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

Octapharma

Status: Completed

Conditions: Covid19

Treatments: Drug: Antithrombin III

Study type: Observational

Funder types: Industry

Identifiers

NCT04651400

ATN105

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 4 patient groups

COVID-19 patients who had received treatment with ATIII

Description:

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.

Treatment:

Drug: Antithrombin III

COVID-19 patients who had not received treatment with ATIII

Description:

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

Description:

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.

Treatment:

Drug: Antithrombin III

Non-COVID-19 patients who had not received treatment with ATIII

Description:

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.