Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Efficacy and safety of Octagam 10% therapy in COVID-19 patients with severe disease progression

    Summary
    EudraCT number
    		 2020-002482-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    31 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2024
    First version publication date
    31 Jan 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GAM10-10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04400058
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Octapharma Pharmazeutika Produktionsges.m.b.H
    Sponsor organisation address
    Oberlaaerstr. 235, Vienna, Austria, 1100
    Public contact
    Clinical Research & Development, Octapharma Pharmazeutika Produktionsges.m.b.H, +43 (1) 610 320, ClinicalRDVienna@groups.octapharma.com
    Scientific contact
    Clinical Research & Development, Octapharma Pharmazeutika Produktionsges.m.b.H, +43 (1) 610 320, ClinicalRDVienna@groups.octapharma.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
    31 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    GAM10-10 was a randomized, double-blind, placebo-controlled, multicenter, 2-arm adaptive Phase 3 study, designed to evaluate the efficacy and safety of high-dose Octagam 10% therapy in subjects with severe COVID-19. The primary endpoint was stabilization or improvement in modality needed to maintain oxygen supplementation as measured by modality required to maintain oxygen at entry.
    Protection of trial subjects
    The Protocol and amendments, a sample of the subject information and informed consent form and any other materials provided to the subjects for the study, and further requested information, were reviewed and approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to the initiation of the study. The study was approved by the IEC/IRB and the Regulatory Authority before any investigational medicinal product (IMP) was shipped to the study sites and any subject was exposed to a study-related procedure.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jun 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 126
    Country: Number of subjects enrolled
    Ukraine: 43
    Country: Number of subjects enrolled
    Russian Federation: 38
    Worldwide total number of subjects
    207
    EEA total number of subjects
    0
    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)
    150
    From 65 to 84 years
    56
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 207 patients were enrolled between June 2020 and February 2021 at 23 sites across the United States, Ukraine and Russia

    Pre-assignment
    Screening details
    		 A total of 219 patients were screened, with 207 enrolled and randomized into Octagam 10% and placebo arm in 1:1 ratio

    Period 1
    Period 1 title
    Core Study (33 Days)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Octagam 10%
    Arm description
    		 Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Octagam 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days

    Arm title
    		 Saline Solution
    Arm description
    		 IV saline solution placebo group
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infusion
    Dosage and administration details
    Saline Solution administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days

    Number of subjects in period 1
    		Octagam 10% Saline Solution
    Started
    105
    102
    Completed
    84
    86
    Not completed
    21
    16
         Consent withdrawn by subject
    2
    1
         Physician decision
    1
    -
         Death unrelated to IP
    12
    6
         Adverse event, non-fatal
    -
    2
         Other
    -
    1
         Lost to follow-up
    6
    6
    Period 2
    Period 2 title
    1 Year Follow-Up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Octagam 10%
    Arm description
    		 Treated with Octagam 10%, in Period 1, no IMP treatment in Period 2
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Saline Solution
    Arm description
    		 Treated with IV saline solution placebo group in Period 1, no IMP treatment in Period 2
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Octagam 10% Saline Solution
    Started
    84
    84
    Completed
    66
    67
    Not completed
    18
    17
         Consent withdrawn by subject
    2
    1
         Subject deceased
    4
    2
         Lost to follow-up
    12
    14

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Core Study (33 Days)
    Reporting group description
    		 -

    Reporting group values
    		 Core Study (33 Days) Total
    Number of subjects
    		 207 207
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 150 150
        From 65-84 years
    		 56 56
        85 years and over
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 59 (26 to 89) -
    Gender categorical
    Units: Subjects
        Female
    		 88 88
        Male
    		 119 119
    BMI
    Subjects mean Body Mass Index (BMI)
    Units: Body Mass Index
        median (standard deviation)
    		 31.88 ( 5.934 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Octagam 10%
    Reporting group description
    		 Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days

    Reporting group title
    Saline Solution
    Reporting group description
    		 IV saline solution placebo group
    Reporting group title
    Octagam 10%
    Reporting group description
    		 Treated with Octagam 10%, in Period 1, no IMP treatment in Period 2

