline in D-dimer (microg FEU/ml) at 28 days

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    End point title
    		 Change from baseline in D-dimer (microg FEU/ml) at 28 days
    End point description
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    21
    18
    Units: microg FEU/ml
        least squares mean (confidence interval 95%)
    -0.79 (-1.51 to -0.07)
    -0.7 (-1.46 to 0.08)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.06
         upper limit
    		 0.87

    Secondary: Change from baseline in Lactate dehydrogenase (U/L) at 8 days

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    End point title
    		 Change from baseline in Lactate dehydrogenase (U/L) at 8 days
    End point description
    End point type
    Secondary
    End point timeframe
    8 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    25
    20
    Units: U/L
        least squares mean (confidence interval 95%)
    -136.07 (-202.47 to -69.67)
    -115.21 (-187.5 to -42.92)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -20.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -108.26
         upper limit
    		 66.53

    Secondary: Change from baseline in Lactate dehydrogenase (U/L) at 14 days

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    End point title
    		 Change from baseline in Lactate dehydrogenase (U/L) at 14 days
    End point description
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    22
    24
    Units: U/L
        least squares mean (confidence interval 95%)
    -202.62 (-234.53 to -170.72)
    -209.61 (-241.39 to -177.83)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.16
         upper limit
    		 47.13

    Secondary: Change from baseline in Lactate dehydrogenase (U/L) at 28 days

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    End point title
    		 Change from baseline in Lactate dehydrogenase (U/L) at 28 days
    End point description
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    25
    18
    Units: U/L
        least squares mean (confidence interval 95%)
    -229.97 (-265.52 to -194.41)
    -240.21 (-279.21 to -201.21)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value and site as covariates
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.77
         upper limit
    		 58.25

    Secondary: Change from baseline in Interleukin - 6 (pg/ml) at 8 days

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    End point title
    		 Change from baseline in Interleukin - 6 (pg/ml) at 8 days
    End point description
    End point type
    Secondary
    End point timeframe
    8 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    14
    13
    Units: pg/ml
        least squares mean (confidence interval 95%)
    214.71 (38.01 to 391.41)
    -43.67 (-227.41 to 139.68)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    258.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 516.63

    Secondary: Change from baseline in Interleukin - 6 (pg/ml) at 14 days

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    End point title
    		 Change from baseline in Interleukin - 6 (pg/ml) at 14 days
    End point description
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    18
    15
    Units: pg/ml
        least squares mean (confidence interval 95%)
    232.12 (62.76 to 401.48)
    -33.84 (-219.58 to 151.89)
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    265.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.06
         upper limit
    		 518.87

    Secondary: Change from baseline in Interleukin - 6 (pg/ml) at 28 days

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    End point title
    		 Change from baseline in Interleukin - 6 (pg/ml) at 28 days
    End point description
    End point type
    Secondary
    End point timeframe
    28 days
    End point values
    		 SOC + TC Standard of care
    Number of subjects analysed
    20
    15
    Units: pg/ml
        least squares mean (confidence interval 95%)
    -4 (-47.62 to 39.62)
    -43.88 (-94.47 to 6.71)
    Statistical analysis title
    		 ANCOVA
    Statistical analysis description
    ANCOVA model with change from baseline as outcome and treatment, baseline value
    Comparison groups
    SOC + TC v Standard of care
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    39.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.9
         upper limit
    		 107.67

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the signing of Informed Consent up to 90 days after the last dose of the study drug has been received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    SOC + TC
    Reporting group description
    		 Standard of Care + Tocilizumab 8mg/kg

    Reporting group title
    Standard of Care
    Reporting group description
    		 Standard of Care (SOC)

    Serious adverse events
    		 SOC + TC Standard of Care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 38 (63.16%)
    15 / 37 (40.54%)
         number of deaths (all causes)
    5
    2
         number of deaths resulting from adverse events
    5
    2
    Vascular disorders
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Mechanical ventilation
         subjects affected / exposed
    19 / 38 (50.00%)
    10 / 37 (27.03%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Intensive care
         subjects affected / exposed
    11 / 38 (28.95%)
    6 / 37 (16.22%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Hospitalisation
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumopericardium
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (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
    Cerebral infarction
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Seizure like phenomena
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 37 (8.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (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 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspergillus infection
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 37 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 37 (2.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOC + TC Standard of Care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 38 (60.53%)
    16 / 37 (43.24%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 38 (7.89%)
    3 / 37 (8.11%)
         occurrences all number
    3
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 37 (2.70%)
         occurrences all number
    3
    1
    Chest X-ray abnormal
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 37 (5.41%)
         occurrences all number
    2
    2
    Lipids abnormal
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 37 (5.41%)
         occurrences all number
    2
    2
    Transaminases increased
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 37 (2.70%)
         occurrences all number
    3
    1
    Liver function test abnormal
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    3
    1
    Blood cholesterol increased
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Liver function test increased
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Troponin increased
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Surgical and medical procedures
    Mechanical ventilation
         subjects affected / exposed
    21 / 38 (55.26%)
    10 / 37 (27.03%)
         occurrences all number
    23
    10
    Intensive care
         subjects affected / exposed
    11 / 38 (28.95%)
    6 / 37 (16.22%)
         occurrences all number
    11
    6
    Hospitalisation
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 37 (5.41%)
         occurrences all number
    1
    2
    Bradycardia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 37 (8.11%)
         occurrences all number
    1
    3
    Fatigue
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 37 (2.70%)
         occurrences all number
    3
    1
    Mouth ulceration
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 37 (8.11%)
         occurrences all number
    4
    3
    Dyspnoea
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Haemoptysis
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2
    Hypoxia
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 37 (0.00%)
         occurrences all number
    2
    0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    5 / 38 (13.16%)
    0 / 37 (0.00%)
         occurrences all number
    5
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 38 (0.00%)
    4 / 37 (10.81%)
         occurrences all number
    0
    4
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    4 / 38 (10.53%)
    2 / 37 (5.41%)
         occurrences all number
    6
    2
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    2 / 38 (5.26%)
    2 / 37 (5.41%)
         occurrences all number
    2
    6
    Hyperglycaemia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Hyponatraemia
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 37 (2.70%)
         occurrences all number
    2
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 37 (5.41%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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 trial planned for two phases completed only Phase 1. It was terminated prematurely, in line with the advice from the Data Safety Monitoring Board, resulting in a smaller sample size that limits power and interpretation.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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