Covid19
Conditions
Brief summary
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
Interventions
DRUGAntithrombin III
Antithrombin III
Sponsors
Octapharma
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antithrombin Levels | throughout hospitalization, approximately 1-3 weeks | Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PT Levels | throughout hospitalization, approximately 1-3 weeks | PT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| Quick Levels | throughout hospitalization, approximately 1-3 weeks | Quick Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| INR Levels | throughout hospitalization, approximately 1-3 weeks | INR Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| D-dimer Levels | throughout hospitalization, approximately 1-3 weeks | D-dimer Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| Fibrinogen Levels | throughout hospitalization, approximately 1-3 weeks | Fibrinogen Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| Haemoglobin Levels | throughout hospitalization, approximately 1-3 weeks | Haemoglobin Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| Platelet Levels | throughout hospitalization, approximately 1-3 weeks | Platelet Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| aPPT Levels | throughout hospitalization, approximately 1-3 weeks | aPPT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group |
| Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO 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 |
| Hospital length of stay | throughout hospitalization, approximately 1-3 weeks | Hospital length of stay between groups |
| Number of days in ICU | throughout hospitalization, approximately 1-3 weeks | Number of days in ICU between groups |
| Number of days requiring oxygenation | throughout hospitalization, approximately 1-3 weeks | Number of days requiring oxygenation between groups |
| Discharge disposition | throughout hospitalization, approximately 1-3 weeks | Discharge disposition between groups |
| Mortality | throughout hospitalization, approximately 1-3 weeks | Mortality between groups |
| Thromboembolic complications and bleeding events between groups | throughout hospitalization, approximately 1-3 weeks | Comparison of the occurrence of thromboembolic complications and bleeding events between groups |
Countries
Austria, France, Germany, Sweden
Outcome results
None listed