Trial Outcomes & Findings for Antithrombin III in Infectious Disease Caused by COVID-19 (NCT NCT04899232)
NCT ID: NCT04899232
Last Updated: 2022-09-07
Results Overview
As measured by the International Society of Thrombosis and Haemostasis Disseminated Intravascular Coagulation scale (ISTH DIC) which has a total score ranging from 0-8 with a score of 5 and higher indicating overt DIC.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Baseline, Day 9
Results posted on
2022-09-07
Participant Flow
Participant death while on the study is considered completion of study.
Participant milestones
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Screening Period
STARTED
|
20
|
20
|
12
|
|
Screening Period
COMPLETED
|
15
|
20
|
12
|
|
Screening Period
NOT COMPLETED
|
5
|
0
|
0
|
|
Treatment Period
STARTED
|
15
|
20
|
12
|
|
Treatment Period
COMPLETED
|
15
|
20
|
12
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Screening Period
Physician Decision
|
1
|
0
|
0
|
|
Screening Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
Screening Period
Participant discharged before receiving intervention
|
3
|
0
|
0
|
Baseline Characteristics
Antithrombin III in Infectious Disease Caused by COVID-19
Baseline characteristics by cohort
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=20 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=20 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 9Population: Not all participants were able to complete the assessments required for evaluation of the DIC score.
As measured by the International Society of Thrombosis and Haemostasis Disseminated Intravascular Coagulation scale (ISTH DIC) which has a total score ranging from 0-8 with a score of 5 and higher indicating overt DIC.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=15 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Change in ISTH DIC Score
|
0.27 score on a scale
Standard Deviation 1.71
|
0 score on a scale
Standard Deviation 1.73
|
0 score on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: Baseline, Day 9Population: Not all participants were able to complete the assessments required for the evaluation of the D-dimer.
D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=15 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Change in D-Dimer Levels
|
-1.97 mcg/ml DDU
Standard Deviation 5.60
|
0.4 mcg/ml DDU
Standard Deviation 3.18
|
0.25 mcg/ml DDU
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: Baseline, Day 9Population: Not all participants were able to complete the assessments required for evaluation of Fibrinogen levels.
Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=15 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Change in Fibrinogen Levels
|
-102.1 mg/dL
Standard Deviation 233.7
|
-123 mg/dL
Standard Deviation 215.1
|
-111 mg/dL
Standard Deviation 307.5
|
SECONDARY outcome
Timeframe: Baseline, Day 9Population: Not all participants were able to complete the assessments required for evaluation of the Prothrombin Time levels.
Prothrombin time assessed from blood samples will be evaluated in seconds.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=15 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Change in Prothrombin Time
|
0.01 Seconds
Standard Deviation 2.07
|
0.31 Seconds
Standard Deviation 1.27
|
0.59 Seconds
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Up to 60 daysLength of Hospital Stay reported in days.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=20 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Length of Hospital Stay
|
13 Days
Standard Deviation 15.1
|
6 Days
Standard Deviation 8.35
|
8.5 Days
Standard Deviation 9.46
|
SECONDARY outcome
Timeframe: Up to 60 daysThe number of participants with reported death.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=20 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Mortality Rate
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 60 daysPulmonary Function will be reported as the mean days the participant was on any of the following: mechanical ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) use.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=20 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Pulmonary Function
|
1.33 Days
Standard Deviation 5.16
|
2.2 Days
Standard Deviation 6.70
|
3.08 Days
Standard Deviation 6.97
|
SECONDARY outcome
Timeframe: Baseline, Day9Population: Not all participants were able to complete the assessments required for evaluation of the SOFA score.
Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=14 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=15 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Change in SOFA Scores
|
0.43 score on a scale
Standard Deviation 3.41
|
1.23 score on a scale
Standard Deviation 3.33
|
0.64 score on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: Baseline, Day 9Population: Not all participants were able to complete the assessments required for evaluation of the SOFA sub score.
SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=15 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Change in SOFA Respiratory Sub Score
|
-0.67 score on a scale
Standard Deviation 0.98
|
-0.07 score on a scale
Standard Deviation 0.70
|
-0.17 score on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Up to 60 daysNumber of events of venous thromboembolisms from admission to hospital discharge.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=20 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Number of Events of Venous Thromboembolism
|
0 Events
|
0 Events
|
3 Events
|
SECONDARY outcome
Timeframe: Up to 60 daysNumber of events of major bleeding from admission to hospital discharge.
