Multinational, Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Antithrombin Levels
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
- •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
研究组 & 干预措施
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.
干预措施: Antithrombin III (Drug)
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.
干预措施: Antithrombin III (Drug)
结局指标
主要结局
Antithrombin Levels
时间窗: throughout hospitalization, approximately 1-3 weeks
Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment
次要结局
- Hospital length of stay(throughout hospitalization, approximately 1-3 weeks)
- Mortality(throughout hospitalization, approximately 1-3 weeks)
- PT Levels(throughout hospitalization, approximately 1-3 weeks)
- aPPT Levels(throughout hospitalization, approximately 1-3 weeks)
- D-dimer Levels(throughout hospitalization, approximately 1-3 weeks)
- Haemoglobin Levels(throughout hospitalization, approximately 1-3 weeks)
- Fibrinogen Levels(throughout hospitalization, approximately 1-3 weeks)
- Platelet Levels(throughout hospitalization, approximately 1-3 weeks)
- Thromboembolic complications and bleeding events 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(throughout hospitalization, approximately 1-3 weeks)
- Number of days in ICU(throughout hospitalization, approximately 1-3 weeks)
- Quick Levels(throughout hospitalization, approximately 1-3 weeks)
- INR Levels(throughout hospitalization, approximately 1-3 weeks)
- Number of days requiring oxygenation(throughout hospitalization, approximately 1-3 weeks)
- Discharge disposition(throughout hospitalization, approximately 1-3 weeks)