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    Clinical Trial Results:
    A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

    Summary
    EudraCT number
    		 2020-001497-30
    Trial protocol
    		 GB   FR   DE   ES   IT  
    Global end of trial date
    08 Apr 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Jun 2022
    First version publication date
    22 Apr 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    ALXN1210-COV-305
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04369469
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals, Inc.
    Sponsor organisation address
    121 Seaport Boulevard, Boston, MA, United States, 02210
    Public contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 15, clinicaltrials.eu@alexion.com
    Scientific contact
    European Clinical Trial Information, Alexion Europe SAS, +33 1 47 10 06 15, clinicaltrials.eu@alexion.com
    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
    08 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect of ravulizumab + best supportive care (BSC) compared with BSC alone on the survival of participants with acute respiratory distress syndrome due to coronavirus disease 2019 (COVID-19).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of Good Clinical Practice, according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonized Tripartite Guideline, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 Best supportive care
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 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
    Japan: 4
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 152
    Worldwide total number of subjects
    202
    EEA total number of subjects
    37
    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)
    95
    From 65 to 84 years
    104
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 210 participants screened, 8 (3.8%) participants were screen failures. A total of 202 participants were randomized and treated.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 - Ravulizumab + BSC
    Arm description
    		 Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ALXN1210
    Investigational medicinal product code
    Other name
    Ultomiris, Ravulizumab
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants randomized to ravulizumab + BSC received a weight-based dose of ravulizumab on Day 1, followed by weight-based doses of 600 milligrams (mg) or 900 mg ravulizumab on Days 5 and 10, and thereafter a single dose of 900 mg ravulizumab on Day 15. No additional doses were allowed during the Primary Evaluation Period (Day 1 through Day 29).

    Arm title
    		 Group 2 - BSC alone
    Arm description
    		 Participants received medications, therapies, and interventions per standard hospital treatment protocols.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group 1 - Ravulizumab + BSC Group 2 - BSC alone
    Started
    135
    67
    Intent to Treat (ITT) Population
    135
    66
    Pharmacokinetic (PK)
    127
    52 [1]
    Safety Population
    127
    67
    Completed
    125
    58
    Not completed
    10
    9
         Not qualified due to anaphylaxis
    1
    -
         Physician decision
    2
    1
         Consent withdrawn by subject
    2
    3
         Adverse event
    1
    -
         Unable to provide consent
    -
    1
         Did not meet inclusion/exclusion criteria
    2
    -
         Lost to follow-up
    2
    4
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The data reported in the intermediate milestones is applicable to the number of participants in the respective populations. The PK population is smaller than the number of subjects in the arm because fewer patients contributed samples.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 - Ravulizumab + BSC
    Reporting group description
    		 Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Reporting group title
    Group 2 - BSC alone
    Reporting group description
    		 Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Reporting group values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC alone Total
    Number of subjects
    		 135 67 202
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 63 32 95
        From 65-84 years
    		 71 33 104
        85 years and over
    		 1 2 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.2 ± 13.23 63.0 ± 12.79 -
    Gender categorical
    Units: Subjects
        Female
    		 39 23 62
        Male
    		 96 44 140
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 100 47 147
        Hispanic or Latino
    		 27 11 38
        Missing/Unknown
    		 7 5 12
        Not reported
    		 1 4 5
    Race
    Units: Subjects
        White
    		 72 40 112
        Black or African American
    		 20 7 27
        Missing/Unknown
    		 17 5 22
        Other
    		 12 5 17
        Asian
    		 9 7 16
        Not Reported
    		 4 2 6
        American Indian or Alaska Native
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
    Subject analysis sets

    Subject analysis set title
    Group 1 - Ravulizumab + BSC
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Subject analysis set title
    Group 2 - BSC Alone
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Subject analysis sets values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects
    135
    66
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    63
    31
        From 65-84 years
    71
    33
        85 years and over
    1
    2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.2 ± 13.23
    63.5 ± 12.40
    Gender categorical
    Units: Subjects
        Female
    39
    23
        Male
    96
    43
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    100
    46
        Hispanic or Latino
    27
    11
        Missing/Unknown
    7
    5
        Not reported
    1
    4
    Race
    Units: Subjects
        White
    72
    40
        Black or African American
    20
    7
        Missing/Unknown
    17
    5
        Other
    12
    5
        Asian
    9
    6
        Not Reported
    4
    2
        American Indian or Alaska Native
    1
    0
        Native Hawaiian or Other Pacific Islander
    0
    1

    End points

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    End points reporting groups
    Reporting group title
    Group 1 - Ravulizumab + BSC
    Reporting group description
    		 Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Reporting group title
    Group 2 - BSC alone
    Reporting group description
    		 Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Subject analysis set title
    Group 1 - Ravulizumab + BSC
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Subject analysis set title
    Group 2 - BSC Alone
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Primary: Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29

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    End point title
    		 Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29
    End point description
    Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations. The ITT Population consisted of all randomized participants. Participants were analyzed as randomized.
    End point type
    Primary
    End point timeframe
    Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    135
    66
    Units: Percentage of participants
        number (not applicable)
    57.6
    59.7
    Statistical analysis title
    		 Survival (Based On All-Cause Mortality) At Day 29
    Comparison groups
    Group 1 - Ravulizumab + BSC v Group 2 - BSC Alone
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6059 [1]
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -0.0205
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1703
         upper limit
    		 0.1293
    Notes
    [1] - One-sided Mantel-Haenszel test of the difference in two proportions stratified by intubated or not intubated on Day 1 and a family-wise Type I error of 0.025.

    Secondary: Number Of Days Free Of Mechanical Ventilation At Day 29

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    End point title
    		 Number Of Days Free Of Mechanical Ventilation At Day 29
    End point description
    The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation. The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    129
    62
    Units: Days
    least squares mean (confidence interval 95%)
        Overall
    6.79 (4.79 to 8.80)
    6.81 (4.19 to 9.43)
    No statistical analyses for this end point

    Secondary: Number of Days the Participants were Alive and Not in ICU

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    End point title
    		 Number of Days the Participants were Alive and Not in ICU
    End point description
    The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented. The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    129
    62
    Units: Days
    least squares mean (confidence interval 95%)
        Overall
    6.09 (4.31 to 7.87)
    6.71 (4.38 to 9.03)
    No statistical analyses for this end point

    Secondary: Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29

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    End point title
    		 Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29
    End point description
    Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition. The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    42
    17
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -2.0 ± 6.25
    -4.5 ± 4.90
    No statistical analyses for this end point

    Secondary: Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29

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    End point title
    		 Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29
    End point description
    Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point. The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    38
    17
    Units: ratio
        arithmetic mean (standard deviation)
    62.5 ± 112.43
    134.0 ± 104.35
    No statistical analyses for this end point

    Secondary: Number of Days the Participants were Alive and Not in the Hospital

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    End point title
    		 Number of Days the Participants were Alive and Not in the Hospital
    End point description
    The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented. The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Day 1 through Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    129
    62
    Units: Days
        least squares mean (confidence interval 95%)
    3.02 (1.76 to 4.29)
    3.47 (1.83 to 5.12)
    No statistical analyses for this end point

    Secondary: Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90

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    End point title
    		 Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90
    End point description
    For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section. The ITT Population consisted of all randomized participants. Participants were analyzed as randomized. Here, “Number Analyzed” signifies those participants who were evaluable for the assessment at the specified time frame.
    End point type
    Secondary
    End point timeframe
    Up to Day 60 and Up to Day 90
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    135
    66
    Units: participants
        Day 60 (n=135, 66)
    60
    29
        Day 90 (n=133, 65)
    49
    20
    No statistical analyses for this end point

    Secondary: Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29

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    End point title
    		 Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29
    End point description
    Results are reported in micrograms/milliliter (μg/mL). Pharmacokinetics/Pharmacodynamics (PK/PD) Population: participants in the ITT population with at least 1 postdose PK or PD result.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC
    Number of subjects analysed
    126
    Units: μg/mL
    arithmetic mean (standard deviation)
        Day 1 (predose) (n=116)
    0.00 ± 0.00
        Day 29 (predose) (n=44)
    231.35 ± 149.741
    No statistical analyses for this end point

    Secondary: Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29

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    End point title
    		 Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29
    End point description
    PK/PD Population: participants in the ITT population with at least 1 postdose PK or PD result. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    43
    14
    Units: μg/mL
        arithmetic mean (standard deviation)
    -156.31 ± 61.599
    21.79 ± 67.918
    No statistical analyses for this end point

    Secondary: Change From Baseline In Terminal Complement Complex C5b-9 At Day 29

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    End point title
    		 Change From Baseline In Terminal Complement Complex C5b-9 At Day 29
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29
    End point values
    		 Group 1 - Ravulizumab + BSC Group 2 - BSC Alone
    Number of subjects analysed
    43
    14
    Units: ug/L
        arithmetic mean (standard deviation)
    -133.23 ± 202.070
    -277.21 ± 604.742
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 through Day 90
    Adverse event reporting additional description
    Data for All-Cause Mortality was collected for ITT Population (randomized participants; participants analyzed as randomized [N=135, 66]). Serious and Other (Not Including Serious) Adverse Events were collected for Safety Population (randomized participants who received at least 1 dose of study drug; participants analyzed as treated [N=127, 67]).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Group 2 - BSC alone
    Reporting group description
    		 Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Reporting group title
    Group 1 - Ravulizumab + BSC
    Reporting group description
    		 Ravulizumab: Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15. BSC: Participants received medications, therapies, and interventions per standard hospital treatment protocols.

