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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) versus Placebo in Asymptomatic Ambulatory Outpatients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

    Summary
    EudraCT number
    		 2021-000269-34
    Trial protocol
    		 ES  
    Global end of trial date
    27 Dec 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2022
    First version publication date
    29 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GC2010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04847141
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grifols Therapeutics LLC
    Sponsor organisation address
    79 TW Alexander Drive, Research Triangle Park, NC, United States, 27709
    Public contact
    Mireia Torres, Instituto Grifols, S.A., mireia.torres@grifols.com
    Scientific contact
    Mireia Torres, Instituto Grifols, S.A., mireia.torres@grifols.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
    27 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of the study was to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (2 doses) versus placebo with regard to the percentage of asymptomatic subjects who remained asymptomatic, i.e., who did not develop symptomatic coronavirus disease 2019 (COVID-19) through Day 14 as per the protocol defined criteria.
    Protection of trial subjects
    All subjects were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2021
    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
    Spain: 465
    Worldwide total number of subjects
    465
    EEA total number of subjects
    465
    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)
    445
    From 65 to 84 years
    18
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects took part in the study at 5 centres in Spain, from 28 April 2021 (first subject enrolled to receive the study drug) to 27 December 2021 (last subject completed).

    Pre-assignment
    Screening details
    		 Subjects with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection were randomised in a 1:1:1 ratio to receive C19-IG 20% 1 gram (g), C19-IG 20% 2 g, and placebo. A total of 555 subjects were screened and 465 subjects were randomised in the study. Among these, 461 subjects were dosed, and 430 subjects completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 C19-IG 20% 1 g
    Arm description
    		 Subjects received 1 g of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 millilitres (mL) C19-IG 20% plus one syringe of 5 mL sterile 0.9% sodium chloride (NaCl) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    0.9% NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.9% NaCl 5 mL was administered via SC infusion.

    Investigational medicinal product name
    C19-IG 20%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 g of C19-IG 20% was administered via SC infusion.

    Arm title
    		 C19-IG 20% 2 g
    Arm description
    		 Subjects received 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    C19-IG 20%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    2 g of C19-IG 20% was administered via SC infusion.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% NaCl injection on Day 1.
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    C19-IG 20% matching placebo administered via SC infusion.

    Number of subjects in period 1 [1]
    		C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Started
    152
    153
    156
    Completed
    142
    143
    145
    Not completed
    10
    10
    11
         Adverse event, non-fatal
    1
    -
    1
         Withdrawal by Subject
    2
    4
    3
         Lost to follow-up
    7
    5
    7
         Reason not Specified
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 465 subjects were randomised of which 461 subjects were dosed.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    C19-IG 20% 1 g
    Reporting group description
    		 Subjects received 1 g of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 millilitres (mL) C19-IG 20% plus one syringe of 5 mL sterile 0.9% sodium chloride (NaCl) on Day 1.

    Reporting group title
    C19-IG 20% 2 g
    Reporting group description
    		 Subjects received 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% NaCl injection on Day 1.

    Reporting group values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo Total
    Number of subjects
    		 152 153 156 461
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.8 ( 12.76 ) 41.1 ( 12.40 ) 38.8 ( 13.33 ) -
    Gender categorical
    Units: Subjects
        Female
    		 66 62 69 197
        Male
    		 86 91 87 264
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 40 32 45 117
        Not Hispanic or Latino
    		 112 121 111 344
    Race
    Units: Subjects
        Asian
    		 1 0 3 4
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 1
        Black or African American
    		 4 6 3 13
        White
    		 138 140 140 418
        More than one race
    		 0 0 1 1
        Unknown or Not Reported
    		 9 6 9 24

    End points

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    End points reporting groups
    Reporting group title
    C19-IG 20% 1 g
    Reporting group description
    		 Subjects received 1 g of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 millilitres (mL) C19-IG 20% plus one syringe of 5 mL sterile 0.9% sodium chloride (NaCl) on Day 1.

    Reporting group title
    C19-IG 20% 2 g
    Reporting group description
    		 Subjects received 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% NaCl injection on Day 1.