Outcome measures
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 Participants
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=20 Participants
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 More Than 100% With SOC Only
n=12 Participants
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
|
|---|---|---|---|
|
Number of Events of Major Bleeding
|
0 events
|
0 events
|
2 events
|
Adverse Events
AT3 Less Than 100% With SOC Plus AT3 Supplement
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
AT3 Less Than 100% With SOC Only
Serious events: 0 serious events
Other events: 5 other events
Deaths: 3 deaths
AT3 of 100% or More, With SOC Only
Serious events: 0 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AT3 Less Than 100% With SOC Plus AT3 Supplement
n=15 participants at risk
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive up to 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
Antithrombin III: A daily dose from 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight and current antithrombin II level, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
|
AT3 Less Than 100% With SOC Only
n=20 participants at risk
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
|
AT3 of 100% or More, With SOC Only
n=12 participants at risk
Participants in this group, with endogenous Antithrombin III 100% or more, will receive SOC treatment only.
|
|---|---|---|---|
|
General disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Number of events 1 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Renal and urinary disorders
Acute Kidney Injury
|
13.3%
2/15 • Number of events 2 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
33.3%
4/12 • Number of events 4 • 60 days
|
|
General disorders
Shock
|
6.7%
1/15 • Number of events 1 • 60 days
|
10.0%
2/20 • Number of events 2 • 60 days
|
16.7%
2/12 • Number of events 2 • 60 days
|
|
Cardiac disorders
Heart Failure with reduced Ejection Fraction
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Renal and urinary disorders
Ureterovesical Junction (UVJ) Calculus
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
General disorders
Epistaxis
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Gout
|
6.7%
1/15 • Number of events 1 • 60 days
|
0.00%
0/20 • 60 days
|
0.00%
0/12 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Respiratory Failure
|
6.7%
1/15 • Number of events 1 • 60 days
|
15.0%
3/20 • Number of events 3 • 60 days
|
33.3%
4/12 • Number of events 4 • 60 days
|
|
Cardiac disorders
Pulseless Electrical Activity
|
6.7%
1/15 • Number of events 1 • 60 days
|
15.0%
3/20 • Number of events 3 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Incidental Pulmonary Neoplasm
|
6.7%
1/15 • Number of events 1 • 60 days
|
0.00%
0/20 • 60 days
|
0.00%
0/12 • 60 days
|
|
Skin and subcutaneous tissue disorders
Necrotic Blister
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
16.7%
2/12 • Number of events 2 • 60 days
|
|
Nervous system disorders
Critical Illness Polyneuropathy
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Number of events 1 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
16.7%
2/12 • Number of events 2 • 60 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Cardiac disorders
Hypotension
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Immune system disorders
Leukocytosis
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Cardiac disorders
Asystole
|
6.7%
1/15 • Number of events 1 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pneumothorax
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Blood and lymphatic system disorders
Elevated D-Dimer
|
6.7%
1/15 • Number of events 1 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Severe Acute Respiratory Distress Syndrome (ARDS)
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Metabolism and nutrition disorders
Alkalemia
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Right Pneumothorax
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Subcutaneous Emphysema w/ Pneumomdiastinum
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.7%
1/15 • Number of events 1 • 60 days
|
0.00%
0/20 • 60 days
|
0.00%
0/12 • 60 days
|
|
Renal and urinary disorders
Dialysis
|
6.7%
1/15 • Number of events 1 • 60 days
|
0.00%
0/20 • 60 days
|
0.00%
0/12 • 60 days
|
|
Blood and lymphatic system disorders
Thromocytopenia
|
6.7%
1/15 • Number of events 1 • 60 days
|
0.00%
0/20 • 60 days
|
0.00%
0/12 • 60 days
|
|
General disorders
Congestion
|
0.00%
0/15 • 60 days
|
5.0%
1/20 • Number of events 1 • 60 days
|
0.00%
0/12 • 60 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
|
Infections and infestations
MSSA Bacteremia
|
0.00%
0/15 • 60 days
|
0.00%
0/20 • 60 days
|
8.3%
1/12 • Number of events 1 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place