Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 patients who had received treatment with ATIII 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
Antithrombin III
|
| COVID-19 patients who had not received treatment with ATIII 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 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
Antithrombin III
|
| Non-COVID-19 patients who had not received treatment with ATIII 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. |
Outcome Measures
Primary Outcome Measures
- Antithrombin Levels [throughout hospitalization, approximately 1-3 weeks]
Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment
Secondary Outcome Measures
- 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
- 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
- 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
- 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
Eligibility Criteria
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)
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Octapharma Research Site | Innsbruck | Austria | 6020 | |
| 2 | Octapharma Research Site | Wien | Austria | 1090 | |
| 3 | Octapharma Research Site | Strasbourg | France | ||
| 4 | Octapharma Research Site | Aachen | Germany | 52074 | |
| 5 | Octapharma Research Site | Essen | Germany | 45147 | |
| 6 | ECMO Centre Karolinska | Stockholm | Sweden | 17176 |
Sponsors and Collaborators
- Octapharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ATN105