Trial Outcomes & Findings for Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19) (NCT NCT04409509)
NCT ID: NCT04409509
Last Updated: 2022-01-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
From randomization to Day 28
Results posted on
2022-01-24
Participant Flow
Participant milestones
| Measure |
Placebo
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
63
|
|
Overall Study
COMPLETED
|
48
|
43
|
|
Overall Study
NOT COMPLETED
|
13
|
20
|
Reasons for withdrawal
| Measure |
Placebo
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Overall Study
Failure to meet randomization requirement
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
11
|
10
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Randomized by mistake
|
0
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
Baseline characteristics by cohort
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 12.74 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 14.61 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 13.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
63 participants
n=7 Participants
|
124 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to Day 28Population: Intent-to-treat Analysis Set (ITT) comprises all subjects who were randomly assigned to treatment and who were assigned randomization numbers.
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
The Percent of Participants With Tracheal Intubation or Death Prior to Tracheal Intubation
|
26.2 percentage of participants
|
22.2 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants With Death From All Causes
|
18.0 percentage of participants
|
17.5 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants With Tracheal Intubation
|
24.6 percentage of participants
|
17.5 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Number of Participants With ≥ 2-Point Improvement Compared to Baseline on National Institute of Allergy and Infectious Diseases (NIAID) Ordinal Scale
|
44 participants
|
42 participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants With ≥ 2-Point Improvement Compared to Baseline on NIAID
|
72.1 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28Population: ITT
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Death
|
11 participants
|
11 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, Not Requiring Supplemental Oxygen - Requiring Ongoing Medical Care
|
0 participants
|
0 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, on Invasive Mechanical Ventilation or ECMO
|
2 participants
|
1 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, on Non-invasive Ventilation or High-flow Oxygen Devices
|
2 participants
|
0 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, Requiring Supplemental Oxygen
|
1 participants
|
2 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, Not Requiring Supplemental Oxygen - no Longer Requiring Medical Care
|
0 participants
|
0 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Not Hospitalized, Limitation on Activities and/or Requiring Home Oxygen
|
14 participants
|
11 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Not Hospitalized, no Limitations on Activities
|
25 participants
|
26 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Not Done
|
5 participants
|
6 participants
|
|
Number of Participants Within Each of the Categories of the NIAID at End of Study
Missing
|
1 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Day 28Population: ITT
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Death
|
18.0 percentage of participants
|
17.5 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, on Invasive Mechanical Ventilation or ECMO
|
3.3 percentage of participants
|
1.6 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, on Non-invasive Ventilation or High-flow Oxygen Devices
|
3.3 percentage of participants
|
0 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, Requiring Supplemental Oxygen
|
1.6 percentage of participants
|
3.2 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, Not Requiring Supplemental Oxygen - Requiring Ongoing Medical Care
|
0 percentage of participants
|
0 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Hospitalized, Not Requiring Supplemental Oxygen - no Longer Requiring Medical Care
|
0 percentage of participants
|
0 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Not Hospitalized, Limitation on Activities and/or Requiring Home Oxygen
|
23.0 percentage of participants
|
17.5 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Not Hospitalized, no Limitations on Activities
|
41.0 percentage of participants
|
41.3 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Not Done
|
8.2 percentage of participants
|
9.5 percentage of participants
|
|
Percent of Participants Within Each of the Categories of the NIAID at End of Study
Missing
|
1.6 percentage of participants
|
9.5 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants Requiring Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
|
16.4 percentage of participants
|
19.0 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT. None of the enrolled subjects required the use of ECMO during their participation in this study. Therefore, no data to report for this outcome measure.
None of the enrolled subjects required the use of ECMO during their participation in this study. Therefore, no data to report for this outcome measure.
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants Requiring Extracorporeal Membrane Oxygenation (ECMO)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants Requiring High-Flow Nasal Cannula (HFNC)
|
18.0 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT. Participants with missing values were not included in the analysis.
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 (normal function) to 4 (most abnormal) with a total score ranging from 0 to 24. A high total SOFA score have been shown to be related to a worse outcome.
Outcome measures
| Measure |
Placebo
n=50 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=45 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Maximum Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score
|
0.5 score on a scale
Standard Deviation 1.54
|
0.1 score on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT. Participants with missing values were not included in the analysis.
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 (normal function) to 4 (most abnormal) with a total score ranging from 0 to 24. A high total SOFA score have been shown to be related to a worse outcome.
Outcome measures
| Measure |
Placebo
n=15 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=12 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Change From Baseline in SOFA Total Score
|
-1.0 score on a scale
Standard Deviation 1.77
|
-1.3 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: From randomization to Day 28Population: ITT. Participants with missing values were not included in the analysis.
The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each system is scored from 0 (normal function) to 4 (most abnormal) with a total score ranging from 0 to 24. A high total SOFA score have been shown to be related to a worse outcome.
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Change From Baseline in the Individual Components of SOFA Score
Respiration Score
|
-0.6 score on a scale
Standard Deviation 1.32
|
-1.2 score on a scale
Standard Deviation 1.16
|
|
Change From Baseline in the Individual Components of SOFA Score
Coagulation Score
|
-0.1 score on a scale
Standard Deviation 0.42
|
0.4 score on a scale
Standard Deviation 1.12
|
|
Change From Baseline in the Individual Components of SOFA Score
Liver Score
|
0.0 score on a scale
Standard Deviation 0.22
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Change From Baseline in the Individual Components of SOFA Score
Cardiovascular Score
|
0.4 score on a scale
Standard Deviation 1.65
|
0.5 score on a scale
Standard Deviation 1.35
|
|
Change From Baseline in the Individual Components of SOFA Score
Central Nervous System Score
|
0.0 score on a scale
Standard Deviation 0.00
|
0.0 score on a scale
Standard Deviation 0.19
|
|
Change From Baseline in the Individual Components of SOFA Score
Renal Score
|
0.3 score on a scale
Standard Deviation 0.93
|
0.5 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: From randomization to Day 28 (+/- 2 days)Population: ITT
Outcome measures
| Measure |
Placebo
n=61 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=63 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Length of Hospital Stay
|
7.00 Days
Interval 0.0 to 29.0
|
6.50 Days
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 or placebo administrationPopulation: The Safety Analysis Set (SA) comprises all subjects in the ITT Analysis Set who receive any amount of CSL312 or placebo.
