Not provided
Not provided
Not provided
Not provided
Not provided
There are fewer potential patients and an early conclusion of the study would be beneficial in an attempt to finish in a reasonable time and keep the cohorts homogenous.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Grifols Biologicals, LLC | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in D-Dimer Levels | D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU) | Baseline, Day 9 |
| Change in Fibrinogen Levels | Fibrinogen levels assessed from blood samples will be evaluated in mg/dL. |
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enrique Ginzburg | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39911044 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participant death while on the study is considered completion of study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| FG001 | AT3 Less Than 100% With SOC Only | Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only. |
| FG002 | AT3 More Than 100% With SOC Only | Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening Period |
|
| |||||||||||||||||||||
| Treatment Period |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Not all participants were able to complete the assessments required for evaluation of the DIC score. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 9 |
|
60 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AT3 Less Than 100% With SOC Plus AT3 Supplement | Participants in this group, with endogenous Antithrombin lll less than 100%, will receive up to 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment. Antithrombin III: A daily dose from 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight and current antithrombin II level, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enrique Ginzburg, MD | University of Miami | 305-585-1178 | eginzbur@med.miami.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2022 | Jun 2, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020152 | Antithrombin III Deficiency |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000990 | Antithrombin III |
| ID | Term |
|---|---|
| D058833 | Antithrombin Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, Day 9 |
| Change in Prothrombin Time | Prothrombin time assessed from blood samples will be evaluated in seconds. | Baseline, Day 9 |
| Length of Hospital Stay | Length of Hospital Stay reported in days. | Up to 60 days |
| Mortality Rate | The number of participants with reported death. | 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. | 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. | 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. | Baseline, Day 9 |
| Number of Events of Venous Thromboembolism | Number of events of venous thromboembolisms from admission to hospital discharge. | Up to 60 days |
| Number of Events of Major Bleeding | Number of events of major bleeding from admission to hospital discharge. | Up to 60 days |
| Participant discharged before receiving intervention |
|
| NOT COMPLETED |
|
| BG001 | AT3 Less Than 100% With SOC Only | Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only. |
| BG002 | AT3 More Than 100% With SOC Only | Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | AT3 Less Than 100% With SOC Only | Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only. |
| OG002 | AT3 More Than 100% With SOC Only | Participants in this group, with endogenous Antithrombin III more than 100%, will receive SOC treatment only. |
|
|
| Secondary | Change in D-Dimer Levels | D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU) | Not all participants were able to complete the assessments required for the evaluation of the D-dimer. | Posted | Mean | Standard Deviation | mcg/ml DDU | Baseline, Day 9 |
|
|
|
| Secondary | Change in Fibrinogen Levels | Fibrinogen levels assessed from blood samples will be evaluated in mg/dL. | Not all participants were able to complete the assessments required for evaluation of Fibrinogen levels. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 9 |
|
|
|
| Secondary | Change in Prothrombin Time | Prothrombin time assessed from blood samples will be evaluated in seconds. | Not all participants were able to complete the assessments required for evaluation of the Prothrombin Time levels. | Posted | Mean | Standard Deviation | Seconds | Baseline, Day 9 |
|
|
|
| Secondary | Length of Hospital Stay | Length of Hospital Stay reported in days. | Posted | Median | Standard Deviation | Days | Up to 60 days |
|
|
|
| Secondary | Mortality Rate | The number of participants with reported death. | Posted | Count of Participants | Participants | Up to 60 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Days | Up to 60 days |
|
|
|
| Secondary | Change in SOFA Scores | Sequential Organ Failure Assessment (SOFA) is scored from 0-4 with the higher score indicating more organ failure. | Not all participants were able to complete the assessments required for evaluation of the SOFA score. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day9 |
|
|
|
| Secondary | Change in SOFA Respiratory Sub Score | SOFA Respiratory Sub Score is scored from 0-4 with the higher score indicating worse organ failure. | Not all participants were able to complete the assessments required for evaluation of the SOFA sub score. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 9 |
|
|
|
| Secondary | Number of Events of Venous Thromboembolism | Number of events of venous thromboembolisms from admission to hospital discharge. | Posted | Number | Events | Up to 60 days |
|
|
|
| Secondary | Number of Events of Major Bleeding | Number of events of major bleeding from admission to hospital discharge. | Posted | Number | events | Up to 60 days |
|
|
|
| 2 |
| 15 |
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | AT3 Less Than 100% With SOC Only | Participants in this group, with endogenous Antithrombin III less than 100%, will receive SOC treatment only. | 3 | 20 | 0 | 20 | 5 | 20 |
| EG002 | AT3 of 100% or More, With SOC Only | Participants in this group, with endogenous Antithrombin III 100% or more, will receive SOC treatment only. | 3 | 12 | 0 | 12 | 8 | 12 |
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Shock | General disorders | Systematic Assessment |
|
| Heart Failure with reduced Ejection Fraction | Cardiac disorders | Systematic Assessment |
|
| Deep Vein Thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Ureterovesical Junction (UVJ) Calculus | Renal and urinary disorders | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Epistaxis | General disorders | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Worsening Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulseless Electrical Activity | Cardiac disorders | Systematic Assessment |
|
| Incidental Pulmonary Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Necrotic Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Critical Illness Polyneuropathy | Nervous system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Leukocytosis | Immune system disorders | Systematic Assessment |
|
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Asystole | Cardiac disorders | Systematic Assessment |
|
| Bilateral Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elevated D-Dimer | Blood and lymphatic system disorders | Systematic Assessment |
|
| Severe Acute Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Alkalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Right Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Subcutaneous Emphysema w/ Pneumomdiastinum | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dialysis | Renal and urinary disorders | Systematic Assessment |
|
| Thromocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Congestion | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| MSSA Bacteremia | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| D001796 | Blood Protein Disorders |
| D019851 | Thrombophilia |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000510 |
| Alpha-Globulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D005916 | Globulins |
| D019774 | Blood Coagulation Factor Inhibitors |
| D001685 | Biological Factors |