A Phase 2 interventional study of Antithrombin III in Antithrombin III Deficiency and Covid19, sponsored by Enrique Ginzburg. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by Enrique Ginzburg · Phase 2, Interventional, and Treatment
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.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 52 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Enrique Ginzburg as lead sponsor.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
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
Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only.
Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only.
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
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.
Time frame: Baseline, Day 9
Change in D-Dimer Levels
D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)
Time frame: Baseline, Day 9
Change in Fibrinogen Levels
Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.
Time frame: Baseline, Day 9
Change in Prothrombin Time
Prothrombin time assessed from blood samples will be evaluated in seconds.
Time frame: Baseline, Day 9
Length of Hospital Stay
Length of Hospital Stay reported in days.
Time frame: Up to 60 days
Mortality Rate
The number of participants with reported death.
Time frame: Up to 60 days
Pulmonary Function
Pulmonary Function will be reported as the mean days the participant was on any of the following: mechanical ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) use.
Time frame: Up to 60 days
Change in SOFA Scores
Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.
Time frame: Baseline, Day9
Change in SOFA Respiratory Sub Score
SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure.
Time frame: Baseline, Day 9
Number of Events of Venous Thromboembolism
Number of events of venous thromboembolisms from admission to hospital discharge.
Time frame: Up to 60 days
Number of Events of Major Bleeding
Number of events of major bleeding from admission to hospital discharge.
Time frame: Up to 60 days
| Milestone | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Started | 20 | 20 | 12 |
| Completed | 15 | 20 | 12 |
| Not completed | 5 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Participant discharged before receiving intervention | 3 | 0 | 0 |
| Milestone | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Started | 15 | 20 | 12 |
| Completed | 15 | 20 | 12 |
| Not completed | 0 | 0 | 0 |
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.
| score on a scale | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Change in ISTH DIC Score | 0.27 ± 1.71 | 0 ± 1.73 | 0 ± 1.65 |
D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)
| mcg/ml DDU | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Change in D-Dimer Levels | -1.97 ± 5.60 | 0.4 ± 3.18 | 0.25 ± 2.18 |
Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.
| mg/dL | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Change in Fibrinogen Levels | -102.1 ± 233.7 | -123 ± 215.1 | -111 ± 307.5 |
Prothrombin time assessed from blood samples will be evaluated in seconds.
| Seconds | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Change in Prothrombin Time | 0.01 ± 2.07 | 0.31 ± 1.27 | 0.59 ± 1.39 |
Length of Hospital Stay reported in days.
| Days | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Length of Hospital Stay | 13 ± 15.1 | 6 ± 8.35 | 8.5 ± 9.46 |
The number of participants with reported death.
| Participants | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Mortality Rate | 2 | 3 | 3 |
Pulmonary Function will be reported as the mean days the participant was on any of the following: mechanical ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) use.
| Days | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Pulmonary Function | 1.33 ± 5.16 | 2.2 ± 6.70 | 3.08 ± 6.97 |
Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure.
| score on a scale | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Change in SOFA Scores | 0.43 ± 3.41 | 1.23 ± 3.33 | 0.64 ± 2.27 |
SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure.
| score on a scale | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Change in SOFA Respiratory Sub Score | -0.67 ± 0.98 | -0.07 ± 0.70 | -0.17 ± 1.69 |
Number of events of venous thromboembolisms from admission to hospital discharge.
| Events | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Number of Events of Venous Thromboembolism | 0 | 0 | 3 |
Number of events of major bleeding from admission to hospital discharge.
| events | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only |
|---|---|---|---|
| Number of Events of Major Bleeding | 0 | 0 | 2 |
Collected over 60 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AT3 Less Than 100% With SOC Plus AT3 Supplement | 2/15 (13.3%) | 0/15 (0%) | 5/15 (33.3%) |
| AT3 Less Than 100% With SOC Only | 3/20 (15%) | 0/20 (0%) | 5/20 (25%) |
| AT3 of 100% or More, With SOC Only | 3/12 (25%) | 0/12 (0%) | 8/12 (66.7%) |
| Event | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 of 100% or More, With SOC Only |
|---|---|---|---|
| Acute Kidney InjuryRenal and urinary disorders | 2/15 | 1/20 | 4/12 |
| Worsening Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/15 | 3/20 | 4/12 |
| ShockGeneral disorders | 1/15 | 2/20 | 2/12 |
| Atrial FibrillationCardiac disorders | 0/15 | 0/20 | 2/12 |
| AnemiaBlood and lymphatic system disorders | 1/15 | 1/20 | 2/12 |
| Pulseless Electrical ActivityCardiac disorders | 1/15 | 3/20 | 1/12 |
| Heart Failure with reduced Ejection FractionCardiac disorders | 0/15 | 0/20 | 1/12 |
| Deep Vein ThrombosisBlood and lymphatic system disorders | 0/15 | 0/20 | 1/12 |
| Ureterovesical Junction (UVJ) CalculusRenal and urinary disorders | 0/15 | 0/20 | 1/12 |
| Cardiac ArrestCardiac disorders | 0/15 | 0/20 | 1/12 |
| Age, Categorical(Participants) | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 14 | 9 | 38 |
| >=65 years | 5 | 6 | 3 | 14 |
| Sex: Female, Male(Participants) | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only | Total |
|---|---|---|---|---|
| Female | 6 | 7 | 4 | 17 |
| Male | 14 | 13 | 8 | 35 |
| Ethnicity (NIH/OMB)(Participants) | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 14 | 7 | 31 |
| Not Hispanic or Latino | 10 | 6 | 5 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AT3 Less Than 100% With SOC Plus AT3 Supplement | AT3 Less Than 100% With SOC Only | AT3 More Than 100% With SOC Only | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 5 | 4 | 17 |
| White | 12 | 14 | 8 | 34 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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