    Reporting group title
    Saline Solution
    Reporting group description
    		 Treated with IV saline solution placebo group in Period 1, no IMP treatment in Period 2

    Primary: Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7

    		 Close Top of page
    End point title
    		 Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
    End point description
    Proportion of subjects reaching stabilization or improvement in clinical status at Day 7 on at least one category on a 6-point clinical status scale. Clinical status categories were be defined as: 1. Hospital discharge or meet discharge criteria (discharge criteria were defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). 2. Hospitalization, not requiring supplemental oxygen. 3. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
    End point type
    Primary
    End point timeframe
    7 days
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    105
    102
    Units: Participants
    number (not applicable)
        Participants
    89
    82
        (%)
    84.8
    80.4
    Statistical analysis title
    		 Subjects with stable or improved clinical status
    Statistical analysis description
    Proportion of subjects with stable or improved clinical status at Day 7 in Octagam group compared to the placebo group. Clinical status category was based on a 6-point scale. Baseline clinical status was defined as the most recent value prior to treatment.
    Comparison groups
    Octagam 10% v Saline Solution
    Number of subjects included in analysis
    207
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.386
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - The null hypothesis of no difference in proportion of subjects who reach success in two treatment groups was tested vs. the alternative hypothesis that there that there is a difference between proportions of subjects who reach success in two groups. Hypothesis testing will be performed using Cochran-Mantel-Haenszel (CMH) stratified by age category (≤65 versus >65) at a two-sided 0.05 significance level.

    Secondary: Length of Hospital Stay (Time to Discharge)

    		 Close Top of page
    End point title
    		 Length of Hospital Stay (Time to Discharge)
    End point description
    Median length of hospital stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33. Clinical status categories were defined as: Hospital discharge or meet discharge criteria (discharge criteria were defined as clinical recovery, i.e., no fever, respiratory rate, oxygensaturation return to normal, and cough relief.
    End point type
    Secondary
    End point timeframe
    33 days
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    105
    102
    Units: Days
    median (confidence interval 95%)
        Days
    12 (9 to 14)
    11 (9 to 15)
    No statistical analyses for this end point

    Secondary: Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14

    		 Close Top of page
    End point title
    		 Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14
    End point description
    Number of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14. Clinical status categories will be defined as: 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). 2. Hospitalization, not requiring supplemental oxygen. 3. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy,as defined by A-a Gradient ≥ 150 mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
    End point type
    Secondary
    End point timeframe
    14 days
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    105
    102
    Units: Participants
        Participants
    86
    83
    No statistical analyses for this end point

    Secondary: Cumulative Duration of Invasive Mechanical Venitlation (IMV)

    		 Close Top of page
    End point title
    		 Cumulative Duration of Invasive Mechanical Venitlation (IMV)
    End point description
    Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33
    End point type
    Secondary
    End point timeframe
    33 days
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    105
    102
    Units: Days
    arithmetic mean (standard deviation)
        Days
    2.7 ( 8.05 )
    1.6 ( 5.95 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Severe Disease Progression

    		 Close Top of page
    End point title
    		 Number of Subjects With Severe Disease Progression
    End point description
    Number of subjects who experienced severe disease progression while treated with Octagam 10% compared to those that received placebo at Day 33. Severe disease progression is defined as subjects requiring extracorporeal membrane oxygenation, mechanical ventilation and/or died through day 33.
    End point type
    Secondary
    End point timeframe
    33 days
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    105
    102
    Units: Participants
        Participants
    15
    12
    No statistical analyses for this end point

    Secondary: ICU Stay Length

    		 Close Top of page
    End point title
    		 ICU Stay Length
    End point description
    Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33.
    End point type
    Secondary
    End point timeframe
    33 days
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    105
    102
    Units: Days
    arithmetic mean (standard deviation)
        Days
    4.6 ( 10.08 )
    3.9 ( 8.83 )
    No statistical analyses for this end point

