Trial Outcomes & Findings for Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression (NCT NCT04400058)

Last Updated: 2024-01-18

Results Overview

Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale. 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 ≥150mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

207 participants

Primary outcome timeframe

7 days

Results posted on

2024-01-18

Participant Flow

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

Participant milestones

Participant milestones
Measure	Octagam 10% Octagam 10% Octagam 10%: 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	Saline Solution Saline solution placebo group
Overall Study STARTED	105	102
Overall Study COMPLETED	84	86
Overall Study NOT COMPLETED	21	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Saline Solution n=102 Participants Saline solution placebo group	Total n=207 Participants Total of all reporting groups
Age, Continuous	57.6 years n=5 Participants	58.9 years n=7 Participants	58.2 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	48 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	54 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	76 Participants n=7 Participants	149 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	89 Participants n=7 Participants	176 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Body Mass Index (BMI)(kg/m^2)	31.47 kg/m^2 STANDARD_DEVIATION 5.570 • n=5 Participants	32.33 kg/m^2 STANDARD_DEVIATION 6.322 • n=7 Participants	31.88 kg/m^2 STANDARD_DEVIATION 5.934 • n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Placebo n=102 Participants Placebo Placebo: Placebo
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7	89 Participants	82 Participants

SECONDARY outcome

Timeframe: 33 days

Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33

Outcome measures

Outcome measures
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Placebo n=102 Participants Placebo Placebo: Placebo
Length of Hospital Stay (Time to Discharge)	12 days Interval 9.0 to 14.0	11 days Interval 9.0 to 15.0

SECONDARY outcome

Timeframe: 14 days

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.

Outcome measures

Outcome measures
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Placebo n=102 Participants Placebo Placebo: Placebo
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14	86 Participants	83 Participants

SECONDARY outcome

Timeframe: 33 days

Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33

Outcome measures

Outcome measures
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Placebo n=102 Participants Placebo Placebo: Placebo
Cumulative Duration of Invasive Mechanical Venitlation (IMV)	2.7 days Standard Deviation 8.05	1.6 days Standard Deviation 5.95

SECONDARY outcome

Timeframe: 33 days

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.

Outcome measures

Outcome measures
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Placebo n=102 Participants Placebo Placebo: Placebo
Number of Subjects With Severe Disease Progression	15 Participants	12 Participants

SECONDARY outcome

Timeframe: 33 days

Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33.

Outcome measures

Outcome measures
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Placebo n=102 Participants Placebo Placebo: Placebo
ICU Stay Length	4.6 days Standard Deviation 10.08	3.9 days Standard Deviation 8.83

SECONDARY outcome

Timeframe: 33 days

Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33

Outcome measures

Outcome measures
Measure	Octagam 10% n=105 Participants Octagam 10% Octagam 10%: 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	Placebo n=102 Participants Placebo Placebo: Placebo
Cumulative Mortality Rate Through Day 33	12 Participants	6 Participants

POST_HOC outcome

Timeframe: 3 months post-study

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

Outcome measures

Outcome measures
Measure	Octagam 10% n=84 Participants Octagam 10% Octagam 10%: 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	Placebo n=84 Participants Placebo Placebo: Placebo
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Worse	3 participants	5 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Worse	18 participants	29 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Poor	1 participants	1 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Fair	14 participants	24 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Good	30 participants	30 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Very Good	19 participants	15 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Excellent	6 participants	5 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Missing Answer	14 participants	9 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - The Same	29 participants	29 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Missing Answer	14 participants	9 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Missing answer	14 participants	9 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Experienced deterioration of your health without HCP documentation	4 participants	8 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Better	11 participants	7 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Better	9 participants	5 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Been Hospitalized	2 participants	7 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Sought consultation from HCP	21 participants	25 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - None of the above	43 participants	38 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 4 - Other	23 participants	27 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 4 - Similar to those during the COVID-19 hospitalization	9 participants	13 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 5 - Yes	53 participants	49 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 5 - No	17 participants	26 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 6 - Yes	45 participants	42 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire) Question 6 - No	25 participants	32 participants

POST_HOC outcome

Timeframe: 6 months post-study

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

Outcome measures

Outcome measures
Measure	Octagam 10% n=84 Participants Octagam 10% Octagam 10%: 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	Placebo n=84 Participants Placebo Placebo: Placebo
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Very Good	18 participants	19 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Sought consultation from HCP	12 participants	16 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Experienced deterioration of your health without HCP documentation	1 participants	0 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Missing answer	22 participants	16 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 4 - Similar to those during the COVID-19 hospitalization	6 participants	4 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Poor	0 participants	0 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Fair	15 participants	20 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Good	26 participants	22 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Missing Answer	21 participants	16 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Excellent	4 participants	7 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Worse	3 participants	4 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Worse	12 participants	12 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - The Same	30 participants	38 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Better	8 participants	9 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Better	10 participants	5 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Missing Answer	21 participants	16 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Been Hospitalized	0 participants	3 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - None of the above	49 participants	49 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 4 - Other	6 participants	18 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 5 - Yes	49 participants	43 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 5 - No	13 participants	25 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 6 - Yes	41 participants	39 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire) Question 6 - No	21 participants	29 participants

