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    Clinical Trial Results:
    An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19

    Summary
    EudraCT number
    		 2020-002542-16
    Trial protocol
    		 GB   GR   DK   DE  
    Global end of trial date
    21 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions
    Summary report(s)
    		 ITAC Primary manuscript
    ITAC supplemental materials to publication

    Trial information

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    Trial identification
    Sponsor protocol code
    INSIGHT013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04546581
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regents of the University of Minnesota
    Sponsor organisation address
    Office of the Vice President for Research, 420 Johnston Hall, 101 Pleasant St SE, Minneapolis, United States, 55455
    Public contact
    Sarah Pett, MRC CTU at UCL, 44 02076704700, s.pett@ucl.ac.uk
    Scientific contact
    Sarah Pett, MRC CTU at UCL, 44 02076704700, s.pett@ucl.ac.uk
    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 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications: 7. Death 6. End-organ failure 5. Life-threatening end-organ dysfunction 4. Serious end-organ dysfunction 3. Moderate end-organ dysfunction 2. Limiting symptoms due to COVID-19 1. No limiting symptoms due to COVID-19 The rationale behind this approach is to estimate in a clinically meaningful way whether the study drug has had a favourable clinical impact on the patient.
    Protection of trial subjects
    Informed consent. Clinical assessment immediately prior to study infusion to ensure participant is still eligible to receive the study product. Careful clinical monitoring during infusion of study agent and for at least 2 hours afterward.
    Background therapy
    		 Remdesivir was be administered as a 200 mg IV loading dose (100 mL volume) on the first day of its infusion followed by 100mg daily for the course described below; remdesivir may have commenced prior to randomization. For participants starting remdesivir after randomization to hIVIG/placebo, the loading dose was to be given immediately after the infusion of hIVIG/placebo, once any infusion reactions from that infusion have resolved; for those who commenced remdesivir prior to randomization, the usual maintenance dose of 100 mg was to be given after the hIVIG/placebo infusion on Day 0 in the same manner. After the first remdesivir infusion, a 100 mg once-daily IV maintenance dose (also 100 mL volume) was given each day while hospitalized for up to a 10 day total course; shorter durations of 5 days could be considered by the clinical investigator as appropriate in patients who are not ventilated. Infusions were not given to participants after discharge. The total treatment course was not to exceed 10 calendar days even if an infusion was missed.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    Spain: 65
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    Denmark: 77
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Greece: 70
    Country: Number of subjects enrolled
    Indonesia: 33
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    Japan: 15
    Country: Number of subjects enrolled
    Nigeria: 41
    Country: Number of subjects enrolled
    United States: 253
    Worldwide total number of subjects
    593
    EEA total number of subjects
    222
    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)
    371
    From 65 to 84 years
    204
    85 years and over
    18

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from participating hospitals between 8 Oct 2020 and 10 Feb 2021.

    Pre-assignment
    Screening details
    		 Hospitalized adults with COVID-19

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Randomizer was given a treatment ID, which was sent to the pharmacy. The ID was decoded in the pharmacy. A saline placebo infusion was used. The infusion bag was covered with a colored sleeve to mask the slight difference in color between the active product and placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 hIVIG
    Arm description
    		 SARS-CoV-2 hyperimmune intravenous immunoglobulin (hIVIG) was administered intravenously as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of 40 g (or 400 mL). SARS-CoV-2 Immunoglobulin Intravenous (human) is a human hyperimmune product of the purified gamma globulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2. hIVIG is prepared from pooled plasma collected from healthy, adult donors who have recovered from SARS-CoV-2 infection. Four hIVIG products were used in this trial: CSL Behring SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), Emergent SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), Grifols SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), and Takeda SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG).
    Arm type
    		 Experimental

    Investigational medicinal product name
    hIVIG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The hIVIG product was administered as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of (40 g or 400 mL).

    Arm title
    		 Placebo
    Arm description
    		 Normal saline was administered as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of 40 g (or 400 mL)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Normal saline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Normal saline was administered as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of 40 g (or 400 mL)

    Number of subjects in period 1
    		hIVIG Placebo
    Started
    301
    292
    Completed
    288
    279
    Not completed
    13
    13
         Consent withdrawn by subject
    3
    7
         Adverse event, non-fatal
    9
    3
         Administrative withdrawal
    -
    1
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    hIVIG
    Reporting group description
    		 SARS-CoV-2 hyperimmune intravenous immunoglobulin (hIVIG) was administered intravenously as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of 40 g (or 400 mL). SARS-CoV-2 Immunoglobulin Intravenous (human) is a human hyperimmune product of the purified gamma globulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2. hIVIG is prepared from pooled plasma collected from healthy, adult donors who have recovered from SARS-CoV-2 infection. Four hIVIG products were used in this trial: CSL Behring SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), Emergent SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), Grifols SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), and Takeda SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG).