    Secondary: Cumulative Mortality Rate Through Day 33

    		 Close Top of page
    End point title
    		 Cumulative Mortality Rate Through Day 33
    End point description
    Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33
    End point type
    Secondary
    End point timeframe
    33 days
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    105
    102
    Units: Participants
        Participants
    12
    6
    No statistical analyses for this end point

    Post-hoc: Post Study Health Status, Any Residual Health Effects from COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire)

    		 Close Top of page
    End point title
    		 Post Study Health Status, Any Residual Health Effects from COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire)
    End point description
    Subjects who completed the core study and entered the registry were administered questionnaires at 3 months asking about their general health. Subjects were asked: How is your general health? 1. Poor 2. Fair 3. Good 4. Very Good 5. Excellent 6. Missing How would you compare your general health now to what it was before you were ill with Covid-19? 1. Much worse 2. Somewhat worse 3. The same 4. Somewhat better 5. Much better 6. Missing Since last contact, have you? 1. Been hospitalized 2. Sought consultation from a health care professional 3. Experienced deterioration of your health without seeking HCP consultation 4. None of the above 5. Missing If the above question was not "none of the above", was it in relation to the symptoms? 1. Other 2. Similar to the symptoms experienced during COVID-19 hospitalization Prior to Covid-19 did you work or go to school full time? 1. Yes 2. No Do you currently work or go to school full time? 1. Yes 2. No
    End point type
    Post-hoc
    End point timeframe
    3 months post-study
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    84
    84
    Units: Number on a scale
        Question 1 - Poor
    1
    1
        Question 1 - Fair
    14
    24
        Question 1 - Good
    30
    30
        Question 1 - Very Good
    19
    15
        Question 1 - Excellent
    6
    5
        Question 1 - Missing Answer
    14
    9
        Question 2 - Much worse
    3
    5
        Question 2 - Somewhat Worse
    18
    29
        Question 2 - The Same
    29
    29
        Question 2 - Somewhat Better
    11
    7
        Question 2 - Much Better
    9
    5
        Question 2 - Missing Answer
    14
    9
        Question 3 - Been Hospitalized
    2
    7
        Question 3 - Sought Consultation from HCP
    21
    25
        Question 3 - Experienced deterioration of your hea
    4
    8
        Question 3 - None of the above
    43
    38
        Question 3 - Missing answer
    14
    9
        Question 4 - Other
    23
    27
        Question 4 - Similar to those during the COVID-19
    9
    13
        Question 5 - Yes
    53
    49
        Question 5 - No
    17
    26
        Question 6 - Yes
    45
    42
        Question 6 - No
    25
    32
    No statistical analyses for this end point

    Post-hoc: Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment-6 Months Post-Study (COVID-19 Subject Questionnaire)

    		 Close Top of page
    End point title
    		 Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment-6 Months Post-Study (COVID-19 Subject Questionnaire)
    End point description
    Subjects who completed the core study and entered the registry were administered questionnaires at 6 months asking about their general health. Subjects were asked: How is your general health? 1.Poor 2.Fair 3.Good 4.Very Good 5.Excellent 6.Missing How would you compare your general health now to what it was before you were ill with Covid-19? 1.Much worse 2.Somewhat worse 3.The same 4.Somewhat better 5.Much better 6.Missing Since last contact, have you? 1.Been hospitalized 2.Sought consultation from a health care professional 3.Experienced deterioration of your health without seeking HCP consultation 4.None of the above 5.Missing If the above question was not "none of the above", was it in relation to the symptoms? 1.Other 2.Similar to the symptoms experienced during COVID-19 hospitalization Prior to Covid-19 did you work or go to school full time? 1.Yes 2.No Do you currently work or go to school full time? 1.Yes 2.No
    End point type
    Post-hoc
    End point timeframe
    6 months post-study
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    84
    84
    Units: participants
    number (not applicable)
        Question 1 - Poor
    0
    0
        Question 1 - Fair
    15
    20
        Question 1 - Good
    26
    22
        Question 1 - Very Good
    18
    19
        Question 1 - Excellent
    4
    7
        Question 1 - Missing Answer
    21
    16
        Question 2 - Much Worse
    3
    4
        Question 2 - Somewhat Worse
    12
    12
        Question 2 - The Same
    30
    38
        Question 2 - Somewhat Better
    8
    9
        Question 2 - Much Better
    10
    5
        Question 2 - Missing Answer
    21
    16
        Question 3 - Been Hospitalized
    0
    3
        Question 3 - Sought consultation from HCP
    12
    16
        Question 3 - Experienced deterioration of health
    1
    0
        Question 3 - None of the above
    49
    49
        Question 3 - Missing answer
    22
    16
        Question 4 - Other
    6
    18
        Question 4 -Similar to those during COVID-19 hosp.
    6
    4
        Question 5 - Yes
    49
    43
        Question 5 - No
    13
    25
        Question 6 - Yes
    41
    39
        Question 6 - No
    21
    29
    No statistical analyses for this end point

