Antithrombin III in Infectious Disease Caused by COVID-19

Enrique Ginzburg

Status and phase: Terminated; Phase 2

Conditions: Antithrombin III Deficiency; Covid19

Treatments: Drug: Antithrombin III

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04899232

20201048

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 3 patient groups

AT3 less than 100% with SOC plus AT3 supplement

Experimental group

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.

Treatment:

Drug: Antithrombin III

AT3 less than 100% with SOC only

No Intervention group

Description:

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

AT3 more than 100% with SOC only

No Intervention group

Description:

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