    Primary: Percentage of Asymptomatic Subjects Who Remained Asymptomatic, i.e., Who did Not Develop Symptomatic COVID-19 Through Day 14

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    End point title
    		 Percentage of Asymptomatic Subjects Who Remained Asymptomatic, i.e., Who did Not Develop Symptomatic COVID-19 Through Day 14
    End point description
    Subjects were described as symptomatic if they a. experienced at least two of the following systemic symptoms: fever (≥38 ºC), chills, myalgia, headache, sore throat, cough, fatigue that interferes with activities of daily living, new olfactory/taste disorder(s), and vomiting/diarrhoea; b. experienced at least one of the following respiratory signs/symptoms: new or worsening shortness of breath or difficulty breathing; c. experienced a peripheral oxygen saturation by pulse oximetry (SpO2) <94% on room air; or d. had radiographical evidence of pneumonia. The percentage of subjects who meet the primary endpoint within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% confidence interval (CI). Intent-to-treat (ITT) population included all subjects who were randomised. Modified ITT (mITT) population included the subset of ITT subjects who were also dosed.
    End point type
    Primary
    End point timeframe
    Up to Day 14
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (confidence interval 95%)
    59.9 (51.6 to 67.7)
    64.7 (56.6 to 72.3)
    63.5 (55.4 to 71.0)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.5167 [2]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    -3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.6
         upper limit
    		 7.4
    Notes
    [1] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [2] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects meeting the primary efficacy endpoint between C19-IG 20% 1 g and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    Placebo v C19-IG 20% 2 g
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.8197 [4]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.6
         upper limit
    		 12
    Notes
    [3] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [4] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects meeting the primary efficacy endpoint between C19-IG 20% 2 g and placebo.

    Secondary: Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL)

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    End point title
    		 Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL)
    End point description
    Mean change from baseline (CFB) in log10 SARS-CoV-2 viral load at Days 7 and 14 was assessed. mITT population included the subset of ITT subjects who were also dosed. Here, "n" is the number of subjects with data available for analysis at the given time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 7 and Day 14
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: log10 copies/mL
    least squares mean (confidence interval 95%)
        CFB at Day 7 (n=143, 140, 147)
    -1.49 (-1.74 to -1.25)
    -1.76 (-2.01 to -1.51)
    -1.59 (-1.83 to -1.35)
        CFB at Day 14 (n=135, 134, 137)
    -2.80 (-2.97 to -2.64)
    -3.02 (-3.19 to -2.85)
    -2.91 (-3.08 to -2.75)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.5756
    Method
    		 ANCOVA
    Parameter type
    		 Least squares (LS) mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.44
    Notes
    [5] - 95% CI for the difference in the LS mean between 1 g C19-IG 20% dose group and placebo was calculated using the ANCOVA model, including change from baseline value as dependent variable; treatment group as fixed effect; and baseline viral load value, age, and gender as covariates.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.3289
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.17
    Notes
    [6] - 95% CI for the difference in the LS mean between 2 g C19-IG 20% dose group and placebo was calculated using the ANCOVA model, including change from baseline value as dependent variable; treatment group as fixed effect; and baseline viral load value, age, and gender as covariates.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.3418
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.34
    Notes
    [7] - 95% CI for the difference in the LS mean between 1 g C19-IG 20% dose group and placebo was calculated using the ANCOVA model, including change from baseline value as dependent variable; treatment group as fixed effect; and baseline viral load value, age, and gender as covariates.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.3688
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 0.13
    Notes
    [8] - 95% CI for the difference in the LS mean between 2 g C19-IG 20% dose group and placebo was calculated using the ANCOVA model, including change from baseline value as dependent variable; treatment group as fixed effect; and baseline viral load value, age, and gender as covariates.

    Secondary: Percentage of Subjects Who Remained in an Outpatient Setting and Maintained an SpO2 ≥94% on Room Air on Day 3, Day 7, and Day 14

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    End point title
    		 Percentage of Subjects Who Remained in an Outpatient Setting and Maintained an SpO2 ≥94% on Room Air on Day 3, Day 7, and Day 14
    End point description
    An outpatient setting was defined as no hospitalisation or intensive care unit (ICU) admission through Days 3, 7, and 14. The percentage of subjects who remained in an outpatient setting and maintained SpO2 ≥94% on room air at each timepoint within each treatment group were presented along with a two-sided exact (Clopper-Pearson) 95% CI. mITT population included the subset of ITT subjects who were also dosed. Here, "n" is the number of subjects with data available for analysis at given timepoint. p-value and 95% CI were not estimable for C19-IG 20% 1 g vs placebo as all subjects had remained in an outpatient setting and maintained SpO2 ≥94% on Room Air in C19-IG 20% 1 g and placebo arm on Day 3.
    End point type
    Secondary
    End point timeframe
    Day 3, Day 7, and Day 14
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 3 (n=151, 152, 156)
    100 (97.6 to 100)
    98.7 (95.3 to 99.8)
    100 (97.7 to 100)
        Day 7 (n=149, 151, 156)
    100 (97.6 to 100)
    96.7 (92.4 to 98.9)
    98.7 (95.5 to 99.8)
        Day 14 (n=148, 149, 154)
    95.3 (90.5 to 98.1)
    94.0 (88.8 to 97.2)
    96.1 (91.7 to 98.6)
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 3
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.1506 [10]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.7
         upper limit
    		 1.2
    Notes
    [9] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [10] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who remained in an outpatient setting & maintained SpO2≥94% between C19-IG 20% 2 g & placebo.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 = 0.1655 [12]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 4.6
    Notes
    [11] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [12] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who remained in an outpatient setting & maintained SpO2≥94% between C19-IG 20% 1 g & placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [13]
    P-value
    		 = 0.2337 [14]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 1.7
    Notes
    [13] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [14] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who remained in an outpatient setting & maintained SpO2≥94% between C19-IG 20% 2 g & placebo.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [15]
    P-value
    		 = 0.7212 [16]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 4.2
    Notes
    [15] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [16] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who remained in an outpatient setting & maintained SpO2≥94% between C19-IG 20% 1 g & placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.3897 [18]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 3.1
    Notes
    [17] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [18] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who remained in an outpatient setting & maintained SpO2≥94% between C19-IG 20% 2 g & placebo.