    Post-hoc: Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment-9 Months Post-Study (COVID-19 Subject Questionnaire)

    		 Close Top of page
    End point title
    		 Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment-9 Months Post-Study (COVID-19 Subject Questionnaire)
    End point description
    Subjects who completed the core study and entered the registry were administered questionnaires at 9 months asking about their general health. Subjects were asked: How is your general health? 1. Poor 2. Fair 3. Good 4. Very Good 5. Excellent 6. Missing How would you compare your general health now to what it was before you were ill with Covid-19? 1. Much worse 2. Somewhat worse 3. The same 4. Somewhat better 5. Much better 6. Missing Since last contact, have you? 1. Been hospitalized 2. Sought consultation from a health care professional 3. Experienced deterioration of your health without seeking HCP consultation 4. None of the above 5. Missing If the above question was not "none of the above", was it in relation to the symptoms? 1. Other 2. Similar to the symptoms experienced during COVID-19 hospitalization Prior to Covid-19 did you work or go to school full time? 1. Yes 2. No Do you currently work or go to school full time? 1. Yes 2. No
    End point type
    Post-hoc
    End point timeframe
    9 months post-study
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    84
    84
    Units: participants
    number (not applicable)
        Question 1 - Poor
    1
    1
        Question 1 - Fair
    10
    19
        Question 1 - Good
    29
    31
        Question 1 - Very Good
    19
    14
        Question 1 - Excellent
    4
    4
        Question 1 - Missing Answer
    21
    15
        Question 2 - Much Worse
    3
    4
        Question 2 - Somewhat Worse
    13
    15
        Question 2 - The Same
    28
    38
        Question 2 - Somewhat Better
    10
    6
        Question 2 - Much Better
    9
    6
        Question 2 - Missing Answer
    21
    15
        Question 3 - Been Hospitalized
    0
    2
        Question 3 - Sought consultation from HCP
    17
    24
        Question 3 - Experienced deterioration of health
    5
    1
        Question 3 - None of the above
    41
    43
        Question 3 - Missing answer
    21
    15
        Question 4 - Other
    15
    23
        Question 4 -Similar to those during COVID-19 hosp.
    9
    4
        Question 5 - Yes
    49
    44
        Question 5 - No
    14
    25
        Question 6 - Yes
    46
    44
        Question 6 - No
    17
    25
    No statistical analyses for this end point

    Post-hoc: Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment-12 Months Post-Study (COVID-19 Subject Questionnaire)

