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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT04899232
Status
Terminated
Sponsor
Enrique Ginzburg

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.