    Secondary: Percentage of Subjects Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) Test at Multiple Timepoints Through Day 14 and Through Day 29

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    End point title
    		 Percentage of Subjects Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) Test at Multiple Timepoints Through Day 14 and Through Day 29
    End point description
    The percentage of subjects with negative SARS-CoV-2 by PCR through Day 14 and Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. mITT population included the subset of ITT subjects who were also dosed. Here, "n" is the number of subjects with non-missing test results at the given visit.
    End point type
    Secondary
    End point timeframe
    Day 3, Day 7, Day 14, and Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 3 (n=148, 148, 154)
    29.1 (21.9 to 37.1)
    30.4 (23.1 to 38.5)
    26.0 (19.3 to 33.7)
        Day 7 (n=143, 141, 147)
    37.8 (29.8 to 46.3)
    44.0 (35.6 to 52.6)
    36.1 (28.3 to 44.4)
        Day 14 (n=135, 135, 137)
    65.2 (56.5 to 73.2)
    74.1 (65.8 to 81.2)
    67.2 (58.6 to 74.9)
        Day 29 (n=125, 127, 124)
    92.0 (85.8 to 96.1)
    89.0 (82.2 to 93.8)
    87.1 (79.9 to 92.4)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 3
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.5489 [20]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 13.3
    Notes
    [19] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [20] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 3
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [21]
    P-value
    		 = 0.392 [22]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 14.7
    Notes
    [21] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [22] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 2 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [23]
    P-value
    		 = 0.7632 [24]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 12.9
    Notes
    [23] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [24] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [25]
    P-value
    		 = 0.1702 [26]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 19.2
    Notes
    [25] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [26] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 2 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [27]
    P-value
    		 = 0.7316 [28]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.3
         upper limit
    		 9.4
    Notes
    [27] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [28] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [29]
    P-value
    		 = 0.2104 [30]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 18
    Notes
    [29] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [30] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 2 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 29
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [31]
    P-value
    		 = 0.2059 [32]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 13.2
    Notes
    [31] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [32] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 29
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [33]
    P-value
    		 = 0.6463 [34]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 10.3
    Notes
    [33] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [34] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who had a negative test result between C19-IG 20% 2 g dose group and placebo.

    Secondary: Time to Negative SARS-CoV-2 PCR From Baseline Through Day 29

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    End point title
    		 Time to Negative SARS-CoV-2 PCR From Baseline Through Day 29
    End point description
    The first negative test result was defined as the first PCR negative result after the first PCR positive result. Kaplan-Meier (KM) method was used for analysis. Subjects who did not have any viral load data or had negative test results through the study were excluded from the KM analysis. mITT population included the subset of ITT subjects who were also dosed. Here, “Subjects analysed” is the subjects who achieved negative test results through Day 29.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    101
    95
    112
    Units: days
        median (confidence interval 95%)
    14 (14 to 15)
    14 (14 to 15)
    14 (14 to 15)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9033
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5456
    Method
    		 Logrank
    Confidence interval

    Secondary: Percentage of Subjects Who Required Oxygen (O2) Supplementation on or Before Day 29

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    End point title
    		 Percentage of Subjects Who Required Oxygen (O2) Supplementation on or Before Day 29
    End point description
    The percentage of subjects requiring oxygen supplementation through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. mITT population included the subset of ITT subjects who were also dosed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (confidence interval 95%)
    2.0 (0.4 to 5.7)
    3.9 (1.5 to 8.3)
    1.3 (0.2 to 4.6)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [35]
    P-value
    		 = 0.6311 [36]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 4.6
    Notes
    [35] - 95% CI for percentage difference between each of 1 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.
    [36] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required oxygen supplementation between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [37]
    P-value
    		 = 0.1441 [38]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 7.3
    Notes
    [37] - 95% CI for percentage difference between each of 2 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.
    [38] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required oxygen supplementation between C19-IG 20% 2 g dose group and placebo.

