Covid19 Clinical Trial
Official title:
Multinational, Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
NCT number | NCT04651400 |
Other study ID # | ATN105 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 19, 2020 |
Est. completion date | September 27, 2022 |
Verified date | October 2023 |
Source | Octapharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 300 |
Est. completion date | September 27, 2022 |
Est. primary completion date | September 27, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Octapharma Research Site | Innsbruck | |
Austria | Octapharma Research Site | Wien | |
France | Octapharma Research Site | Strasbourg | |
Germany | Octapharma Research Site | Aachen | |
Germany | Octapharma Research Site | Essen | |
Sweden | ECMO Centre Karolinska | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Octapharma |
Austria, France, Germany, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antithrombin Levels | Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment | throughout hospitalization, approximately 1-3 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Hospital length of stay | Hospital length of stay between groups | throughout hospitalization, approximately 1-3 weeks | |
Secondary | Number of days in ICU | Number of days in ICU between groups | throughout hospitalization, approximately 1-3 weeks | |
Secondary | Number of days requiring oxygenation | Number of days requiring oxygenation between groups | throughout hospitalization, approximately 1-3 weeks | |
Secondary | Discharge disposition | Discharge disposition between groups | throughout hospitalization, approximately 1-3 weeks | |
Secondary | Mortality | Mortality between groups | throughout hospitalization, approximately 1-3 weeks |
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