Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
- Registration Number
- NCT04651400
- Lead Sponsor
- Octapharma
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 patients who had received treatment with ATIII Antithrombin III 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 Antithrombin III 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Hospital length of stay throughout hospitalization, approximately 1-3 weeks Hospital length of stay between groups
Mortality throughout hospitalization, approximately 1-3 weeks Mortality between groups
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
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
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
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
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
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
Number of days in ICU throughout hospitalization, approximately 1-3 weeks Number of days in ICU between groups
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
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
Trial Locations
- Locations (2)
ECMO Centre Karolinska
🇸🇪Stockholm, Sweden
Octapharma Research Site
🇩🇪Essen, Germany