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Antithrombin III in Infectious Disease Caused by COVID-19

Primary Purpose

Antithrombin III Deficiency, Covid19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antithrombin III
Sponsored by
Enrique Ginzburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antithrombin III Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

AT3 less than 100% with SOC plus AT3 supplement

AT3 less than 100% with SOC only

AT3 more than 100% with SOC only

Arm Description

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.

Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.

Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2021
Last Updated
August 16, 2022
Sponsor
Enrique Ginzburg
Collaborators
Grifols Biologicals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04899232
Brief Title
Antithrombin III in Infectious Disease Caused by COVID-19
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
There are fewer potential patients and an early conclusion of the study would be beneficial in an attempt to finish in a reasonable time and keep the cohorts homogenous.
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Enrique Ginzburg
Collaborators
Grifols Biologicals, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antithrombin III Deficiency, Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AT3 less than 100% with SOC plus AT3 supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
AT3 less than 100% with SOC only
Arm Type
No Intervention
Arm Description
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
Arm Title
AT3 more than 100% with SOC only
Arm Type
No Intervention
Arm Description
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
Intervention Type
Drug
Intervention Name(s)
Antithrombin III
Other Intervention Name(s)
Thrombate III
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in ISTH DIC Score
Description
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
Secondary Outcome Measure Information:
Title
Change in D-Dimer Levels
Description
D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)
Time Frame
Baseline, Day 9
Title
Change in Fibrinogen Levels
Description
Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.
Time Frame
Baseline, Day 9
Title
Change in Prothrombin Time
Description
Prothrombin time assessed from blood samples will be evaluated in seconds.
Time Frame
Baseline, Day 9
Title
Length of Hospital Stay
Description
Length of Hospital Stay reported in days.
Time Frame
Up to 60 days
Title
Mortality Rate
Description
The number of participants with reported death.
Time Frame
Up to 60 days
Title
Pulmonary Function
Description
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
Title
Change in SOFA Scores
Description
Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.
Time Frame
Baseline, Day9
Title
Change in SOFA Respiratory Sub Score
Description
SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure.
Time Frame
Baseline, Day 9
Title
Number of Events of Venous Thromboembolism
Description
Number of events of venous thromboembolisms from admission to hospital discharge.
Time Frame
Up to 60 days
Title
Number of Events of Major Bleeding
Description
Number of events of major bleeding from admission to hospital discharge.
Time Frame
Up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: >18y of age, Subject or proxy who can provide informed consent Positive SARS-COV-2 by Polymerase Chain Reaction (PCR) or as determined by clinical team EXCLUSION CRITERIA: Adults or Proxy unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners Patients expected to die within 24 hours or with a "do not resuscitate" order, Multi-organ failure, History of hypersensitivity or allergy to any component of the study drug, Ongoing massive surgical or unexplained bleeding, History of bleeding or clotting disorder, Severe traumatic brain injury (Glasgow Coma Scale <6), Spinal or multiple-trauma, Cancer (incurable/terminal phase) and/or patients receiving palliative care, Enrollment in another concurrent clinical interventional study if considered interfering with this study objectives Per study team discretion, any condition(s) that may prevent safe treatment, preclude adequate evaluation or adding further risk to their underlying illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Ginzburg
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Antithrombin III in Infectious Disease Caused by COVID-19

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