Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19) (NCT NCT04480424)
NCT ID: NCT04480424
Last Updated: 2022-10-07
Results Overview
All-cause mortality rate is percentage of participants in each treatment group who experienced mortality up to Day 29.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Up to Day 29
Results posted on
2022-10-07
Participant Flow
Participants were enrolled in the study at 18 study centers in the United States. The study was conducted from 17 September 2020 to 25 October 2021.
Participants with Coronavirus Disease 2019 (COVID-19) were randomized in 1:1 ratio to receive Standard Medical Treatment (SMT) or SMT plus a net total dose of Gamunex-C of 2 grams per kilogram (g/kg) (body weight) administered in divided doses over 4 to 5 consecutive days at the Principal Investigator's discretion. Maximum dose was capped at 160 g.
Participant milestones
| Measure |
GAMUNEX-C + Standard Medical Treatment
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
22
|
26
|
Reasons for withdrawal
| Measure |
GAMUNEX-C + Standard Medical Treatment
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Death
|
14
|
16
|
|
Overall Study
Reason not Specified
|
5
|
5
|
Baseline Characteristics
Number analyzed is number of participants with data available for Ethnicity.
Baseline characteristics by cohort
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
n=50 Participants
|
59.5 years
n=50 Participants
|
57.5 years
n=100 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=50 Participants
|
23 Participants
n=50 Participants
|
49 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=50 Participants
|
27 Participants
n=50 Participants
|
51 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=47 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
7 Participants
n=40 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
16 Participants
n=87 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=47 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
33 Participants
n=40 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
71 Participants
n=87 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=47 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
0 Participants
n=40 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
0 Participants
n=87 Participants • Number analyzed is number of participants with data available for Ethnicity.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
9 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=50 Participants
|
31 Participants
n=50 Participants
|
61 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=50 Participants
|
11 Participants
n=50 Participants
|
24 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Up to Day 29Population: The intent to treat (ITT) population included all participants who were randomized.
All-cause mortality rate is percentage of participants in each treatment group who experienced mortality up to Day 29.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
All-Cause Mortality Rate Through Day 29
|
28.0 Percentage of participants
|
32.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The ITT population included all participants who were randomized.
Percentage of participants who were discharged from ICU were recorded. Time to actual ICU discharge was defined as duration of actual ICU stay from Day 1 through Day 29.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Percentage of Participants With Actual Intensive Care Unit (ICU) Discharge Time
|
64 Percentage of participants
Interval 48.9 to 75.7
|
62 Percentage of participants
Interval 46.8 to 74.0
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The ITT population included all participants who were randomized.
Duration (number of days) of ICU stay from post-randomization through Day 29 was calculated based on ICU admission and discharge (actual and medical equivalence) dates.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
11.22 days
Interval 8.01 to 14.43
|
8.64 days
Interval 5.43 to 11.85
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The ITT population included all participants who were randomized.
Percentage of participants who were discharged from the hospital were recorded. Time to hospital discharge was defined as duration of hospitalization from Day 1 through Day 29.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Percentage of Participants With Actual Hospital Discharge Time
|
62 Percentage of participants
Interval 46.8 to 74.0
|
56 Percentage of participants
Interval 41.0 to 68.6
|
SECONDARY outcome
Timeframe: Up to Day 29Population: The ITT population included all participants who were randomized.
Duration (number of days) of any oxygen use from Day 1 through Day 29 was calculated based on the start/stop dates.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Duration of Any Oxygen Use From Day 1 Through Day 29
|
23.00 days
Interval 20.31 to 25.69
|
23.02 days
Interval 20.33 to 25.71
|
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: The ITT population included all participants who were randomized.
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Higher score indicated no severe illness. Mean change in Ordinal scale was evaluated by fitting a linear mixed-effects model for repeated measures (MMRM). The data is reported for average across all postbaseline.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Mean Change From Baseline in Ordinal Scale
|
-0.12 score on a scale
Interval -0.36 to 0.13
|
-0.17 score on a scale
Interval -0.42 to 0.08
|
SECONDARY outcome
Timeframe: Baseline, Day 29Population: The ITT population included all participants who were randomized.
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Higher score indicated no severe illness.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Absolute Change From Baseline in Ordinal Scale at Day 29
|
1.05 score on scale
Interval 0.72 to 1.38
|
0.65 score on scale
Interval 0.32 to 0.98
|
SECONDARY outcome
Timeframe: Days 15 and 29Population: The ITT population included all participants who were randomized. Number analyzed are the number of participants with data available for analysis at the given timepoint.
