Antithrombin III in Infectious Disease Caused by COVID-19

NCT04899232 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 20201048
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Antithrombin III Deficiency; Covid19

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 9

Secondary Outcomes (10)

• Change in D-Dimer Levels

  Baseline, Day 9

• Change in Fibrinogen Levels

  Baseline, Day 9

• Change in Prothrombin Time

  Baseline, Day 9

• Length of Hospital Stay

  Up to 60 days

• Mortality Rate

  Up to 60 days

Study Arms (3)

AT3 less than 100% with SOC plus AT3 supplement

EXPERIMENTAL

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

AT3 less than 100% with SOC only

NO INTERVENTION

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

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

Interventions

Antithrombin III DRUG

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).

Also known as: Thrombate III

AT3 less than 100% with SOC plus AT3 supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enrique Ginzburg: lead
• Grifols Biologicals, LLC: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Parker BM, Proctor KG, Guerra R, Manning RJ, Aguilar V, Meizoso JP, Pastewski A, Sneij W, Marttos AC, O'Neil CF, Ramsey WA, Namias N, Ginzburg E. A novel description of AT deficiency in hospitalized COVID-19 patients. Eur Rev Med Pharmacol Sci. 2025 Jan;29(1):30-38. doi: 10.26355/eurrev_202501_37057.

  PMID: 39911044 DERIVED

MeSH Terms

Conditions

Antithrombin III Deficiency; COVID-19

Interventions

Antithrombin III

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Protein Disorders; Thrombophilia; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antithrombin Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Alpha-Globulins; Serum Globulins; Blood Proteins; Proteins; Globulins; Blood Coagulation Factor Inhibitors; Biological Factors

Limitations and Caveats

With decreased Coronavirus disease of 2019 (COVID-19) cases, enrollment slowed leading to the early termination of the trial; the target number of 75 enrolled patients was not reached. Hesitancy to participate in the trial was noted.

Results Point of Contact

• Title: Enrique Ginzburg, MD
• Organization: University of Miami

eginzbur@med.miami.edu

305-585-1178

Study Officials

• Enrique Ginzburg

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 24, 2021
• Study Start: July 6, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: September 7, 2022
• Results First Posted: September 7, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)