Antithrombin III DeficiencyPhase 2NCT04899232
Antithrombin III in Infectious Disease Caused by COVID-19
A Phase 2 study testing Antithrombin III in people with Antithrombin III Deficiency and Covid19, run by Enrique Ginzburg at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antithrombin III Deficiency, Covid19
- What is being tested?
- Antithrombin III
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2021to 31 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antithrombin III (AT3) in Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)/ Coronavirus Disease of 2019 (COVID-19)
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
- Being tested
- Antithrombin III
- Medical subject headings
- Antithrombin III Deficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDrug
Also called Thrombate 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 9
Secondary outcomes (10)
Change in D-Dimer Levels
D-Dimer levels assessed from blood samples will be evaluated in mcg/ml D-Dimer Units (DDU)
Measured: Baseline, Day 9
Change in Fibrinogen Levels
Fibrinogen levels assessed from blood samples will be evaluated in mg/dL.
Measured: Baseline, Day 9
Change in Prothrombin Time
Prothrombin time assessed from blood samples will be evaluated in seconds.
Measured: Baseline, Day 9
Length of Hospital Stay
Length of Hospital Stay reported in days.
Measured: Up to 60 days
Mortality Rate
The number of participants with reported death.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Day 9
Number of Events of Venous Thromboembolism
Number of events of venous thromboembolisms from admission to hospital discharge.
Measured: Up to 60 days
Number of Events of Major Bleeding
Number of events of major bleeding from admission to hospital discharge.
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start6 Jul 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antithrombin III DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enrique Ginzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Sponsor-investigator, Enrique Ginzburg, University of Miami
- Investigators
- Enrique Ginzburg, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899232
- Sponsor's protocol ID
- 20201048
- Status last verified
- Aug 2022
- First submitted
- 20 May 2021
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39911044
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombin III (AT3) in Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)/ Coronavirus Disease of 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04899232
- Acronym / sponsor ID
- 20201048
- Conditions
- Antithrombin III Deficiency, Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Enrique GinzburgUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 7 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AT3 less than 100% with SOC plus AT3 supplement | Experimental | Drug: Antithrombin IIIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithrombin IIIAlso: Thrombate IIIFive 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). | Drug | AT3 less than 100% with SOC plus AT3 supplement |
Primary outcome
Change in ISTH DIC Score
Time frame: Baseline, Day 9
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.
10 secondary outcomes
Change in D-Dimer Levels
Time frame: Baseline, Day 9
Change in Fibrinogen Levels
Time frame: Baseline, Day 9
Change in Prothrombin Time
Time frame: Baseline, Day 9
Length of Hospital Stay
Time frame: Up to 60 days
Mortality Rate
Time frame: Up to 60 days
Pulmonary Function
Time frame: Up to 60 days
Change in SOFA Scores
Time frame: Baseline, Day9
Change in SOFA Respiratory Sub Score
Time frame: Baseline, Day 9
Number of Events of Venous Thromboembolism
Time frame: Up to 60 days
Number of Events of Major Bleeding
Time frame: Up to 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39911044Parker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Ginzburg principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antithrombin III in people with Antithrombin III Deficiency and Covid19, run by Enrique Ginzburg at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ISTH DIC Score (time frame: Baseline, Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04899232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.