    		 Close Top of page
    End point title
    		 Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment-12 Months Post-Study (COVID-19 Subject Questionnaire)
    End point description
    Subjects who completed the core study and entered the registry were administered questionnaires at 12 months asking about their general health. Subjects were asked: How is your general health? 1. Poor 2. Fair 3. Good 4. Very Good 5. Excellent 6. Missing How would you compare your general health now to what it was before you were ill with Covid-19? 1. Much worse 2. Somewhat worse 3. The same 4. Somewhat better 5. Much better 6. Missing Since last contact, have you? 1. Been hospitalized 2. Sought consultation from a health care professional 3. Experienced deterioration of your health without seeking HCP consultation 4. None of the above 5. Missing If the above question was not "none of the above", was it in relation to the symptoms? 1. Other 2. Similar to the symptoms experienced during COVID-19 hospitalization Prior to Covid-19 did you work or go to school full time? 1. Yes 2. No Do you currently work or go to school full time? 1. Yes 2. No
    End point type
    Post-hoc
    End point timeframe
    12 months post-study
    End point values
    		 Octagam 10% Saline Solution
    Number of subjects analysed
    84
    84
    Units: participants
    number (not applicable)
        Question 1 - Poor
    1
    1
        Question 1 - Fair
    11
    14
        Question 1 - Good
    35
    36
        Question 1 - Very Good
    17
    13
        Question 1 - Excellent
    2
    3
        Question 1 - Missing Answer
    18
    17
        Question 2 - Much Worse
    2
    3
        Question 2 - Somewhat Worse
    15
    12
        Question 2 - The Same
    32
    44
        Question 2 - Somewhat Better
    12
    5
        Question 2 - Much Better
    5
    3
        Question 2 - Missing Answer
    18
    17
        Question 3 - Been Hospitalized
    1
    2
        Question 3 - Sought consultation from HCP
    29
    22
        Question 3 - Experienced deterioration of health
    2
    0
        Question 3 - None of the above
    34
    43
        Question 3 - Missing answer
    18
    17
        Question 4 - Other
    27
    21
        Question 4 -Similar to those during COVID-19 hosp.
    5
    5
        Question 5 - Yes
    50
    44
        Question 5 - No
    16
    23
        Question 6 - Yes
    44
    44
        Question 6 - No
    22
    23
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Approximately 33 Days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Octagam 10%
    Reporting group description
    		 Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days

    Reporting group title
    Saline Solution
    Reporting group description
    		 Saline solution placebo group

    Serious adverse events
    		 Octagam 10% Saline Solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 105 (14.29%)
    12 / 100 (12.00%)
         number of deaths (all causes)
    13
    6
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 105 (1.90%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic hyperglycaemic coma
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    3 / 105 (2.86%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 105 (1.90%)
    5 / 100 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Lung disorder
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 105 (2.86%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    4 / 105 (3.81%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 Pneumonia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococal Pneumonia
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 100 (1.00%)
         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
    1 / 105 (0.95%)
    3 / 100 (3.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral cardiomyopathy
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Pneumonia
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 100 (1.00%)
         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: 5%
    Non-serious adverse events
    		 Octagam 10% Saline Solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 105 (46.67%)
    40 / 100 (40.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 105 (9.52%)
    7 / 100 (7.00%)
         occurrences all number
    10
    7
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    10 / 105 (9.52%)
    8 / 100 (8.00%)
         occurrences all number
    10
    8
    Diarrhoea
         subjects affected / exposed
    6 / 105 (5.71%)
    7 / 100 (7.00%)
         occurrences all number
    6
    7
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    4 / 105 (3.81%)
    6 / 100 (6.00%)
         occurrences all number
    4
    6
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    8 / 105 (7.62%)
    4 / 100 (4.00%)
         occurrences all number
    8
    4
    Insomnia
         subjects affected / exposed
    7 / 105 (6.67%)
    5 / 100 (5.00%)
         occurrences all number
    7
    5
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    7 / 105 (6.67%)
    5 / 100 (5.00%)
         occurrences all number
    7
    5
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    7 / 105 (6.67%)
    4 / 100 (4.00%)
         occurrences all number
    7
    4
    Hypokalaemia
         subjects affected / exposed
    3 / 105 (2.86%)
    6 / 100 (6.00%)
         occurrences all number
    3
    6
    Hyponatraemia
         subjects affected / exposed
    7 / 105 (6.67%)
    4 / 100 (4.00%)
         occurrences all number
    7
    4

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 May 2020
    Protocol V3.0 dated 20May2020
    08 Jun 2020
    Protocol v4.0 dated 08Jun2020
    01 Jul 2020
    Protocol V5.0 dated 01Jul2020
    04 Aug 2020
    Protocol V6.0 dated 04Aug2020
    18 Sep 2020
    Protocol V7.0 dated 18Sep2020

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 01 19:04:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA