Antithrombin III in Infectious Disease Caused by COVID-19
- Registration Number
- NCT04899232
- Lead Sponsor
- Enrique Ginzburg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AT3 less than 100% with SOC plus AT3 supplement Antithrombin III Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
- Primary Outcome Measures
Name Time Method Change in ISTH DIC Score Baseline, Day 9 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.
- Secondary Outcome Measures
Name Time Method Change in Fibrinogen Levels Baseline, Day 9 Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.
Mortality Rate Up to 60 days The number of participants with reported death.
Pulmonary Function Up to 60 days 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.
Change in SOFA Respiratory Sub Score Baseline, Day 9 SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure.
Change in SOFA Scores Baseline, Day9 Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.
Number of Events of Venous Thromboembolism Up to 60 days Number of events of venous thromboembolisms from admission to hospital discharge.
Length of Hospital Stay Up to 60 days Length of Hospital Stay reported in days.
Number of Events of Major Bleeding Up to 60 days Number of events of major bleeding from admission to hospital discharge.
Change in D-Dimer Levels Baseline, Day 9 D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)
Change in Prothrombin Time Baseline, Day 9 Prothrombin time assessed from blood samples will be evaluated in seconds.
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States