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

ATN105

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

2020-10-19

2022-09-27

2022-09-27

Completed

300

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}

2023-10-10