Antithrombin III in Infectious Disease Caused by COVID-19

• Sponsor: Enrique Ginzburg (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04899232
• Collaborator: Grifols Biologicals, LLC (Industry)
• Enrollment: 52
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Antithrombin III Deficiency; Covid19	Drug: Antithrombin III	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jul 6, 2021
• Actual Primary Completion Date: Mar 31, 2022
• Actual Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AT3 less than 100% with SOC plus AT3 supplement 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.	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).; Other Names: Thrombate III
No Intervention: AT3 less than 100% with SOC only Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
No Intervention: AT3 more than 100% with SOC only Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. Change in Fibrinogen Levels [Baseline, Day 9]

   Fibrinogen levels assessed from blood samples will be evaluated in mg/dL Fibrinogen Equivalent Units (FEU).

3. Change in Prothrombin time [Baseline, Day 9]

   Prothrombin time assessed from blood samples will be evaluated in seconds.

4. Length of Hospital Stay [Up to 30 days]

   Length of Hospital Stay reported in days.

5. Mortality Rate [Up to 30 days]

   Percentage of reported death.

6. Pulmonary Function [Up to 30 days]

   Pulmonary Function will be reported as the days the participant was on any of the following: mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) use.

7. Change in SOFA scores [Baseline, Day9]

   Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.

8. 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.

9. Number of Incidences of venous thromboembolism [Up to 30 days]

   Number of incidences of venous thromboembolisms from admission to hospital discharge.

10. Number of incidences of major bleeding [Up to 30 days]

    Number of incidences of major bleeding from admission to hospital discharge.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• Enrique Ginzburg
• Grifols Biologicals, LLC

Investigators

• Principal Investigator: Enrique Ginzburg, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enrique Ginzburg, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04899232
• Other Study ID Numbers: 20201048
• First Posted: May 24, 2021
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: COVID-19; Communicable Diseases; Infections; Antithrombin III Deficiency; Antithrombins; Antithrombin III

Study Results

No Results Posted as of Apr 12, 2022