    Reporting group title
    Placebo
    Reporting group description
    		 Normal saline was administered as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of 40 g (or 400 mL)

    Reporting group values
    		 hIVIG Placebo Total
    Number of subjects
    		 301 292 593
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.4 ( 15.1 ) 59.7 ( 13.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 149 108 257
        Male
    		 152 184 336
    Subject analysis sets

    Subject analysis set title
    hIVIG - mITT population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analyses were performed on a modified intention to treat (mITT) population, which included all randomized participants who met eligibility criteria and received all or part of the assigned study product infusion. Of the 301 participants randomized to hIVIG, 295 were included in the mITT population.

    Subject analysis set title
    Placebo - mITT population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analyses were performed on a modified intention to treat (mITT) population, which included all randomized participants who met eligibility criteria and received all or part of the assigned study product infusion. Of the 292 participants randomized to placebo, 284 were included in the mITT population.

    Subject analysis sets values
    		 hIVIG - mITT population Placebo - mITT population
    Number of subjects
    295
    284
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    58.4 ( 15.2 )
    59.5 ( 13.8 )
    Gender categorical
    Units: Subjects
        Female
    146
    104
        Male
    149
    180

    End points

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    End points reporting groups
    Reporting group title
    hIVIG
    Reporting group description
    		 SARS-CoV-2 hyperimmune intravenous immunoglobulin (hIVIG) was administered intravenously as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of 40 g (or 400 mL). SARS-CoV-2 Immunoglobulin Intravenous (human) is a human hyperimmune product of the purified gamma globulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2. hIVIG is prepared from pooled plasma collected from healthy, adult donors who have recovered from SARS-CoV-2 infection. Four hIVIG products were used in this trial: CSL Behring SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), Emergent SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), Grifols SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG), and Takeda SARS-CoV-2 Hyperimmune Immunoglobulin Intravenous (human) (hIVIG).

    Reporting group title
    Placebo
    Reporting group description
    		 Normal saline was administered as a single dose of 400 mg/kg (or 0.4 g/kg) body weight, to a maximum dose of 40 g (or 400 mL)

    Subject analysis set title
    hIVIG - mITT population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analyses were performed on a modified intention to treat (mITT) population, which included all randomized participants who met eligibility criteria and received all or part of the assigned study product infusion. Of the 301 participants randomized to hIVIG, 295 were included in the mITT population.

    Subject analysis set title
    Placebo - mITT population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Analyses were performed on a modified intention to treat (mITT) population, which included all randomized participants who met eligibility criteria and received all or part of the assigned study product infusion. Of the 292 participants randomized to placebo, 284 were included in the mITT population.

    Primary: Day 7 Ordinal Outcome

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    End point title
    		 Day 7 Ordinal Outcome
    End point description
    Ordinal outcome with 7 mutually exclusive categories. On Day 7, the worst of the 7 categories the participant was in that day will constitute the primary outcome for that patient. The 7 categories are: 7) Death, 6) End-organ failure, 5) Life-threatening end-organ dysfunction, 4) Serious end-organ dysfunction, 3) Moderate end-organ dysfunction, 2) Limiting symptoms due to COVID-19, 1) No limiting symptoms due to COVID-19
    End point type
    Primary
    End point timeframe
    Status on Day 7
    End point values
    		 hIVIG - mITT population Placebo - mITT population
    Number of subjects analysed
    295 [1]
    284 [2]
    Units: Percent
        Death
    5
    5
        End-organ failure
    9
    13
        Life-threatening end-organ dysfunction
    26
    26
        Serious end-organ dysfunction
    25
    30
        Moderate end-organ dysfunction
    32
    28
        Limiting symptoms due to COVID-19
    67
    61
        No limiting symptoms due to COVID-19
    129
    116
    Notes
    [1] - 295 were analyzed for this endpoint; Multiple imputation was performed for the 2 with missing data
    [2] - 284 were analyzed for this endpoint; Multiple imputation was performed for the 5 with missing data
    Statistical analysis title
    		 Main analysis
    Comparison groups
    hIVIG - mITT population v Placebo - mITT population
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.72
    Method
    		 Regression, Logistic
    Parameter type
    		 Proportional odds ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.45

