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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651400
• Other study ID #: ATN105
• Status: Completed
• Start date: October 19, 2020
• Est. completion date: September 27, 2022

Study information

• Verified date: October 2023
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Antithrombin III
Antithrombin III

Locations

Country	Name	City	State
Austria	Octapharma Research Site	Innsbruck
Austria	Octapharma Research Site	Wien
France	Octapharma Research Site	Strasbourg
Germany	Octapharma Research Site	Aachen
Germany	Octapharma Research Site	Essen
Sweden	ECMO Centre Karolinska	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Countries where clinical trial is conducted

Austria,  France,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antithrombin Levels	Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment	throughout hospitalization, approximately 1-3 weeks
Secondary	aPPT Levels	aPPT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	PT Levels	PT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	Quick Levels	Quick Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	INR Levels	INR Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	D-dimer Levels	D-dimer Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	Fibrinogen Levels	Fibrinogen Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	Haemoglobin Levels	Haemoglobin Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	Platelet Levels	Platelet Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group	throughout hospitalization, approximately 1-3 weeks
Secondary	Thromboembolic complications and bleeding events between groups	Comparison of the occurrence of thromboembolic complications and bleeding events between groups	throughout hospitalization, approximately 1-3 weeks
Secondary	Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO 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
Secondary	Hospital length of stay	Hospital length of stay between groups	throughout hospitalization, approximately 1-3 weeks
Secondary	Number of days in ICU	Number of days in ICU between groups	throughout hospitalization, approximately 1-3 weeks
Secondary	Number of days requiring oxygenation	Number of days requiring oxygenation between groups	throughout hospitalization, approximately 1-3 weeks
Secondary	Discharge disposition	Discharge disposition between groups	throughout hospitalization, approximately 1-3 weeks
Secondary	Mortality	Mortality between groups	throughout hospitalization, approximately 1-3 weeks