Antithrombin III in Infectious Disease Caused by COVID-19

Covid19 Clinical Trial

Official title:

Antithrombin III (AT3) in Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)/ Coronavirus Disease of 2019 (COVID-19)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04899232
• Other study ID #: 20201048
• Status: Terminated
• Phase: Phase 2
• Start date: July 6, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

1. >18y of age,

2. Subject or proxy who can provide informed consent

3. Positive SARS-COV-2 by Polymerase Chain Reaction (PCR) or as determined by clinical team

EXCLUSION CRITERIA:

1. Adults or Proxy unable to consent

2. Individuals who are not yet adults (infants, children, teenagers)

3. Pregnant women

4. Prisoners

5. Patients expected to die within 24 hours or with a "do not resuscitate" order,

6. Multi-organ failure,

7. History of hypersensitivity or allergy to any component of the study drug,

8. Ongoing massive surgical or unexplained bleeding,

9. History of bleeding or clotting disorder,

10. Severe traumatic brain injury (Glasgow Coma Scale <6),

11. Spinal or multiple-trauma,

12. Cancer (incurable/terminal phase) and/or patients receiving palliative care,

13. Enrollment in another concurrent clinical interventional study if considered interfering with this study objectives

14. Per study team discretion, any condition(s) that may prevent safe treatment, preclude adequate evaluation or adding further risk to their underlying illness.

Related Conditions & MeSH terms

• Antithrombin III Deficiency
• Communicable Diseases
• COVID-19
• Covid19
• Infections

Intervention

Drug:
• Antithrombin III
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).

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Enrique Ginzburg	Grifols Biologicals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 9
Secondary	Change in D-Dimer Levels	D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)	Baseline, Day 9
Secondary	Change in Fibrinogen Levels	Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.	Baseline, Day 9
Secondary	Change in Prothrombin Time	Prothrombin time assessed from blood samples will be evaluated in seconds.	Baseline, Day 9
Secondary	Length of Hospital Stay	Length of Hospital Stay reported in days.	Up to 60 days
Secondary	Mortality Rate	The number of participants with reported death.	Up to 60 days
Secondary	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.	Up to 60 days
Secondary	Change in SOFA Scores	Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.	Baseline, Day9
Secondary	Change in SOFA Respiratory Sub Score	SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure.	Baseline, Day 9
Secondary	Number of Events of Venous Thromboembolism	Number of events of venous thromboembolisms from admission to hospital discharge.	Up to 60 days
Secondary	Number of Events of Major Bleeding	Number of events of major bleeding from admission to hospital discharge.	Up to 60 days