    Serious adverse events
    		 Group 2 - BSC alone Group 1 - Ravulizumab + BSC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 67 (56.72%)
    79 / 127 (62.20%)
         number of deaths (all causes)
    66
    55
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal cancer
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 127 (2.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (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
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    6 / 67 (8.96%)
    14 / 127 (11.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 14
         deaths causally related to treatment / all
    0 / 6
    0 / 11
    Condition aggravated
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    5 / 67 (7.46%)
    12 / 127 (9.45%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 4
    0 / 10
    Acute respiratory failure
         subjects affected / exposed
    4 / 67 (5.97%)
    6 / 127 (4.72%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Respiratory failure
         subjects affected / exposed
    5 / 67 (7.46%)
    5 / 127 (3.94%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Hypoxia
         subjects affected / exposed
    3 / 67 (4.48%)
    4 / 127 (3.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pneumothorax
         subjects affected / exposed
    2 / 67 (2.99%)
    4 / 127 (3.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 127 (2.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumomediastinum
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood beta-D-glucan positive
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood lactic acid increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    2 / 67 (2.99%)
    4 / 127 (3.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Atrial fibrillation
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiogenic shock
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain injury
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intensive care unit acquired weakness
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microangiopathic haemolytic anaemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ischaemia
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    2 / 67 (2.99%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haematoma muscle
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Septic shock
         subjects affected / exposed
    3 / 67 (4.48%)
    13 / 127 (10.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 8
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 67 (0.00%)
    7 / 127 (5.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 7
    Pneumonia
         subjects affected / exposed
    1 / 67 (1.49%)
    4 / 127 (3.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Sepsis
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 127 (2.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia bacterial
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 127 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Candida infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 127 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptococcosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter pneumonia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal sepsis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Herpes simplex pneumonia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Metabolic acidosis
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 127 (0.79%)
         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
    		 Group 2 - BSC alone Group 1 - Ravulizumab + BSC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 67 (73.13%)
    97 / 127 (76.38%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    8 / 67 (11.94%)
    16 / 127 (12.60%)
         occurrences all number
    10
    18
    Deep vein thrombosis
         subjects affected / exposed
    2 / 67 (2.99%)
    14 / 127 (11.02%)
         occurrences all number
    2
    14
    Hypertension
         subjects affected / exposed
    3 / 67 (4.48%)
    9 / 127 (7.09%)
         occurrences all number
    3
    9
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    5 / 67 (7.46%)
    12 / 127 (9.45%)
         occurrences all number
    5
    12
    Bradycardia
         subjects affected / exposed
    4 / 67 (5.97%)
    6 / 127 (4.72%)
         occurrences all number
    4
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 67 (5.97%)
    13 / 127 (10.24%)
         occurrences all number
    5
    15
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 67 (8.96%)
    10 / 127 (7.87%)
         occurrences all number
    6
    12
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 67 (7.46%)
    5 / 127 (3.94%)
         occurrences all number
    6
    5
    Respiratory, thoracic and mediastinal disorders
    Lung disorder
         subjects affected / exposed
    4 / 67 (5.97%)
    1 / 127 (0.79%)
         occurrences all number
    6
    1
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    4 / 67 (5.97%)
    8 / 127 (6.30%)
         occurrences all number
    4
    9
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 67 (7.46%)
    9 / 127 (7.09%)
         occurrences all number
    5
    10
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    4 / 67 (5.97%)
    7 / 127 (5.51%)
         occurrences all number
    4
    7
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    6 / 67 (8.96%)
    8 / 127 (6.30%)
         occurrences all number
    6
    9
    Hypernatraemia
         subjects affected / exposed
    3 / 67 (4.48%)
    11 / 127 (8.66%)
         occurrences all number
    3
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2020
    - Clarified the informed consent process for participants who were unconscious and whose legally acceptable representative was not immediately available. - Appended Investigator guidance regarding the management of potential drug infusion reactions during ravulizumab administration.
    17 Apr 2020
    - Relocated “Survival (based on all-cause mortality) at Day 60 and Day 90” from the list of exploratory endpoints to the list of secondary endpoints. - Clarified that participants discharged from the hospital before the end of the Primary Evaluation Period would be contacted via telephone on Day 29 to determine health status (for example, survival, mechanical ventilation, hospitalization, intensive care unit, and dialysis). - Removed the definition of Full Analysis Set and added definition of Intent to Treat. - Revised analyses of selected endpoints.
    09 Jun 2020
    - Updated the inclusion and exclusion criteria, study endpoints and objectives, and the schedule of activities. Participant reported outcomes (Short Form 12 and EuroQol 5 Dimension 5 Level) were added and implemented change to align content in Section 9 (Statistical Considerations) with version 1 and version 2 of the statistical analysis plan.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Jan 2021
    Enrollment of participants was paused on 13-Jan-2021. At that time, 202 participants had been randomized. An interim analysis for efficacy and futility was conducted on data from the first 122 participants who completed the Primary Evaluation Period. The analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Enrollment of participants was paused on 13-Jan-2021. Subsequent analysis showed that the study met the prespecified stopping criteria for futility. After review of all participant data, Alexion terminated the study on 01-Sep-2021.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33826106
    http://www.ncbi.nlm.nih.gov/pubmed/32660611
    For support, Contact us.
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