The purpose of this research study is to see if participants who have SARS-CoV-2 and low levels of AT3 in the blood will benefit by being given AT3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
University of Miami
Miami, Florida, United States
Change in ISTH DIC Score
As measured by the International Society of Thrombosis and Haemostasis Disseminated Intravascular Coagulation scale (ISTH DIC) which has a total score ranging from 0-8 with a score of 5 and higher indicating overt DIC.
Time frame: Baseline, Day 9
Change in D-Dimer Levels
D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)
Time frame: Baseline, Day 9
Change in Fibrinogen Levels
Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.
Time frame: Baseline, Day 9
Change in Prothrombin Time
Prothrombin time assessed from blood samples will be evaluated in seconds.
Time frame: Baseline, Day 9
Length of Hospital Stay
Length of Hospital Stay reported in days.
Time frame: Up to 60 days
Mortality Rate
The number of participants with reported death.
Time frame: Up to 60 days
Pulmonary Function
Pulmonary Function will be reported as the mean days the participant was on any of the following: mechanical ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) use.
Time frame: Up to 60 days
Change in SOFA Scores
Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.
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Time frame: Baseline, Day9
Change in SOFA Respiratory Sub Score
SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure.
Time frame: Baseline, Day 9
Number of Events of Venous Thromboembolism
Number of events of venous thromboembolisms from admission to hospital discharge.
Time frame: Up to 60 days
Number of Events of Major Bleeding
Number of events of major bleeding from admission to hospital discharge.
Time frame: Up to 60 days