    Secondary: Duration of Any Oxygen Use Through Day 29

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    End point title
    		 Duration of Any Oxygen Use Through Day 29
    End point description
    The duration (number of days) of any oxygen use from Day 1 through Day 29 was calculated based on the start/stop date of using oxygen supplementation. mITT population included the subset of ITT subjects who were also dosed. Here, “Subjects analysed” is the number of subjects who required oxygen supplementation.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    3
    5
    2
    Units: days
        median (full range (min-max))
    7.0 (6 to 9)
    7.0 (2 to 8)
    9.5 (4 to 15)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    5
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [39]
    P-value
    		 = 0.8555
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.27
    Notes
    [39] - 95% CI for difference in LS mean between 1 g C19-IG 20% and placebo was calculated using an ANCOVA model, with number of days on oxygen as dependent variable and treatment group as fixed effect, adjusting for baseline characteristics (including age and gender).
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [40]
    P-value
    		 = 0.8108
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.28
    Notes
    [40] - 95% CI for difference in LS mean between 2 g C19-IG 20% and placebo was calculated using an ANCOVA model, with number of days on oxygen as dependent variable and treatment group as fixed effect, adjusting for baseline characteristics (including age and gender).

    Secondary: Absolute Value Score on a 7-point Ordinal Scale

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    End point title
    		 Absolute Value Score on a 7-point Ordinal Scale
    End point description
    The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status of a subject based on the following points: 1) death; 2) hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) hospitalised, on non-invasive ventilation or high flow oxygen devices; 4) hospitalised, requiring supplemental oxygen; 5) hospitalised, not requiring supplemental oxygen; 6) not hospitalised, limitation on activities; and 7) not hospitalised, no limitations on activities. A higher score indicates less severity. mITT population included the subset of ITT subjects who were also dosed. Here, "n" is the number of subjects with data available at the given time point.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 7, 14, and 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline [n=152, 153, 156]
    7.0 ( 0.00 )
    7.0 ( 0.08 )
    7.0 ( 0.08 )
        Day 7 (n=148, 147, 154)
    7.0 ( 0.08 )
    7.0 ( 0.16 )
    7.0 ( 0.19 )
        Day 14 (n=146, 148, 146)
    7.0 ( 0.32 )
    6.9 ( 0.48 )
    7.0 ( 0.08 )
        Day 29 (n=142, 144, 145)
    7.0 ( 0.20 )
    7.0 ( 0.14 )
    7.0 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Mean Change From Baseline in the 7-point Ordinal Scale

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    End point title
    		 Mean Change From Baseline in the 7-point Ordinal Scale
    End point description
    The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status of a subject based on the following points: 1) death; 2) hospitalised, on invasive mechanical ventilation or ECMO; 3) hospitalised, on non-invasive ventilation or high flow oxygen devices; 4) hospitalised, requiring supplemental oxygen; 5) hospitalised, not requiring supplemental oxygen; 6) not hospitalised, limitation on activities; and 7) not hospitalised, no limitations on activities. A higher score indicates less severity. The analysis was performed by using a linear mixed-effects model for repeated measures (MMRM). mITT population included the subset of ITT subjects who were also dosed. Here, "n" is the number of subjects with data available at the given time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 7, Day 14, and Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: score on a scale
    least squares mean (confidence interval 95%)
        CFB at Day 7 (n=148, 147, 154)
    -0.00 (-0.03 to 0.02)
    -0.02 (-0.05 to 0.00)
    -0.04 (-0.06 to -0.01)
        CFB at Day 14 (n=146, 148, 146)
    -0.05 (-0.11 to 0.00)
    -0.07 (-0.12 to -0.01)
    -0.00 (-0.06 to 0.05)
        CFB at Day 29 (n=142, 144, 145)
    -0.04 (-0.06 to -0.01)
    -0.02 (-0.04 to 0.01)
    -0.00 (-0.03 to 0.03)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    Placebo v C19-IG 20% 1 g
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [41]
    P-value
    		 = 0.0692 [42]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.07
    Notes
    [41] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [42] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [43]
    P-value
    		 = 0.4956 [44]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.05
    Notes
    [43] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [44] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [45]
    P-value
    		 = 0.22 [46]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.03
    Notes
    [45] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [46] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [47]
    P-value
    		 = 0.0906 [48]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    -0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.14
         upper limit
    		 0.01
    Notes
    [47] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [48] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 29
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [49]
    P-value
    		 = 0.0439 [50]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0
    Notes
    [49] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [50] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 29
    Comparison groups
    Placebo v C19-IG 20% 2 g
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [51]
    P-value
    		 = 0.4128 [52]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.02
    Notes
    [51] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [52] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.

