Trial Outcomes & Findings for Canakinumab in Covid-19 Cardiac Injury (The Three C Study) (NCT NCT04365153)
NCT ID: NCT04365153
Last Updated: 2021-04-15
Results Overview
Number of patients with either an improvement of two points on a seven category ordinal scale or discharge from the hospital
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Up to day 14
Results posted on
2021-04-15
Participant Flow
Participant milestones
| Measure |
High Dose Intervention
600 mg of canakinumab (8 mg/kg for patients \</= 40 kg)
Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Low Dose Intervention
300 mg of canakinumab (4 mg/kg for patients \</= 40 kg)
Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Control
Placebo
Placebos: 250 mL of 5% dextrose infused IV over 2 hours
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
16
|
|
Overall Study
COMPLETED
|
15
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Canakinumab in Covid-19 Cardiac Injury (The Three C Study)
Baseline characteristics by cohort
| Measure |
High Dose Intervention
n=15 Participants
600 mg of canakinumab (8 mg/kg for patients \</= 40 kg)
Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Low Dose Intervention
n=14 Participants
300 mg of canakinumab (4 mg/kg for patients \</= 40 kg)
Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Control
n=16 Participants
Placebo
Placebos: 250 mL of 5% dextrose infused IV over 2 hours
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.4 years
n=5 Participants
|
70.7 years
n=7 Participants
|
68.2 years
n=5 Participants
|
68.8 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African-American
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
BMI
|
29.2 kg/m^2
n=5 Participants
|
28.3 kg/m^2
n=7 Participants
|
29.2 kg/m^2
n=5 Participants
|
28.8 kg/m^2
n=4 Participants
|
|
Diabetes mellitus
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Hypertension
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Hyperlipidemia
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Coronary Artery Disease
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Stroke
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Atrial fibrillation or flutter
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
COPD
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Chronic kidney disease
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Current or former smoker
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Time from symptoms onset to randomization
|
6 days
n=5 Participants
|
9 days
n=7 Participants
|
6 days
n=5 Participants
|
7 days
n=4 Participants
|
|
Dyspnea
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Temperature
|
36.8 degrees Celsius
n=5 Participants
|
37.4 degrees Celsius
n=7 Participants
|
36.8 degrees Celsius
n=5 Participants
|
36.9 degrees Celsius
n=4 Participants
|
|
Hospitalized requiring invasive mechanical ventilation
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Hospitalized requiring nasal high-flow oxygen or non-invasive ventilation, or both
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Hospitalized requiring supplemental oxygen
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Hospitalized, not requiring supplemental oxygen
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Baseline PaO2/FiO2 ratio
|
148 ratio
n=5 Participants
|
160 ratio
n=7 Participants
|
117 ratio
n=5 Participants
|
148 ratio
n=4 Participants
|
|
Baseline SOFA scores (SOFA: Sequential organ failure assessment)
|
3 score on a scale
n=5 Participants
|
2 score on a scale
n=7 Participants
|
4 score on a scale
n=5 Participants
|
3 score on a scale
n=4 Participants
|
|
Corticosteroids
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Remdesivir
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
High sensitivity troponin T (ng/L) (reference range <12 ng/L)
|
21 ng/L
n=5 Participants
|
25 ng/L
n=7 Participants
|
32 ng/L
n=5 Participants
|
22 ng/L
n=4 Participants
|
|
N-terminal pro B-type natriuretic peptide (pg/mL) (reference range <125 pg/mL)
|
371 pg/mL
n=5 Participants
|
372 pg/mL
n=7 Participants
|
810 pg/mL
n=5 Participants
|
479 pg/mL
n=4 Participants
|
|
C reactive protein (mg/dL) (reference range 0.0-0.4 mg/dL)
|
12.7 mg/dL
n=5 Participants
|
12.2 mg/dL
n=7 Participants
|
17.6 mg/dL
n=5 Participants
|
15.3 mg/dL
n=4 Participants
|
|
Lymphocyte count (reference range 1.0-4.0 k/uL)
|
0.8 k/uL
n=5 Participants
|
0.7 k/uL
n=7 Participants
|
0.5 k/uL
n=5 Participants
|
0.7 k/uL
n=4 Participants
|
|
Ferritin (ng/mL)(reference range 14.7-205.1 ng/mL)
|
740 ng/mL
n=5 Participants
|
998 ng/mL
n=7 Participants
|
1246 ng/mL
n=5 Participants
|
1015 ng/mL
n=4 Participants
|
|
D-dimer (ng/mL)(reference range <500 ng/mL)
|
1795 ng/mL
n=5 Participants
|
950 ng/mL
n=7 Participants
|
1500 ng/mL
n=5 Participants
|
1320 ng/mL
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to day 14Number of patients with either an improvement of two points on a seven category ordinal scale or discharge from the hospital