POST_HOC outcome

Timeframe: 9 months post-study

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

Outcome measures

Outcome measures
Measure	Octagam 10% n=84 Participants Octagam 10% Octagam 10%: 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	Placebo n=84 Participants Placebo Placebo: Placebo
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Poor	1 participants	1 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Experienced deterioration of your health without HCP documentation	5 participants	1 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - None of the above	41 participants	43 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Missing answer	21 participants	15 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 4 - Other	15 participants	23 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 4 - Similar to those during the COVID-19 hospitalization	9 participants	4 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 5 - Yes	49 participants	44 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 5 - No	14 participants	25 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 6 - Yes	46 participants	44 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 6 - No	17 participants	25 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Fair	10 participants	19 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Good	29 participants	31 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Very Good	19 participants	14 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Excellent	4 participants	4 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 1 - Missing Answer	21 participants	15 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Worse	3 participants	4 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Worse	13 participants	15 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - The Same	28 participants	38 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Better	10 participants	6 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Better	9 participants	6 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 2 - Missing Answer	21 participants	15 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Been Hospitalized	0 participants	2 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire) Question 3 - Sought consultation from HCP	17 participants	24 participants

POST_HOC outcome

Timeframe: 1-year post-study

Subjects who completed the core study and entered the registry were administered questionnaires at 1 year 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

Outcome measures

Outcome measures
Measure	Octagam 10% n=84 Participants Octagam 10% Octagam 10%: 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	Placebo n=84 Participants Placebo Placebo: Placebo
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 1 - Excellent	2 participants	3 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 2 - The Same	32 participants	44 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 3 - Been Hospitalized	1 participants	2 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 4 - Similar to those during the COVID-19 hospitalization	5 participants	5 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 5 - No	16 participants	23 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 1 - Poor	1 participants	1 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 1 - Fair	11 participants	14 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 1 - Good	35 participants	36 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 1 - Very Good	17 participants	13 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 1 - Missing Answer	18 participants	17 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Worse	2 participants	3 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Worse	15 participants	12 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 2 - Somewhat Better	12 participants	5 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 2 - Much Better	5 participants	3 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 2 - Missing Answer	18 participants	17 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 3 - Sought consultation from HCP	29 participants	22 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 3 - Experienced deterioration of your health without HCP documentation	2 participants	0 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 3 - None of the above	34 participants	43 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 3 - Missing answer	18 participants	17 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 4 - Other	27 participants	21 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 5 - Yes	50 participants	44 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 6 - Yes	44 participants	44 participants
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire) Question 6 - No	22 participants	23 participants

Adverse Events

Octagam 10%

Serious events: 15 serious events

Other events: 49 other events

Deaths: 13 deaths

Placebo

Serious events: 12 serious events

Other events: 40 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Octagam 10% n=105 participants at risk Octagam 10% Octagam 10%: 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	Placebo n=100 participants at risk Placebo Placebo: Placebo
Gastrointestinal disorders Constipation	9.5% 10/105 • Number of events 10 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	8.0% 8/100 • Number of events 8 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Gastrointestinal disorders Diarrhoea	5.7% 6/105 • Number of events 6 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	7.0% 7/100 • Number of events 7 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Metabolism and nutrition disorders Hyperglycemia	6.7% 7/105 • Number of events 7 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	4.0% 4/100 • Number of events 4 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Metabolism and nutrition disorders Hyponatraemia	6.7% 7/105 • Number of events 7 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	4.0% 4/100 • Number of events 4 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Metabolism and nutrition disorders Hypokalemia	2.9% 3/105 • Number of events 3 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	6.0% 6/100 • Number of events 6 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Psychiatric disorders Anxiety	7.6% 8/105 • Number of events 8 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	4.0% 4/100 • Number of events 4 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Psychiatric disorders Insomnia	6.7% 7/105 • Number of events 7 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	5.0% 5/100 • Number of events 5 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Nervous system disorders Headache	9.5% 10/105 • Number of events 10 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	7.0% 7/100 • Number of events 7 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Renal and urinary disorders Acute Kidney Injury	6.7% 7/105 • Number of events 7 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	5.0% 5/100 • Number of events 5 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	3.8% 4/105 • Number of events 4 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	6.0% 6/100 • Number of events 6 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.

Additional Information

Patrick Murphy

CRMG

Phone: 4138210022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Octagam 10% n=105 participants at risk Octagam 10% Octagam 10%: 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	Placebo n=100 participants at risk Placebo Placebo: Placebo
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.9% 2/105 • Number of events 2 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	5.0% 5/100 • Number of events 5 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.9% 3/105 • Number of events 3 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	2.9% 3/105 • Number of events 3 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.00% 0/105 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations Septic Shock	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	3.0% 3/100 • Number of events 3 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations COVID-19 Pneumonia	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations Pneumonia	0.00% 0/105 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations Bacterial Pneumonia	0.00% 0/105 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations Pneumococcal Pneumonia	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations Staphylococcal Pneumonia	0.00% 0/105 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations Viral Pneumonia	0.00% 0/105 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Infections and infestations Viral Cardiomyopathy	0.00% 0/105 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Renal and urinary disorders Acute Kidney Injury	3.8% 4/105 • Number of events 4 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Renal and urinary disorders Renal Failure	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Cardiac disorders Cardiac Arrest	1.9% 2/105 • Number of events 2 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Cardiac disorders Acute Myocardial Infarction	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Cardiac disorders Cardiopulmonary Failure	0.00% 0/105 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	1.0% 1/100 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
General disorders Multiple Organ Dysfunction Syndrome	2.9% 3/105 • Number of events 3 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Nervous system disorders Cerebral Haemorrhage	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.
Nervous system disorders Diabetic Hyperglycaemic Coma	0.95% 1/105 • Number of events 1 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.	0.00% 0/100 • 33 days Safety Population (SAF) analysed. SAF includes all subjects who are randomized and received any amount of IVIG or placebo. The analysis was conducted according to the treatment which subjects actually received.