    Secondary: Percentage of Subjects in Each Severity Category of the 7-point Ordinal Scale

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    End point title
    		 Percentage of Subjects in Each Severity Category of the 7-point Ordinal Scale
    End point description
    The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status of a subject based on the following points: 1) death; 2) hospitalised, on invasive mechanical ventilation or ECMO; 3) hospitalised, on non-invasive ventilation or high flow oxygen devices; 4) hospitalised, requiring supplemental oxygen; 5) hospitalised, not requiring supplemental oxygen; 6) not hospitalised, limitation on activities; and 7) not hospitalised, no limitations on activities. mITT population included the subset of ITT subjects who were also dosed. Here, "n" is the number of subjects with data available at the given time point in each treatment group. The percentage values are rounded off to the nearest decimal point.
    End point type
    Secondary
    End point timeframe
    Days 1, 7, 14, and 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
    number (not applicable)
        Day 1: 1 (n=152, 153, 156)
    0.0
    0.0
    0.0
        Day 1: 2 (n=152, 153, 156)
    0.0
    0.0
    0.0
        Day 1: 3 (n=152, 153, 156)
    0.0
    0.0
    0.0
        Day 1: 4 (n=152, 153, 156)
    0.0
    0.0
    0.0
        Day 1: 5 (n=152, 153, 156)
    0.0
    0.0
    0.0
        Day 1: 6 (n=152, 153, 156)
    0.0
    0.7
    0.6
        Day 1: 7 (n=152, 153, 156)
    100
    99.3
    99.4
        Day 7: 1 (n=148, 147, 154)
    0.0
    0.0
    0.0
        Day 7: 2 (n=148, 147, 154)
    0.0
    0.0
    0.0
        Day 7: 3 (n=148, 147, 154)
    0.0
    0.0
    0.0
        Day 7: 4 (n=148, 147, 154)
    0.0
    0.0
    0.0
        Day 7: 5 (n=148, 147, 154)
    0.0
    0.0
    0.0
        Day 7: 6 (n=148, 147, 154)
    0.7
    2.7
    3.9
        Day 7: 7 (n=148, 147, 154)
    99.3
    97.3
    96.1
        Day 14: 1 (n=146, 148, 146)
    0.0
    0.0
    0.0
        Day 14: 2 (n=146, 148, 146)
    0.0
    0.0
    0.0
        Day 14: 3 (n=146, 148, 146)
    0.0
    1.4
    0.0
        Day 14: 4 (n=146, 148, 146)
    0.7
    0.0
    0.0
        Day 14: 5 (n=146, 148, 146)
    0.7
    0.0
    0.0
        Day 14: 6 (n=146, 148, 146)
    1.4
    2.0
    0.7
        Day 14: 7 (n=146, 148, 146)
    97.3
    96.6
    99.3
        Day 29: 1 (n=142, 144, 145)
    0.0
    0.0
    0.0
        Day 29: 2 (n=142, 144, 145)
    0.0
    0.0
    0.0
        Day 29: 3 (n=142, 144, 145)
    0.0
    0.0
    0.0
        Day 29: 4 (n=142, 144, 145)
    0.0
    0.0
    0.0
        Day 29: 5 (n=142, 144, 145)
    0.0
    0.0
    0.0
        Day 29: 6 (n=142, 144, 145)
    4.2
    2.1
    0.7
        Day 29: 7 (n=142, 144, 145)
    95.8
    97.9
    99.3
    No statistical analyses for this end point

    Secondary: Change From Baseline in National Early Warning Score (NEWS)