    Secondary: All-cause mortality through Day 28

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    End point title
    		 All-cause mortality through Day 28
    End point description
    The mortality rate was estimated as the percentage of participants who died by study day 28
    End point type
    Secondary
    End point timeframe
    Entire trial (through Day 28)
    End point values
    		 hIVIG - mITT population Placebo - mITT population
    Number of subjects analysed
    295
    284
    Units: percent
        number (confidence interval 95%)
    6 (4 to 10)
    8 (5 to 12)
    Statistical analysis title
    		 All-cause mortality through Day 28
    Comparison groups
    hIVIG - mITT population v Placebo - mITT population
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.51

    Secondary: Primary Safety Outcome

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    End point title
    		 Primary Safety Outcome
    End point description
    Primary safety outcome - Death, SAE or Grade 3 or 4 event through Day 7
    End point type
    Secondary
    End point timeframe
    Through Day 7
    End point values
    		 hIVIG - mITT population Placebo - mITT population
    Number of subjects analysed
    295
    284
    Units: Participants
    71
    70
    Statistical analysis title
    		 Odds ratio (OR) for primary safety outcome
    Statistical analysis description
    hIVIG/placebo odds ratio for primary safety outcome
    Comparison groups
    hIVIG - mITT population v Placebo - mITT population
    Number of subjects included in analysis
    579
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.91
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.46

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Grade 3 and 4 AEs were reported through Day 7, SAEs were report through all of follow-up (through Day 28)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    hIVIG - Infused
    Reporting group description
    		 hIVIG participants who received any amount of infusion

    Reporting group title
    Placebo - infused
    Reporting group description
    		 Placebo participants receiving any amount of infusion

    Serious adverse events
    		 hIVIG - Infused Placebo - infused
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 297 (5.39%)
    20 / 284 (7.04%)
         number of deaths (all causes)
    18
    22
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         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
    Anaemia
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 284 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (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
    Pyrexia
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 284 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 297 (1.01%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 284 (0.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    COVID-19
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         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 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 hIVIG - Infused Placebo - infused
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 297 (15.49%)
    35 / 284 (12.32%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 297 (1.01%)
    1 / 284 (0.35%)
         occurrences all number
    3
    1
    Hypertension
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences all number
    1
    1
    Haemorrhage
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 297 (3.37%)
    5 / 284 (1.76%)
         occurrences all number
    10
    6
    Chills
         subjects affected / exposed
    10 / 297 (3.37%)
    0 / 284 (0.00%)
         occurrences all number
    10
    0
    Fatigue
         subjects affected / exposed
    1 / 297 (0.34%)
    3 / 284 (1.06%)
         occurrences all number
    1
    3
    Asthenia
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Chest pain
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Social circumstances
    Dependence on oxygen therapy
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    10 / 297 (3.37%)
    5 / 284 (1.76%)
         occurrences all number
    13
    6
    Respiratory distress
         subjects affected / exposed
    6 / 297 (2.02%)
    5 / 284 (1.76%)
         occurrences all number
    7
    6
    Respiratory failure
         subjects affected / exposed
    4 / 297 (1.35%)
    3 / 284 (1.06%)
         occurrences all number
    4
    3
    Cough
         subjects affected / exposed
    2 / 297 (0.67%)
    2 / 284 (0.70%)
         occurrences all number
    2
    2
    Hypoxia
         subjects affected / exposed
    3 / 297 (1.01%)
    0 / 284 (0.00%)
         occurrences all number
    3
    0
    Acute respiratory failure
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Bronchiectasis
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Haemoptysis
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Interstitial lung disease
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Pulmonary oedema
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences all number
    1
    1
    Mental status changes
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences all number
    1
    1
    Tachycardia
         subjects affected / exposed
    0 / 297 (0.00%)
    2 / 284 (0.70%)
         occurrences all number
    0
    2
    Bradycardia
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Left ventricular failure
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Myocardial infarction
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Myocarditis
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 284 (0.70%)
         occurrences all number
    1
    2
    Anosmia
         subjects affected / exposed
    1 / 297 (0.34%)
    2 / 284 (0.70%)
         occurrences all number
    1
    2
    Headache
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Lethargy
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 297 (1.01%)
    0 / 284 (0.00%)
         occurrences all number
    3
    0
    Leukopenia
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences all number
    1
    1
    Anuria
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Oliguria
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Muscle rigidity
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 297 (0.00%)
    1 / 284 (0.35%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences all number
    1
    1
    Pneumonia
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Septic shock
         subjects affected / exposed
    1 / 297 (0.34%)
    0 / 284 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 297 (0.34%)
    1 / 284 (0.35%)
         occurrences all number
    1
    1

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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