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

NCT ID: NCT04651400

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2022-09-27

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

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Antithrombin III

Intervention Type: DRUG

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.

No interventions assigned to this group

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.

Antithrombin III

Intervention Type: DRUG

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.

No interventions assigned to this group

Interventions

Antithrombin III

Antithrombin III

Intervention Type: DRUG

Eligibility Criteria

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)

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)

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

For Sites in France:

• 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:

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Octapharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Octapharma Research Site

Innsbruck, , Austria

Octapharma Research Site

Vienna, , Austria

Octapharma Research Site

Strasbourg, , France

Octapharma Research Site

Aachen, , Germany

Octapharma Research Site

Essen, , Germany

ECMO Centre Karolinska

Stockholm, , Sweden

Countries

Austria; France; Germany; Sweden

Other Identifiers

ATN105

Identifier Type: -

Identifier Source: org_study_id