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    End point title
    		 Change From Baseline in National Early Warning Score (NEWS)
    End point description
    The NEWS has demonstrated an ability to classify subjects at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate,oxygen saturation,any supplemental oxygen,temperature,systolic blood pressure (BP),heart rate,level of consciousness [Alert,Voice,Pain,Unresponsive]). A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 or 2) and level of consciousness (score of 0 [alert,normal health condition] or 3 [altered mental state/confusion,worst health condition]). All parameter scores were summed to get an aggregate NEWS assessment. Scoring for NEWS ranges from 0 to 20,with higher scores meaning more severity/higher clinical risk: low risk (score 1 to 4);medium risk (score 5 to 6);high risk (score 7 to 20). The analysis is performed by using a linear MMRM. mITT population included the subset of ITT subjects who were also dosed. Here,"n" is the number of subjects with a non-missing NEWS total score at the given time point.
    End point type
    Secondary
    End point timeframe
    Baseline to Day 7, Day 14, and Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: score on a scale
    least squares mean (confidence interval 95%)
        CFB at Day 7 (n=137, 138, 146)
    0.70 (0.50 to 0.90)
    0.78 (0.58 to 0.98)
    0.70 (0.51 to 0.90)
        CFB at Day 14 (n=132, 134, 138)
    0.68 (0.49 to 0.87)
    0.65 (0.46 to 0.84)
    0.67 (0.48 to 0.86)
        CFB at Day 29 (n=121, 123, 121)
    0.61 (0.43 to 0.79)
    0.59 (0.40 to 0.77)
    0.46 (0.27 to 0.64)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [53]
    P-value
    		 = 0.9713 [54]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.27
    Notes
    [53] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [54] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 7
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [55]
    P-value
    		 = 0.5985 [56]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.35
    Notes
    [55] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [56] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [57]
    P-value
    		 = 0.9209 [58]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.28
    Notes
    [57] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [58] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 14
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [59]
    P-value
    		 = 0.9181 [60]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.25
    Notes
    [59] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [60] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Statistical analysis description
    Day 29
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [61]
    P-value
    		 = 0.2443 [62]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.41
    Notes
    [61] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [62] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Statistical analysis description
    Day 29
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [63]
    P-value
    		 = 0.3233 [64]
    Method
    		 Kenward-Roger
    Parameter type
    		 LS mean difference
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.13
         upper limit
    		 0.39
    Notes
    [63] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.
    [64] - p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.

    Secondary: Percentage of Subjects Who Required At Least One COVID-19 Related Medically Attended Visit (MAV) for Management/Treatment of COVID-19 Which May Have Occurred in Any Setting Through Day 29

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    End point title
    		 Percentage of Subjects Who Required At Least One COVID-19 Related Medically Attended Visit (MAV) for Management/Treatment of COVID-19 Which May Have Occurred in Any Setting Through Day 29
    End point description
    MAV for management/treatment of COVID-19 may have occurred in any setting e.g., emergency department, urgent care, outpatient clinic, or professional setting wherein direct in-person/telemedicine medical assessment and escalation of care for COVID-19 was provided by licensed healthcare personnel. The percentage of subjects requiring at least one COVID-19-related MAV for management/treatment of COVID-19 (apart from routinely scheduled study-directed visits) within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. mITT population included the subset of ITT subjects who were also dosed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (confidence interval 95%)
    17.1 (11.5 to 24.0)
    19.0 (13.1 to 26.1)
    14.1 (9.1 to 20.6)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [65]
    P-value
    		 = 0.4676 [66]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 11.5
    Notes
    [65] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [66] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required at least 1 COVID-19 related MAV between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [67]
    P-value
    		 = 0.2507 [68]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 13.4
    Notes
    [67] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [68] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required at least 1 COVID-19 related MAV between C19-IG 20% 2 g dose group and placebo.

    Secondary: Percentage of Subjects Who Required Hospital Admission for Medical Care (Non-Quarantine Purposes) Through Day 29

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    End point title
    		 Percentage of Subjects Who Required Hospital Admission for Medical Care (Non-Quarantine Purposes) Through Day 29
    End point description
    The percentage of subjects requiring hospital admission through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. mITT population included the subset of ITT subjects who were also dosed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (confidence interval 95%)
    2.0 (0.4 to 5.7)
    4.6 (1.9 to 9.2)
    1.9 (0.4 to 5.5)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [69]
    P-value
    		 = 0.9744 [70]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.8
         upper limit
    		 4
    Notes
    [69] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [70] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required hospital admission between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [71]
    P-value
    		 = 0.1878 [72]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 7.5
    Notes
    [71] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [72] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required hospital admission between C19-IG 20% 2 g dose group and placebo.

    Secondary: Duration of Hospital Stay Through Day 29

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    End point title
    		 Duration of Hospital Stay Through Day 29
    End point description
    The duration (number of days) of hospitalisation from post-randomisation through Day 29 was calculated based on hospital admission and discharge dates recorded. mITT population included the subset of ITT subjects who were also dosed. Here, "Subjects analysed" is the number of subjects who were hospitalised.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    3
    7
    3
    Units: days
        median (full range (min-max))
    9.0 (6 to 18)
    10.0 (3 to 15)
    9.0 (8 to 15)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    6
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [73]
    P-value
    		 = 0.9485
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.4
    Notes
    [73] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable & treatment group as fixed effect, adjusting for baseline.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [74]
    P-value
    		 = 0.4734
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.54
    Notes
    [74] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable & treatment group as fixed effect, adjusting for baseline.