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 15, Death
|
18.2 percentage of participants
|
27.3 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 15, Hospitalized, on invasive mechanical ventilation or ECMO
|
31.8 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 15, Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
11.4 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 15, Hospitalized, requiring supplemental oxygen
|
18.2 percentage of participants
|
15.9 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 15, Hospitalized, not requiring supplemental oxygen
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 15, Not hospitalized, limitation on activities
|
13.6 percentage of participants
|
20.5 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 15, Not hospitalized, no limitations on activities
|
6.8 percentage of participants
|
2.3 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 29, Death
|
31.7 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 29, Hospitalized, on invasive mechanical ventilation or ECMO
|
14.6 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 29, Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
2.4 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 29, Hospitalized, requiring supplemental oxygen
|
4.9 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 29, Hospitalized, not requiring supplemental oxygen
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 29, Not hospitalized, limitation on activities
|
24.4 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Day 29, Not hospitalized, no limitations on activities
|
19.5 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1, 5, 15 and 29Population: The ITT population included all participants who were randomized.
Acute Respiratory Distress Syndrome was defined based on Berlin criteria (chest imaging, origin of edema, oxygenation).
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Percentage of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
Day 1
|
94.0 percentage of participants
|
96.0 percentage of participants
|
|
Percentage of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
Day 5
|
93.9 percentage of participants
|
94.0 percentage of participants
|
|
Percentage of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
Day 15
|
79.4 percentage of participants
|
61.3 percentage of participants
|
|
Percentage of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
Day 29
|
28.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1, 5, 15 and 29Population: The ITT population is included all participants who were randomized.
ARDS was defined by Berlin's criteria as: 1) Timing is usually within 1 week of a known clinical insult or new or worsening respiratory symptoms 2) Chest imaging: bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules 3) Respiratory failure not fully explained by cardiac failure or fluid overload Need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present 4) Oxygenation: Mild 200 mm Hg \< partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mm Hg with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥ 5 cm H2Oc; Moderate 100 mm Hg \< PaO2/FIO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O; Severe PaO2/FIO2 ≤100 mm Hg with PEEP ≥ 5 cm H2O.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 1: Mild
|
4.0 percentage of participants
|
4.0 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 1: Moderate
|
50.0 percentage of participants
|
58.0 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 1: Severe
|
40.0 percentage of participants
|
34.0 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 5: Mild
|
18.4 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 5: Moderate
|
42.9 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 5: Severe
|
32.7 percentage of participants
|
22.0 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 15: Mild
|
41.2 percentage of participants
|
9.7 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 15: Moderate
|
14.7 percentage of participants
|
35.5 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 15: Severe
|
23.5 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 29: Mild
|
4.0 percentage of participants
|
23.8 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 29: Moderate
|
12.0 percentage of participants
|
4.8 percentage of participants
|
|
Percentage of Participants Who Develop ARDS Distributed by Severity
Day 29: Severe
|
12.0 percentage of participants
|
4.8 percentage of participants
|
SECONDARY outcome
Timeframe: Days 5, 15, and 29Population: The ITT population included all participants who were randomized.
SOFA score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours SOFA score ranges from 0 (no organ dysfunction) to 24 (highest possible score / organ dysfunction). Higher score indicated severe illness.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 5, Day 15, and Day 29
Change from Baseline at Day 5
|
0.34 score on a scale
Interval -0.28 to 0.95
|
-0.07 score on a scale
Interval -0.68 to 0.55
|
|
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 5, Day 15, and Day 29
Change from Baseline at Day 15
|
0.20 score on a scale
Interval -1.14 to 1.55
|
0.30 score on a scale
Interval -1.22 to 1.82
|
|
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 5, Day 15, and Day 29
Change from Baseline at Day 29
|
-0.87 score on a scale
Interval -2.58 to 0.83
|
-0.95 score on a scale
Interval -2.98 to 1.08
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: The ITT population included all participants who were randomized.
NEWS is clinical scoring developed to improve detection of deterioration in ill participant. It is based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure (BP), pulse rate, level of consciousness, and temperature. A score of 0 and 2 was allocated to supplemental oxygen, 0 and 3 for level of consciousness and score of 0, 1, 2 and 3 for remaining parameters (i.e. respiration rate, oxygen saturation, systolic BP, pulse rate and temperature) where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS score ranged from 0 to 20, with higher scores meaning more severity/higher risk.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Change From Baseline in National Early Warning Score (NEWS)
|
-2.56 score on a scale
Interval -3.56 to -1.57
|
-2.62 score on a scale
Interval -3.71 to -1.54
|
SECONDARY outcome
Timeframe: Day 29Population: The ITT population included all participants who were randomized.
Percentage of participants who achieved clinical response (i.e the NEWS score ≤2 maintained for 24 hours from Day 1 through Day 29) was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 Participants
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 Participants
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Percentage of Participants Achieving Clinical Response: NEWS ≤ 2 Maintained for 24 Hours
|
32.9 percentage of participants
Interval 18.5 to 54.1
|
28.2 percentage of participants
Interval 14.8 to 49.5
|
Adverse Events
GAMUNEX-C + Standard Medical Treatment
Serious events: 27 serious events
Other events: 42 other events
Deaths: 16 deaths
Standard Medical Treatment
Serious events: 23 serious events
Other events: 44 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 participants at risk
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 participants at risk
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
1/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Torsade de pointes
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
General disorders
Multiple organ dysfunction syndrome
|
4.0%
2/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
COVID-19
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Septic shock
|
8.0%
4/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Urosepsis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
International normalised ratio increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Meningism
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
16.0%
8/50 • From the start of the study up to Day 90
|
10.0%
5/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
2/50 • From the start of the study up to Day 90
|
6.0%
3/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.0%
2/50 • From the start of the study up to Day 90
|
12.0%
6/50 • From the start of the study up to Day 90
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Distributive shock
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Hypotension
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
Other adverse events
| Measure |
GAMUNEX-C + Standard Medical Treatment
n=50 participants at risk
Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29.
