Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection

Study Overview
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Brief Summary
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Multicentre, multinational, non-interventional, observational, retrospective, patient record study to evaluate changes in coagulation parameters in patients with severe COVID-19 infection receiving/not treatment with antithrombin (AT) III

Official Title
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Multinational, Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection

Conditions
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Covid19

Intervention / Treatment
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* Drug: Antithrombin III


Participation Criteria
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Eligibility Criteria
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For Sites in Austria: Inclusion Criteria: For the +COVID-19 group: Confirmed COVID-19 positive test result OR extremely high likelihood of COVID-19 infection (e.g., family member or other person co-habiting with subject with a documented infection; passenger from cruise ship with +COVID- 19) Hospitalisation for severe COVID-19 infection until 01.06.2020 COVID-19 patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO) For the control group: Hospitalisation for any disease other than COVID-19 infection until end 2019 (31.12.2019) Patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO) Exclusion Criteria: Known hypersensitivity or allergic reaction to ATIII Participation in any interventional trial during the time of individual observational period (date of hospitalisation to the date of removal of oxygen therapy or death, whichever occurred first) Pregnant women For Sites in France: Inclusion Criteria: For the +COVID-19 group: Confirmed COVID-19 positive test result OR extremely high likelihood of COVID-19 infection (e.g., family member or other person co-habiting with subject with a documented infection; passenger from cruise ship with +COVID-19) Hospitalisation for severe COVID-19 infection and discharged from the hospital or died before start of documentation. COVID-19 patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO) For the control group: Hospitalisation for any disease other than COVID-19 infection until end 2019 (31.12.2019) Patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO) Exclusion Criteria: Known hypersensitivity or allergic reaction to ATIII Participation in any interventional trial during the time of individual observational period (date of hospitalisation to the date of removal of oxygen therapy or death, whichever occurred first) Pregnant women For sites in Germany: Inclusion Criteria: For the +COVID-19 group: Confirmed COVID-19 positive test result OR extremely high likelihood of COVID-19 infection (e.g., family member or other person co-habiting with subject with a documented infection; passenger from cruise ship with +COVID-19) Hospitalisation for severe COVID-19 infection until 01.02.2021. COVID-19 patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO) For the control group: Hospitalisation for any disease other than COVID-19 infection until end 2019 (31.12.2019) Patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO) Exclusion Criteria: Known hypersensitivity or allergic reaction to ATIII Participation in any interventional trial during the time of individual observational period (date of hospitalisation to the date of removal of oxygen therapy or death, whichever occurred first) Pregnant women
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 patients who had received treatment with ATIII<br>Patient records of patients hospitalised for severe COVID-19 infection until 01.06.2020 that required oxygen therapy will be used to retrospectively gather baseline demographic data (age, gender, height, weight, ethnicity/race, blood group, rhesus factor) and comorbidities. Records will also be used to retrospectively gather information on routine coagulation and laboratory parameters measured as per local protocols (including where available: AT, aPTT, PT, Quick, INR, , fibrinogen, D-dimers, haemoglobin levels, and platelet count), and thromboembolic complications and bleeding events that occurred during the individual observational treatment period. Patients will be grouped into 2 cohorts; those that received treatment with ATIII and those that did not. ATIII was administered as per local guidelines at each institute. | Drug: Antithrombin III<br>* Antithrombin III<br>|
| COVID-19 patients who had not received treatment with ATIII<br>Patient records of patients hospitalised for severe COVID-19 infection until 01.06.2020 that required oxygen therapy will be used to retrospectively gather baseline demographic data (age, gender, height, weight, ethnicity/race, blood group, rhesus factor) and comorbidities. Records will also be used to retrospectively gather information on routine coagulation and laboratory parameters measured as per local protocols (including where available: AT, aPTT, PT, Quick, INR, , fibrinogen, D-dimers, haemoglobin levels, and platelet count), and thromboembolic complications and bleeding events that occurred during the individual observational treatment period. Patients will be grouped into 2 cohorts; those that received treatment with ATIII and those that did not. ATIII was administered as per local guidelines at each institute. | |
| Non-COVID-19 patients who had received treatment with ATIII<br>A control group will be used to gather comparative data in non-COVID-19 patients. Data will be gathered retrospectively from patient records for severely ill patients who received oxygen therapy for non-COVID-19 infection until end 2019 (31.12.2019). Control group will also be grouped into 2 cohorts for those having received/ having not received ATIII treatment. | Drug: Antithrombin III<br>* Antithrombin III<br>|
| Non-COVID-19 patients who had not received treatment with ATIII<br>A control group will be used to gather comparative data in non-COVID-19 patients. Data will be gathered retrospectively from patient records for severely ill patients who received oxygen therapy for non-COVID-19 infection until end 2019 (31.12.2019). Control group will also be grouped into 2 cohorts for those having received/ having not received ATIII treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antithrombin Levels | Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment | throughout hospitalization, approximately 1-3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aPPT Levels | aPPT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| PT Levels | PT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| Quick Levels | Quick Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| INR Levels | INR Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| D-dimer Levels | D-dimer Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| Fibrinogen Levels | Fibrinogen Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| Haemoglobin Levels | Haemoglobin Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| Platelet Levels | Platelet Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group | throughout hospitalization, approximately 1-3 weeks | 
| Thromboembolic complications and bleeding events between groups | Comparison of the occurrence of thromboembolic complications and bleeding events between groups | throughout hospitalization, approximately 1-3 weeks | 
| Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO between groups | Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO between groups | throughout hospitalization, approximately 1-3 weeks | 
| Hospital length of stay | Hospital length of stay between groups | throughout hospitalization, approximately 1-3 weeks | 
| Number of days in ICU | Number of days in ICU between groups | throughout hospitalization, approximately 1-3 weeks | 
| Number of days requiring oxygenation | Number of days requiring oxygenation between groups | throughout hospitalization, approximately 1-3 weeks | 
| Discharge disposition | Discharge disposition between groups | throughout hospitalization, approximately 1-3 weeks | 
| Mortality | Mortality between groups | throughout hospitalization, approximately 1-3 weeks |