Outcome measures
| Measure |
High Dose Intervention
n=15 Participants
600 mg of canakinumab (8 mg/kg for patients \</= 40 kg)
Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Low Dose Intervention
n=14 Participants
300 mg of canakinumab (4 mg/kg for patients \</= 40 kg)
Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Control
n=16 Participants
Placebo: 250 mL of 5% dextrose infused IV over 2 hours
|
|---|---|---|---|
|
Number of Participants With Clinical Improvement at Day 14
|
9 Participants
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to day 28Number of patients who expired after treatment
Outcome measures
| Measure |
High Dose Intervention
n=15 Participants
600 mg of canakinumab (8 mg/kg for patients \</= 40 kg)
Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Low Dose Intervention
n=14 Participants
300 mg of canakinumab (4 mg/kg for patients \</= 40 kg)
Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Control
n=16 Participants
Placebo: 250 mL of 5% dextrose infused IV over 2 hours
|
|---|---|---|---|
|
All-cause Mortality
|
1 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
High Dose Intervention
Serious events: 5 serious events
Other events: 11 other events
Deaths: 1 deaths
Low Dose Intervention
Serious events: 6 serious events
Other events: 11 other events
Deaths: 3 deaths
Control
Serious events: 7 serious events
Other events: 11 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
High Dose Intervention
n=15 participants at risk
600 mg of canakinumab (8 mg/kg for patients \</= 40 kg)
Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Low Dose Intervention
n=14 participants at risk
300 mg of canakinumab (4 mg/kg for patients \</= 40 kg)
Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Control
n=16 participants at risk
Placebo
Placebos: 250 mL of 5% dextrose infused IV over 2 hours
|
|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.7%
1/15 • Number of events 1 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
12.5%
2/16 • Number of events 3 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
20.0%
3/15 • Number of events 3 • 150 days
|
35.7%
5/14 • Number of events 5 • 150 days
|
25.0%
4/16 • Number of events 4 • 150 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Cardiac disorders
Arrhythmia
|
13.3%
2/15 • Number of events 2 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/15 • 150 days
|
14.3%
2/14 • Number of events 2 • 150 days
|
0.00%
0/16 • 150 days
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 2 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
General disorders
Shock
|
6.7%
1/15 • Number of events 1 • 150 days
|
21.4%
3/14 • Number of events 4 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Infections and infestations
Superinfection
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Blood and lymphatic system disorders
Clot
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Skin and subcutaneous tissue disorders
Skin Breakdown
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Investigations
Decreased Platelet Count
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
12.5%
2/16 • Number of events 2 • 150 days
|
|
Infections and infestations
Fungemia
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/15 • 150 days
|
14.3%
2/14 • Number of events 2 • 150 days
|
0.00%
0/16 • 150 days
|
|
Cardiac disorders
Hypertensive
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Product Issues
Ventilator Tube Occlusion
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Blood and lymphatic system disorders
DVT
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
Other adverse events
| Measure |
High Dose Intervention
n=15 participants at risk
600 mg of canakinumab (8 mg/kg for patients \</= 40 kg)
Canakinumab Injection 600mg: Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Low Dose Intervention
n=14 participants at risk
300 mg of canakinumab (4 mg/kg for patients \</= 40 kg)
Canakinumab Injection 300mg: Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
|
Control
n=16 participants at risk
Placebo
Placebos: 250 mL of 5% dextrose infused IV over 2 hours
|
|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
26.7%
4/15 • Number of events 4 • 150 days
|
35.7%
5/14 • Number of events 5 • 150 days
|
37.5%
6/16 • Number of events 9 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
20.0%
3/15 • Number of events 4 • 150 days
|
14.3%
2/14 • Number of events 2 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Blood and lymphatic system disorders
Anemia
|
26.7%
4/15 • Number of events 4 • 150 days
|
0.00%
0/14 • 150 days
|
25.0%
4/16 • Number of events 7 • 150 days
|
|
Cardiac disorders
Arrhythmia
|
13.3%
2/15 • Number of events 2 • 150 days
|
14.3%
2/14 • Number of events 3 • 150 days
|
12.5%
2/16 • Number of events 2 • 150 days
|
|
Blood and lymphatic system disorders
Bleeding
|
6.7%
1/15 • Number of events 2 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Infections and infestations