Outcome measures
| Measure |
Placebo
n=59 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
|
40 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 or placebo administrationPopulation: SA
Outcome measures
| Measure |
Placebo
n=59 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants Experiencing AEs
|
67.8 percentage of participants
|
60.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 or placebo administrationPopulation: SA
Outcome measures
| Measure |
Placebo
n=59 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Number of Participants Experiencing Serious Adverse Events (SAEs)
|
19 participants
|
20 participants
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 or placebo administrationPopulation: SA
Outcome measures
| Measure |
Placebo
n=59 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants Experiencing SAEs
|
32.2 percentage of participants
|
34.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 or placebo administrationPopulation: SA
Outcome measures
| Measure |
Placebo
n=59 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 or placebo administrationPopulation: SA
Outcome measures
| Measure |
Placebo
n=59 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Percent of Participants With AESIs
|
10.2 percentage of participants
|
8.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 or placebo administrationPopulation: The pharmacodynamic (PD) Analysis Set will comprise all subjects in the Safety Analysis Set who received any amount of CSL312 or placebo and have ≥ 1 blood sample available for analysis of biomarkers.
Outcome measures
| Measure |
Placebo
n=59 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 Participants
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Number of Participants With Anti-CSL312 Antibodies
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 administrationPopulation: The pharmacokinetic (PK) Analysis Set will comprise all subjects in the Safety Analysis Set who received any amount of CSL312 or placebo and have ≥ 1 blood sample available for CSL312 concentration measurement.
Outcome measures
| Measure |
Placebo
n=57 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of CSL312
|
147.335 ug/mL
Standard Deviation 77.1286
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 administrationPopulation: PK
Outcome measures
| Measure |
Placebo
n=57 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of CSL312
|
0.667 hours
Interval 0.28 to 139.97
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 administrationPopulation: PK
Outcome measures
| Measure |
Placebo
n=57 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-Last) of CSL312
|
15806.644 h*ug/mL
Standard Deviation 9393.6295
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days after CSL312 administrationPopulation: PK. Participants with missing values were not included in the analysis.
Outcome measures
| Measure |
Placebo
n=9 Participants
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Terminal Half-life (T1/2) of CSL312
|
226.165 hours
Standard Deviation 102.6690
|
—
|
Adverse Events
Placebo
Serious events: 19 serious events
Other events: 21 other events
Deaths: 11 deaths
CSL312
Serious events: 20 serious events
Other events: 18 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Placebo
n=59 participants at risk
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 participants at risk
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.9%
7/59 • Number of events 8 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
10.3%
6/58 • Number of events 6 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
6.9%
4/58 • Number of events 5 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
6.9%
4/58 • Number of events 4 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.4%
2/59 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
3.4%
2/58 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
5.2%
3/58 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Vascular disorders
Hypotension
|
5.1%
3/59 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Vascular disorders
Arterial thrombosis
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Vascular disorders
Venous thrombosis
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Septic shock
|
6.8%
4/59 • Number of events 4 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Sepsis
|
3.4%
2/59 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Enterobacter bacteraemia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Enterobacter pneumonia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Pneumonia escherichia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Pneumonia streptococcal
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Cardiac disorders
Cardiac arrest
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
5.2%
3/58 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Nervous system disorders
Cerebellar infarction
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Nervous system disorders
Cerebral infarction
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Nervous system disorders
Haemorrhagic stroke
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
2/59 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
General disorders
Asthenia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.7%
1/59 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
Other adverse events
| Measure |
Placebo
n=59 participants at risk
CSL312 diluent administered intravenously
Placebo: CSL312 diluent administered intravenously
|
CSL312
n=58 participants at risk
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
Garadacimab, Factor XIIa Antagonist Monoclonal Antibody: Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.5%
5/59 • Number of events 5 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
8.6%
5/58 • Number of events 5 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.1%
3/59 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
3.4%
2/58 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.1%
3/59 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
3.4%
2/58 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Cardiac disorders
Atrial fibrillation
|
8.5%
5/59 • Number of events 5 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
3.4%
2/58 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/59 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
5.2%
3/58 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Investigations
Transaminases increased
|
6.8%
4/59 • Number of events 4 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Investigations
Fibrin D dimer increased
|
5.1%
3/59 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
1.7%
1/58 • Number of events 1 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Vascular disorders
Hypotension
|
10.2%
6/59 • Number of events 6 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
3.4%
2/58 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.2%
6/59 • Number of events 6 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Infections and infestations
Septic shock
|
3.4%
2/59 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
5.2%
3/58 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Psychiatric disorders
Anxiety
|
3.4%
2/59 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
5.2%
3/58 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.1%
3/59 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
3.4%
2/58 • Number of events 2 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
5.1%
3/59 • Number of events 3 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
0.00%
0/58 • Up to 28 days per participant after CSL312 or placebo administration
All-Cause mortality uses ITT set and treatment emergent adverse events uses the safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place