Covid-19
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
Interventions
BIOLOGICALOctagam 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
OTHERSaline Solution
Placebo
Sponsors
Octapharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult aged ≥18years old 2. Provide voluntary, fully informed written and signed consent before any study-related procedures are conducted 3. Able to understand and comply with the relevant aspects of the study protocol 4. Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or lower respiratory tract samples 5. Hospitalized with a resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio \<300mmHg. Measurement can be taken from documented source records in the 24 hours prior to screening 6. Chest imaging confirming lung involvement
Exclusion criteria
1. Existence of other evidence that can explain pneumonia including but not limited to: Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the combined clinical picture, radiological findings and known laboratory results \[eg, elevated procalcitonin \>0.5ng/mL and concomitant neutrophilia\]), known fungal pneumonia, suspected fungal pneumonia based on compromised immune system with a history of past fungal infections, noninfectious causes, etc. 2. Known history of serious allergic reactions, including anaphylaxis, to IVIG or its preparation components 3. Subjects with a history of thromboembolic event (TEE) within the last 12 months, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV) 4. Subjects with an underlying medical condition that can lead to hypercoagulable states and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C deficiency, antiphospholipid syndrome and malignancy 5. Known history of selective IgA deficiency with antibodies against IgA 6. Subjects with conditions such as human immunodeficiency virus (HIV) infection, known acute or chronic hepatitis B or C (HBsAg positive or HCV ribonucleic acid (RNA) PCR positive or currently treated with antivirals), pulmonary fibrosis, elevated procalcitonin (\> 0.5) with concomitant neutrophilia (elevated polys), heparin induced thrombocytopenia (HIT), and moderate to severe renal dysfunction (per investigator discretion based on estimated glomerular filtration rate \[eGFR\] \<59 mL/min/1.73 m2, as defined by KDIGO Clinical Practice Guideline): * Moderately reduced GFR (G3a): GFR = 45 to 59 ml/min/1.73 m2 * Moderately reduced GFR (G3b): GFR = 30 to 44 ml/min/1.73 m2 * Severely reduced GFR (G4): GFR = 15 to 29 ml/min/1.73 m2 * Kidney failure (G5): GFR \<15 ml/min/1.73 m2 7. Currently requiring IMV (invasive mechanical ventilation or having received IMV during the last 30 days 8. Known clinically significant preexisting lung, heart, or neuromuscular disease that, in the investigator's opinion, would impact subject's ability to complete study or may confound the study results 9. Body weight \>125 kg 10. Women who are pregnant or breast-feeding 11. Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin agents (eg, Tocilizumab), or interferons for their COVID-19 disease before enrollment or plan to receive this treatment during the course of the study 12. Enrolled in other experimental interventional studies or taking experimental medications (ie, convalescent plasma). Diagnostic studies can be allowed if the anticipated total blood volume to be drawn across both studies and for therapeutic purposes does not exceed 450 mL over any 8-week period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7 | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14 | 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. |
| Cumulative Duration of Invasive Mechanical Venitlation (IMV) | 33 days | Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33 |
| Length of Hospital Stay (Time to Discharge) | 33 days | Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33 |
| ICU Stay Length | 33 days | Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33. |
| Cumulative Mortality Rate Through Day 33 | 33 days | Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33 |
| Number of Subjects With Severe Disease Progression | 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. |
Countries
Russia, Ukraine, United States
Participant flow
Recruitment details
A total of 207 patients were enrolled between June 2020 and February 2021 at 23 sites across the United States, Russia and Ukraine
Participants by arm
| Arm | Count |
|---|---|
| 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 | 105 |
| Saline Solution Saline solution placebo group | 102 |
| Total | 207 |
Baseline characteristics
| Characteristic | Octagam 10% | Saline Solution | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years | 58.9 years | 58.2 years |
| Body Mass Index (BMI)(kg/m^2) | 31.47 kg/m^2 STANDARD_DEVIATION 5.57 | 32.33 kg/m^2 STANDARD_DEVIATION 6.322 | 31.88 kg/m^2 STANDARD_DEVIATION 5.934 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 21 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 76 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 5 Participants | 14 Participants |
| Race (NIH/OMB) White | 87 Participants | 89 Participants | 176 Participants |
| Sex: Female, Male Female | 40 Participants | 48 Participants | 88 Participants |
| Sex: Female, Male Male | 65 Participants | 54 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 105 | 6 / 102 |
| other Total, other adverse events | 49 / 105 | 40 / 100 |
| serious Total, serious adverse events | 15 / 105 | 12 / 100 |
Outcome results
Primary
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
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.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Octagam 10% | Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7 | 89 Participants |
| Placebo | Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7 | 82 Participants |
Secondary
Cumulative Duration of Invasive Mechanical Venitlation (IMV)
Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33
Time frame: 33 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octagam 10% | Cumulative Duration of Invasive Mechanical Venitlation (IMV) | 2.7 days | Standard Deviation 8.05 |
| Placebo | Cumulative Duration of Invasive Mechanical Venitlation (IMV) | 1.6 days | Standard Deviation 5.95 |
Secondary
Cumulative Mortality Rate Through Day 33
Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33
Time frame: 33 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Octagam 10% | Cumulative Mortality Rate Through Day 33 | 12 Participants |
| Placebo | Cumulative Mortality Rate Through Day 33 | 6 Participants |
Secondary
ICU Stay Length
Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33.