|
Standard Medical Treatment
n=50 participants at risk
Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
6/50 • From the start of the study up to Day 90
|
12.0%
6/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.0%
3/50 • From the start of the study up to Day 90
|
8.0%
4/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/50 • From the start of the study up to Day 90
|
8.0%
4/50 • From the start of the study up to Day 90
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
2/50 • From the start of the study up to Day 90
|
10.0%
5/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Bradycardia
|
8.0%
4/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Cardiomyopathy
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Tachycardia
|
10.0%
5/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Eye disorders
Cataract
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Eye disorders
Eye disorder
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Constipation
|
8.0%
4/50 • From the start of the study up to Day 90
|
16.0%
8/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Ileus
|
6.0%
3/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Gastrointestinal disorders
Swollen tongue
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
General disorders
Catheter site haemorrhage
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
General disorders
Chest pain
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
General disorders
Fatigue
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
General disorders
Generalised oedema
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
General disorders
Oedema
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
General disorders
Oedema peripheral
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
General disorders
Pyrexia
|
6.0%
3/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
General disorders
Tachyphylaxis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Clostridium difficile colitis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Cystitis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Diverticulitis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Enterococcal bacteraemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Fungaemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Labyrinthitis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Oral candidiasis
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Oral herpes
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • From the start of the study up to Day 90
|
6.0%
3/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Pneumonia bacterial
|
8.0%
4/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Pneumonia escherichia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Pneumonia klebsiella
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Pneumonia serratia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Salpingitis
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Septic shock
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Injury, poisoning and procedural complications
Perineal injury
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.0%
1/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.0%
3/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Blood albumin decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Blood creatinine decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Blood pH increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Blood phosphorus decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Blood potassium increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Blood pressure increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Blood sodium decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Body temperature decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Body temperature increased
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
C-reactive protein increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Carbon dioxide increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Coombs direct test positive
|
6.0%
3/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Eosinophil count increased
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Fibrin D dimer increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Haematocrit decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Haemoglobin decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Heart rate abnormal
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Heart rate increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Neutrophil count increased
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Occult blood positive
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Platelet count decreased
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Investigations
Platelet count increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Red blood cell count decreased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Respiratory rate increased
|
8.0%
4/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Investigations
Serum ferritin increased
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
Transaminases increased
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Investigations
White blood cell count increased
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.0%
3/50 • From the start of the study up to Day 90
|
16.0%
8/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
4.0%
2/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
8.0%
4/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
6.0%
3/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.0%
2/50 • From the start of the study up to Day 90
|
8.0%
4/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
5/50 • From the start of the study up to Day 90
|
24.0%
12/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.0%
6/50 • From the start of the study up to Day 90
|
8.0%
4/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Encephalopathy
|
8.0%
4/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Metabolic encephalopathy
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Paraesthesia
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Seizure
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Tension headache
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Nervous system disorders
Toxic encephalopathy
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Agitation
|
4.0%
2/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50 • From the start of the study up to Day 90
|
6.0%
3/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Delirium
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Intensive care unit delirium
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Renal and urinary disorders
Acute kidney injury
|
8.0%
4/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Renal and urinary disorders
Haematuria
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Renal and urinary disorders
Renal failure
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
3/50 • From the start of the study up to Day 90
|
8.0%
4/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
4.0%
2/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
6.0%
3/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50 • From the start of the study up to Day 90
|
6.0%
3/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.0%
3/50 • From the start of the study up to Day 90
|
8.0%
4/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.0%
2/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Skin and subcutaneous tissue disorders
Skin maceration
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Surgical and medical procedures
Tracheostomy
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Distributive shock
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Haematoma
|
2.0%
1/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Hypertension
|
4.0%
2/50 • From the start of the study up to Day 90
|
4.0%
2/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Hypotension
|
22.0%
11/50 • From the start of the study up to Day 90
|
20.0%
10/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Jugular vein thrombosis
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Microembolism
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Shock
|
2.0%
1/50 • From the start of the study up to Day 90
|
0.00%
0/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
|
Vascular disorders
Vasodilatation
|
0.00%
0/50 • From the start of the study up to Day 90
|
2.0%
1/50 • From the start of the study up to Day 90
|
Additional Information
Rhonda Griffin
Scientific Innovation Office (SIO) Clinical Program Leader/Director Bioscience Clinical & Pharmacovigilance
Phone: +1 919 316 6693
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
- Publication restrictions are in place
Restriction type: OTHER