    Secondary: Percentage of Subjects Who Required Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care Through Day 29

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    End point title
    		 Percentage of Subjects Who Required Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care Through Day 29
    End point description
    The percentage of subjects requiring ICU admission through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. ICU level care is defined as the medical need for intensive or invasive monitoring; the immediate or impending need for the support of the airway, breathing, or circulation; and/or stabilisation of acute severe, or life-threatening complications of COVID-19. mITT population included the subset of ITT subjects who were also dosed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (confidence interval 95%)
    0.66 (0.02 to 3.61)
    0.65 (0.02 to 3.59)
    0.64 (0.02 to 3.52)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    Placebo v C19-IG 20% 1 g
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [75]
    P-value
    		 = 0.9853 [76]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.05
         upper limit
    		 3.12
    Notes
    [75] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [76] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required ICU admission between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    Placebo v C19-IG 20% 2 g
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [77]
    P-value
    		 = 0.989 [78]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.99
         upper limit
    		 3.07
    Notes
    [77] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [78] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects who required ICU admission between C19-IG 20% 2 g dose group and placebo.

    Secondary: Duration of ICU Stay Through Day 29

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    End point title
    		 Duration of ICU Stay Through Day 29
    End point description
    The duration (number of days) of ICU stay from post-randomisation through Day 29 was calculated based on ICU admission and discharge dates recorded. mITT population included the subset of ITT subjects who were also dosed. Here, “Subjects analysed” is the number of subjects who were admitted to the ICU.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    1
    1
    1
    Units: days
        median (full range (min-max))
    7.0 (7 to 7)
    5.0 (5 to 5)
    3.0 (3 to 3)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    2
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [79]
    P-value
    		 = 0.578
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.12
    Notes
    [79] - 95% CI for difference in LS mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable & treatment group as fixed effect, adjusting for baseline.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    2
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [80]
    P-value
    		 = 0.9065
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.1
    Notes
    [80] - 95% CI for difference in LS mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable & treatment group as fixed effect, adjusting for baseline.

    Secondary: Percentage of Subjects Requiring Invasive Mechanical Ventilation Through Day 29

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    End point title
    		 Percentage of Subjects Requiring Invasive Mechanical Ventilation Through Day 29
    End point description
    The percentage of subjects requiring invasive mechanical ventilation through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. mITT population included the subset of ITT subjects who were also dosed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (not applicable)
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Duration of Invasive Mechanical Ventilation Through Day 29

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    End point title
    		 Duration of Invasive Mechanical Ventilation Through Day 29
    End point description
    The duration (number of days) on invasive mechanical ventilation from post randomisation through Day 29 was calculated based on the start/stop dates of invasive mechanical ventilation. No subjects required mechanical ventilation throughout the study duration.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    0 [81]
    0 [82]
    0 [83]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [81] - "Subjects analysed" is 0 as no subjects required invasive mechanical ventilation.
    [82] - "Subjects analysed" is 0 as no subjects required invasive mechanical ventilation.
    [83] - "Subjects analysed" is 0 as no subjects required invasive mechanical ventilation.
    No statistical analyses for this end point

    Secondary: All-Cause Mortality Through Day 29

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    End point title
    		 All-Cause Mortality Through Day 29
    End point description
    All-cause mortality rate is the percentage of subjects in each treatment group who experienced mortality up to Day 29. mITT population included the subset of ITT subjects who were also dosed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Critical COVID-19 Illness

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    End point title
    		 Percentage of Subjects With Critical COVID-19 Illness
    End point description
    Critical COVID-19 illness was defined as any one of the following: (a) requiring ICU admission or ICU level of care, (b) invasive mechanical ventilation, or (c) resulting in death by Day 29. The percentage of subjects with critical COVID-19 illness defined above within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. mITT population included the subset of ITT subjects who were also dosed.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    152
    153
    156
    Units: percentage of subjects
        number (confidence interval 95%)
    0.66 (0.02 to 3.61)
    0.65 (0.02 to 3.59)
    0.64 (0.02 to 3.52)
    Statistical analysis title
    		 C19-IG 20% 1 g vs. Placebo
    Comparison groups
    C19-IG 20% 1 g v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [84]
    P-value
    		 = 0.9853 [85]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.05
         upper limit
    		 3.12
    Notes
    [84] - 95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.
    [85] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects with critical COVID-19 illness between C19-IG 20% 1 g dose group and placebo.
    Statistical analysis title
    		 C19-IG 20% 2 g vs. Placebo
    Comparison groups
    C19-IG 20% 2 g v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [86]
    P-value
    		 = 0.989 [87]
    Method
    		 Chi-squared
    Parameter type
    		 Difference in percentage
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.99
         upper limit
    		 3.07
    Notes
    [86] - 95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.
    [87] - p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of subjects with critical COVID-19 illness between C19-IG 20% 2 g dose group and placebo.

