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Canakinumab in Covid-19 Cardiac Injury (The Three C Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04365153
Recruitment Status : Completed
First Posted : April 28, 2020
Results First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions COVID-19
SARS-CoV 2
Interventions Drug: Canakinumab Injection 600mg
Drug: Canakinumab Injection 300mg
Drug: Placebos
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Dose Intervention Low Dose Intervention Control
Hide Arm/Group Description

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

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

Placebo

Placebos: 250 mL of 5% dextrose infused IV over 2 hours

Period Title: Overall Study
Started 15 14 16
Completed 15 14 16
Not Completed 0 0 0
Arm/Group Title High Dose Intervention Low Dose Intervention Control Total
Hide Arm/Group Description

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

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

Placebo

Placebos: 250 mL of 5% dextrose infused IV over 2 hours

Total of all reporting groups
Overall Number of Baseline Participants 15 14 16 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 15 participants 14 participants 16 participants 45 participants
66.4
(63.5 to 72.9)
70.7
(64.7 to 74.6)
68.2
(56.1 to 83.3)
68.8
(61.1 to 74.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
Female
4
  26.7%
5
  35.7%
3
  18.8%
12
  26.7%
Male
11
  73.3%
9
  64.3%
13
  81.3%
33
  73.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
African-American
8
  53.3%
4
  28.6%
5
  31.3%
17
  37.8%
Caucasian
6
  40.0%
9
  64.3%
10
  62.5%
25
  55.6%
Asian
0
   0.0%
1
   7.1%
0
   0.0%
1
   2.2%
Hispanic
1
   6.7%
0
   0.0%
1
   6.3%
2
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 16 participants 45 participants
15 14 16 45
BMI  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 14 participants 16 participants 45 participants
29.2
(28.0 to 46.4)
28.3
(25.8 to 32.0)
29.2
(24.0 to 42.9)
28.8
(25.3 to 36.3)
Diabetes mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
10
  66.7%
4
  28.6%
7
  43.8%
21
  46.7%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
11
  73.3%
9
  64.3%
12
  75.0%
32
  71.1%
Hyperlipidemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
12
  80.0%
8
  57.1%
9
  56.3%
29
  64.4%
Coronary Artery Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
2
  13.3%
4
  28.6%
4
  25.0%
10
  22.2%
Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
0
   0.0%
1
   7.1%
1
   6.3%
2
   4.4%
Atrial fibrillation or flutter  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
2
  13.3%
2
  14.3%
2
  12.5%
6
  13.3%
COPD  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
3
  20.0%
3
  21.4%
2
  12.5%
8
  17.8%
Chronic kidney disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
6
  40.0%
2
  14.3%
7
  43.8%
15
  33.3%
Current or former smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
5
  33.3%
4
  28.6%
6
  37.5%
15
  33.3%
Time from symptoms onset to randomization  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 15 participants 14 participants 16 participants 45 participants
6
(3 to 8)
9
(6 to 11)
6
(4 to 10)
7
(4 to 9)
Dyspnea  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
11
  73.3%
11
  78.6%
14
  87.5%
36
  80.0%
Temperature  
Median (Inter-Quartile Range)
Unit of measure:  Degrees Celsius
Number Analyzed 15 participants 14 participants 16 participants 45 participants
36.8
(36.6 to 37.2)
37.4
(36.9 to 37.9)
36.8
(36.5 to 36.9)
36.9
(36.6 to 37.4)
Hospitalized requiring invasive mechanical ventilation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
5
  33.3%
2
  14.3%
3
  18.8%
10
  22.2%
Hospitalized requiring nasal high-flow oxygen or non-invasive ventilation, or both  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
3
  20.0%
3
  21.4%
5
  31.3%
11
  24.4%
Hospitalized requiring supplemental oxygen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
5
  33.3%
9
  64.3%
6
  37.5%
20
  44.4%
Hospitalized, not requiring supplemental oxygen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
2
  13.3%
0
   0.0%
2
  12.5%
4
   8.9%
Baseline PaO2/FiO2 ratio  
Median (Inter-Quartile Range)
Unit of measure:  Ratio
Number Analyzed 15 participants 14 participants 16 participants 45 participants
148
(73 to 203)
160
(77 to 246)
117
(66 to 210)
148
(73 to 204)
Baseline SOFA scores (SOFA: Sequential organ failure assessment)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Score on a scale
Number Analyzed 15 participants 14 participants 16 participants 45 participants
3
(2 to 6)
2
(2 to 4)
4
(2 to 5)
3
(2 to 5)
[1]
Measure Description: SOFA score is the Sequential Organ Failure Assessment which measures dysfunction within PaO2/FIO2 Factor, Platelets Factor, Total Bilirubin Factor, Blood Pressure, Glasgow Coma Score Factor and Renal Factor, each on a scale of 0 (normal function) to 4 (severe dysfunction). The total minimum score is 0, the total maximum score is 24, with higher scores indicating severe dysfunction.
Corticosteroids  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
8
  53.3%
3
  21.4%
10
  62.5%
21
  46.7%
Remdesivir  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 16 participants 45 participants
10
  66.7%
5
  35.7%
6
  37.5%
21
  46.7%
High sensitivity troponin T (ng/L) (reference range <12 ng/L)  
Median (Inter-Quartile Range)
Unit of measure:  ng/L
Number Analyzed 15 participants 14 participants 16 participants 45 participants
21
(15 to 31)
25
(14 to 36)
32
(16 to 163)
22
(15 to 37)
N-terminal pro B-type natriuretic peptide (pg/mL) (reference range <125 pg/mL)  
Median (Inter-Quartile Range)
Unit of measure:  pg/mL
Number Analyzed 15 participants 14 participants 16 participants 45 participants
371
(181 to 1401)
372
(277 to 1508)
810
(349 to 10264)
479
(248 to 1508)
C reactive protein (mg/dL) (reference range 0.0-0.4 mg/dL)  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 15 participants 14 participants 16 participants 45 participants
12.7
(10.8 to 19.7)
12.2
(6.4 to 15.3)
17.6
(15.0 to 19.9)
15.3
(12.1 to 18.5)
Lymphocyte count (reference range 1.0-4.0 k/uL)  
Median (Inter-Quartile Range)
Unit of measure:  k/uL
Number Analyzed 15 participants 14 participants 16 participants 45 participants
0.8
(0.7 to 1.0)
0.7
(0.5 to 1.2)
0.5
(0.4 to 0.9)
0.7
(0.5 to 1.0)
Ferritin (ng/mL)(reference range 14.7-205.1 ng/mL)  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 15 participants 14 participants 16 participants 45 participants
740
(448 to 1969)
998
(857 to 1626)
1246
(768 to 2355)
1015
(589 to 2111)
D-dimer (ng/mL)(reference range <500 ng/mL)  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 15 participants 14 participants 16 participants 45 participants
1795
(870 to 3430)
950
(730 to 1340)
1500
(560 to 3340)
1320
(730 to 2140)
1.Primary Outcome
Title Number of Participants With Clinical Improvement at Day 14
Hide Description Number of patients with either an improvement of two points on a seven category ordinal scale or discharge from the hospital
Time Frame Up to day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Intervention Low Dose Intervention Control
Hide Arm/Group Description:

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

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

Placebo: 250 mL of 5% dextrose infused IV over 2 hours
Overall Number of Participants Analyzed 15 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
9
  60.0%
7
  50.0%
9
  56.3%
2.Secondary Outcome
Title All-cause Mortality
Hide Description Number of patients who expired after treatment
Time Frame Up to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Intervention Low Dose Intervention Control
Hide Arm/Group Description:

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

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

Placebo

Placebos: 250 mL of 5% dextrose infused IV over 2 hours

Overall Number of Participants Analyzed 15 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
   6.7%
3
  21.4%
3
  18.8%
Time Frame 150 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Intervention Low Dose Intervention Control
Hide Arm/Group Description

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

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

Placebo

Placebos: 250 mL of 5% dextrose infused IV over 2 hours

All-Cause Mortality
High Dose Intervention Low Dose Intervention Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/15 (6.67%)      3/14 (21.43%)      4/16 (25.00%)    
Hide Serious Adverse Events
High Dose Intervention Low Dose Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/15 (33.33%)      6/14 (42.86%)      7/16 (43.75%)    
Blood and lymphatic system disorders       
Anemia   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Clot   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
DVT   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Cardiac disorders       
Arrhythmia   2/15 (13.33%)  2 1/14 (7.14%)  1 0/16 (0.00%)  0
Cardiac Arrest   0/15 (0.00%)  0 2/14 (14.29%)  2 0/16 (0.00%)  0
Hypertensive   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders       
Colitis   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
General disorders       
Shock   1/15 (6.67%)  1 3/14 (21.43%)  4 1/16 (6.25%)  1
Hepatobiliary disorders       
Liver Dysfunction   0/15 (0.00%)  0 1/14 (7.14%)  2 1/16 (6.25%)  1
Infections and infestations       
Superinfection   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Fungemia   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Investigations       
Decreased Platelet Count   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Nervous system disorders       
Encephalopathy   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Product Issues       
Ventilator Tube Occlusion   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Renal and urinary disorders       
Acute Kidney Injury   1/15 (6.67%)  1 1/14 (7.14%)  1 2/16 (12.50%)  3
Hematuria   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome   3/15 (20.00%)  3 5/14 (35.71%)  5 4/16 (25.00%)  4
Pneumonia   1/15 (6.67%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Chronic Respiratory Failure   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Hypoxia   0/15 (0.00%)  0 1/14 (7.14%)  1 2/16 (12.50%)  2
Pneumothorax   0/15 (0.00%)  0 2/14 (14.29%)  2 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin Breakdown   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose Intervention Low Dose Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/15 (73.33%)      11/14 (78.57%)      11/16 (68.75%)    
Blood and lymphatic system disorders       
Anemia   4/15 (26.67%)  4 0/14 (0.00%)  0 4/16 (25.00%)  7
Bleeding   1/15 (6.67%)  2 0/14 (0.00%)  0 1/16 (6.25%)  1
Clot   1/15 (6.67%)  1 1/14 (7.14%)  1 0/16 (0.00%)  0
Cardiac disorders       
Arrhythmia   2/15 (13.33%)  2 2/14 (14.29%)  3 2/16 (12.50%)  2
Hypotension   1/15 (6.67%)  1 2/14 (14.29%)  2 4/16 (25.00%)  4
Tachycardia   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Hypertension   2/15 (13.33%)  2 1/14 (7.14%)  1 0/16 (0.00%)  0
