Status:
TERMINATED
Antithrombin III in Infectious Disease Caused by COVID-19
Lead Sponsor:
Enrique Ginzburg
Collaborating Sponsors:
Grifols Biologicals, LLC
Conditions:
Antithrombin III Deficiency
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04899232
Start Date
July 6 2021
End Date
March 31 2022
Last Update
September 7 2022
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136