    Secondary: Length of Time to Clinical Progression to Critical COVID-19 Illness Through Day 29

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    End point title
    		 Length of Time to Clinical Progression to Critical COVID-19 Illness Through Day 29
    End point description
    Length of time to clinical progression to critical COVID-19 illness was defined as the time to death, invasive mechanical ventilation, or ICU admission/requiring ICU level of care. ICU level care is defined as the medical need for intensive or invasive monitoring; the immediate or impending need for the support of the airway, breathing, or circulation; and/or stabilisation of acute severe, or life-threatening complications of COVID-19. The time to clinical progression was estimated using the KM method. mITT population included the subset of ITT subjects who were also dosed. Here, "Subjects analysed" is the subjects who had clinical progression through Day 29. Subjects who did not meet the criteria for clinical progression were right censored as of the date of last subject’s contact on or prior to Day 29. "99999" indicates that the median and 95% CI were not estimable due to insufficient number of subjects with the events.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    1
    1
    1
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Time to COVID-19 Symptoms Through Day 14

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    End point title
    		 Time to COVID-19 Symptoms Through Day 14
    End point description
    Subjects were symptomatic if they a. experienced at least two of the following systemic symptoms: fever(≥38 ºC),chills,myalgia,headache,sore throat,cough,fatigue that interferes with activities of daily living,new olfactory/taste disorder(s),and vomiting/diarrhoea; b. experienced at least one of following respiratory signs/symptoms: new or worsening shortness of breath or difficulty breathing;c. experienced peripheral oxygen saturation by pulse oximetry(SpO2) <94% on room air;or d. had radiographical evidence of pneumonia. Time to COVID-19 symptoms was time from study drug administration to first time point when any of above elements was fulfilled through Day 14. Time to COVID-19 symptoms was estimated using KM method. mITT population included subset of ITT subjects who were also dosed. "Subjects analysed" is number of subjects who experienced symptoms through Day 14. "99999" indicates that median and 95% CI were not estimable due to insufficient number of subjects with the events.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    End point values
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Number of subjects analysed
    61
    54
    57
    Units: days
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of the study up to end of study (up to Day 60)
    Adverse event reporting additional description
    Safety population included all subjects who received any amount of C19-IG 20%/Placebo.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    C19-IG 20% 1 g
    Reporting group description
    		 Subjects received 1 g of C19-IG 20% SC infusion containing one syringe of 5 mL C19-IG 20% plus one syringe of 5 mL sterile 0.9% NaCl on Day 1.

    Reporting group title
    C19-IG 20% 2 g
    Reporting group description
    		 Subjects received 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% NaCl injection on Day 1.

    Serious adverse events
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 152 (1.97%)
    7 / 153 (4.58%)
    3 / 156 (1.92%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    3 / 152 (1.97%)
    7 / 153 (4.58%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 153 (0.00%)
    2 / 156 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 C19-IG 20% 1 g C19-IG 20% 2 g Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 152 (6.58%)
    8 / 153 (5.23%)
    5 / 156 (3.21%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 152 (6.58%)
    8 / 153 (5.23%)
    5 / 156 (3.21%)
         occurrences all number
    10
    8
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Mar 2021
    The purpose of the amendment was: 1. Radiographical studies were to be done for suspicion of pneumonia (they were previously optional). 2. The new exploratory objective added to include an overall assessment of COVID-19 symptoms severity on Day 7 and Day 29. 3. The Calculated Risk score was globally removed. It was considered better to perform subgroup analysis of known comorbidities affecting COVID-19 disease severity. 4. An independent data safety monitoring board (DSMB) review of interim safety data was added to occur when approximately 399 subjects had been randomised and treated with follow-up through Day 29 (approximately 133 subjects per randomised group). 5. New text was added delineating guidance for subsequent (post study) COVID-19 vaccine administrations and new subgroup analyses were added for comorbidities of special interest.
    27 Apr 2021
    The purpose of the amendment was to expand the recruitment age window to 30 years of age and older in order to facilitate enrollment and potentially benefit broader age range of SARS-CoV-2 positive individuals.
    28 Jun 2021
    The purpose of the amendment was to expand the recruitment age window to 18 years of age and older in order to facilitate enrollment and potentially benefit broader age range of SARS-CoV-2 positive individuals.
    13 Oct 2021
    The purpose of the amendment was: 1. To add a new secondary efficacy endpoint for time to COVID-19 symptoms based on a priori case definition. 2. Addition of an interim futility analysis which was to be conducted to provide guidance in the setting of dynamic changes within the context of an evolving epidemic.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Dec 2021
    The study was terminated for futility.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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