Encephalitis/Meningitis
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.00%
0/15 • 150 days
|
28.6%
4/14 • Number of events 4 • 150 days
|
31.2%
5/16 • Number of events 5 • 150 days
|
|
Reproductive system and breast disorders
Pneumonia
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
12.5%
2/16 • Number of events 2 • 150 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
General disorders
Shock
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Investigations
Hypophosphatemia
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Blood and lymphatic system disorders
Clot
|
6.7%
1/15 • Number of events 1 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Investigations
Elevated Ferritin
|
13.3%
2/15 • Number of events 2 • 150 days
|
35.7%
5/14 • Number of events 5 • 150 days
|
31.2%
5/16 • Number of events 5 • 150 days
|
|
Cardiac disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • 150 days
|
14.3%
2/14 • Number of events 2 • 150 days
|
25.0%
4/16 • Number of events 4 • 150 days
|
|
Investigations
Elevated CRP
|
13.3%
2/15 • Number of events 2 • 150 days
|
42.9%
6/14 • Number of events 6 • 150 days
|
18.8%
3/16 • Number of events 3 • 150 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
General disorders
Lethargy
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
2/15 • Number of events 2 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
General disorders
Hypovolemia
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Endocrine disorders
Hypoglycemia
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Musculoskeletal and connective tissue disorders
Rigors
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
General disorders
Restless Leg Syndrome
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Nervous system disorders
Neuropathic Lower Extremity Pain
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Investigations
Hypernatremia
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Nervous system disorders
Encephalopathy
|
6.7%
1/15 • Number of events 1 • 150 days
|
14.3%
2/14 • Number of events 2 • 150 days
|
0.00%
0/16 • 150 days
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Renal and urinary disorders
UTI
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Nervous system disorders
Delirium
|
13.3%
2/15 • Number of events 2 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
18.8%
3/16 • Number of events 3 • 150 days
|
|
Infections and infestations
Positive Respiratory Culture
|
13.3%
2/15 • Number of events 2 • 150 days
|
0.00%
0/14 • 150 days
|
12.5%
2/16 • Number of events 4 • 150 days
|
|
Skin and subcutaneous tissue disorders
Skin Breakdown
|
0.00%
0/15 • 150 days
|
14.3%
2/14 • Number of events 2 • 150 days
|
12.5%
2/16 • Number of events 2 • 150 days
|
|
Investigations
Worsening D-Dimer
|
13.3%
2/15 • Number of events 2 • 150 days
|
35.7%
5/14 • Number of events 5 • 150 days
|
18.8%
3/16 • Number of events 3 • 150 days
|
|
General disorders
Fever
|
13.3%
2/15 • Number of events 2 • 150 days
|
21.4%
3/14 • Number of events 3 • 150 days
|
25.0%
4/16 • Number of events 4 • 150 days
|
|
Eye disorders
Corneal Abrasion
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Skin and subcutaneous tissue disorders
Wound
|
6.7%
1/15 • Number of events 1 • 150 days
|
0.00%
0/14 • 150 days
|
0.00%
0/16 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Infections and infestations
COVID 19 Hyperinflammation
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 2 • 150 days
|
18.8%
3/16 • Number of events 3 • 150 days
|
|
Infections and infestations
Elevated ANC
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
18.8%
3/16 • Number of events 3 • 150 days
|
|
Investigations
Elevated WBC
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
12.5%
2/16 • Number of events 2 • 150 days
|
|
Investigations
Elevated LD
|
0.00%
0/15 • 150 days
|
14.3%
2/14 • Number of events 2 • 150 days
|
18.8%
3/16 • Number of events 3 • 150 days
|
|
Investigations
Worsening of Hemoglobin and Hematocrit
|
6.7%
1/15 • Number of events 1 • 150 days
|
14.3%
2/14 • Number of events 3 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Cardiac disorders
Hypertension
|
13.3%
2/15 • Number of events 2 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Stidor
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Respiratory, thoracic and mediastinal disorders
Flash Pulmonary Edema
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
|
Nervous system disorders
Dysphagia
|
0.00%
0/15 • 150 days
|
21.4%
3/14 • Number of events 3 • 150 days
|
0.00%
0/16 • 150 days
|
|
Cardiac disorders
Elevated Cardiac Enzymes
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/15 • 150 days
|
0.00%
0/14 • 150 days
|
6.2%
1/16 • Number of events 1 • 150 days
|
|
General disorders
Hypothermia
|
0.00%
0/15 • 150 days
|
7.1%
1/14 • Number of events 1 • 150 days
|
0.00%
0/16 • 150 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place