Elevated Cardiac Enzymes   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Congestive Heart Failure   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Endocrine disorders       
Hypoglycemia   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Eye disorders       
Corneal Abrasion   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Gastrointestinal disorders       
Diarrhea   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
General disorders       
Shock   1/15 (6.67%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Lethargy   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Hypovolemia   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Restless Leg Syndrome   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Fever   2/15 (13.33%)  2 3/14 (21.43%)  3 4/16 (25.00%)  4
Hypothermia   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Hepatobiliary disorders       
Liver Dysfunction   0/15 (0.00%)  0 4/14 (28.57%)  4 5/16 (31.25%)  5
Infections and infestations       
Encephalitis/Meningitis   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Positive Respiratory Culture   2/15 (13.33%)  2 0/14 (0.00%)  0 2/16 (12.50%)  4
COVID 19 Hyperinflammation   0/15 (0.00%)  0 1/14 (7.14%)  2 3/16 (18.75%)  3
Elevated ANC   0/15 (0.00%)  0 0/14 (0.00%)  0 3/16 (18.75%)  3
Investigations       
Hypophosphatemia   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Elevated Ferritin   2/15 (13.33%)  2 5/14 (35.71%)  5 5/16 (31.25%)  5
Elevated CRP   2/15 (13.33%)  2 6/14 (42.86%)  6 3/16 (18.75%)  3
Hypernatremia   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Worsening D-Dimer   2/15 (13.33%)  2 5/14 (35.71%)  5 3/16 (18.75%)  3
Elevated WBC   0/15 (0.00%)  0 0/14 (0.00%)  0 2/16 (12.50%)  2
Elevated LD   0/15 (0.00%)  0 2/14 (14.29%)  2 3/16 (18.75%)  3
Worsening of Hemoglobin and Hematocrit   1/15 (6.67%)  1 2/14 (14.29%)  3 1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders       
Musculoskeletal Pain   1/15 (6.67%)  1 0/14 (0.00%)  0 1/16 (6.25%)  1
Rigors   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Nervous system disorders       
Seizure   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Neuropathic Lower Extremity Pain   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Encephalopathy   1/15 (6.67%)  1 2/14 (14.29%)  2 0/16 (0.00%)  0
Delirium   2/15 (13.33%)  2 1/14 (7.14%)  1 3/16 (18.75%)  3
Dysphagia   0/15 (0.00%)  0 3/14 (21.43%)  3 0/16 (0.00%)  0
Renal and urinary disorders       
Acute Kidney Injury   4/15 (26.67%)  4 5/14 (35.71%)  5 6/16 (37.50%)  9
Hematuria   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Urinary Retention   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
UTI   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Reproductive system and breast disorders       
Pneumonia   1/15 (6.67%)  1 0/14 (0.00%)  0 2/16 (12.50%)  2
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome   3/15 (20.00%)  4 2/14 (14.29%)  2 1/16 (6.25%)  1
Aspiration   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Hypoxia   2/15 (13.33%)  2 0/14 (0.00%)  0 0/16 (0.00%)  0
Pneumomediastinum   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Pneumothorax   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Asthma Exacerbation   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Chronic Respiratory Failure   0/15 (0.00%)  0 0/14 (0.00%)  0 1/16 (6.25%)  1
Stidor   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Flash Pulmonary Edema   0/15 (0.00%)  0 1/14 (7.14%)  1 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin Breakdown   0/15 (0.00%)  0 2/14 (14.29%)  2 2/16 (12.50%)  2
Wound   1/15 (6.67%)  1 0/14 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Paul C. Cremer, MD
Organization: Cleveland Clinic
Phone: 216-444-6765
EMail: cremerp@ccf.org
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04365153    
Other Study ID Numbers: IND 149328
First Submitted: April 24, 2020
First Posted: April 28, 2020
Results First Submitted: April 5, 2021
Results First Posted: April 15, 2021
Last Update Posted: April 15, 2021