Time frame: 33 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Octagam 10% | ICU Stay Length | 4.6 days | Standard Deviation 10.08 |
| Placebo | ICU Stay Length | 3.9 days | Standard Deviation 8.83 |
Secondary
Length of Hospital Stay (Time to Discharge)
Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33
Time frame: 33 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octagam 10% | Length of Hospital Stay (Time to Discharge) | 12 days |
| Placebo | Length of Hospital Stay (Time to Discharge) | 11 days |
Secondary
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14
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.
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Octagam 10% | Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14 | 86 Participants |
| Placebo | Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14 | 83 Participants |
Secondary
Number of Subjects With Severe Disease Progression
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.
Time frame: 33 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Octagam 10% | Number of Subjects With Severe Disease Progression | 15 Participants |
| Placebo | Number of Subjects With Severe Disease Progression | 12 Participants |
Post Hoc
Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire)
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
Time frame: 1-year post-study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| 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 3 - None of the above | 43 participants |
| 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 - Missing Answer | 17 participants |
| 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 4 - Other | 21 participants |
| 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 2 - Much Worse | 3 participants |
| 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 - Poor | 1 participants |
| 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 2 - Somewhat Worse | 12 participants |
| 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 4 - Similar to those during the COVID-19 hospitalization | 5 participants |
| 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 2 - The Same | 44 participants |
| 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 | 3 participants |
| 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 2 - Somewhat Better | 5 participants |
| 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 5 - Yes | 44 participants |
| 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 2 - Much Better | 3 participants |
| 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 - Fair | 14 participants |
| 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 2 - Missing Answer | 17 participants |
| 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 5 - No | 23 participants |
| 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 3 - Been Hospitalized | 2 participants |
| 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 - Very Good | 13 participants |
| 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 3 - Sought consultation from HCP | 22 participants |
| 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 6 - Yes | 44 participants |
| 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 3 - Experienced deterioration of your health without HCP documentation | 0 participants |
| 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 - Good | 36 participants |
| 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 6 - No | 23 participants |
| 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 3 - Missing answer | 17 participants |
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)
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
Time frame: 3 months post-study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| 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 6 - No | 32 participants |
| 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 1 - Poor | 1 participants |
| 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 1 - Fair | 24 participants |
| 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 1 - Good | 30 participants |
| 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 1 - Very Good | 15 participants |
| 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 1 - Excellent | 5 participants |
| 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 1 - Missing Answer | 9 participants |
| 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 | 5 participants |
| 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 - Somewhat Worse | 29 participants |
| 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 - The Same | 29 participants |
| 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 - Somewhat Better | 7 participants |
| 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 Better | 5 participants |
| 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 - Missing Answer | 9 participants |
| 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 3 - Been Hospitalized | 7 participants |
| 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 3 - Sought consultation from HCP | 25 participants |
| 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 3 - Experienced deterioration of your health without HCP documentation | 8 participants |
| 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 3 - None of the above | 38 participants |
| 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 3 - Missing answer | 9 participants |
| 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 4 - Other | 27 participants |
| 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 4 - Similar to those during the COVID-19 hospitalization | 13 participants |
| 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 5 - Yes | 49 participants |
| 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 5 - No | 26 participants |
| 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 6 - Yes | 42 participants |
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)
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
Time frame: 6 months post-study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| 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 2 - Missing Answer | 16 participants |
| 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 4 - Other | 18 participants |
| 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 - Poor | 0 participants |
| 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 3 - Been Hospitalized | 3 participants |
| 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 - Fair | 20 participants |
| 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 5 - No | 25 participants |
| 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 - Good | 22 participants |
| 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 3 - Sought consultation from HCP | 16 participants |
| 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 | 19 participants |
| 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 4 - Similar to those during the COVID-19 hospitalization | 4 participants |
| 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 - Excellent | 7 participants |
| 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 - Missing Answer | 16 participants |
| 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 3 - Experienced deterioration of your health without HCP documentation | 0 participants |
| 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 2 - Much Worse | 4 participants |
| 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 6 - No | 29 participants |
| 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 2 - Somewhat Worse | 12 participants |
| 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 3 - None of the above | 49 participants |
| 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 2 - The Same | 38 participants |
| 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 5 - Yes | 43 participants |
| 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 2 - Somewhat Better | 9 participants |
| 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 3 - Missing answer | 16 participants |
| 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 2 - Much Better | 5 participants |
| 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 6 - Yes | 39 participants |
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)
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
Time frame: 9 months post-study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| Octagam 10% | 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 |
| 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 6 - No | 25 participants |
| 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 |
| 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 - Fair | 19 participants |
| 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 - Good | 31 participants |
| 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 - Very Good | 14 participants |
| 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 - Excellent | 4 participants |
| 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 - Missing Answer | 15 participants |
| 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 2 - Much Worse | 4 participants |
| 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 2 - Somewhat Worse | 15 participants |
| 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 2 - The Same | 38 participants |
| 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 2 - Somewhat Better | 6 participants |
| 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 2 - Much Better | 6 participants |
| 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 2 - Missing Answer | 15 participants |
| 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 3 - Been Hospitalized | 2 participants |
| 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 3 - Sought consultation from HCP | 24 participants |
| 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 3 - Experienced deterioration of your health without HCP documentation | 1 participants |
| 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 3 - None of the above | 43 participants |
| 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 3 - Missing answer | 15 participants |
| 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 4 - Other | 23 participants |
| 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 4 - Similar to those during the COVID-19 hospitalization | 4 participants |
| 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 5 - Yes | 44 participants |
| 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 5 - No | 25 participants |
| 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 6 - Yes | 44 participants |