Clinical trial NCT04651400: Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
Official title: Multinational, Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A target of 150 patients (male and female) hospitalised with severe COVID-19 infection and having required oxygen therapy (including those requiring a ventilator, central venous catheter or ECMO) will be included into this study. A control group of matched numbers of non-COVID-19 patients hospitalised and having required oxygen therapy will be included.

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


Eligibility 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

Primary outcomes:
measure: Antithrombin Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
Secondary outcomes:
measure: aPPT Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: PT Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Quick Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: INR Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: D-dimer Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Fibrinogen Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Haemoglobin Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Platelet Levels
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Thromboembolic complications and bleeding events between groups
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO between groups
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Hospital length of stay
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Number of days in ICU
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Number of days requiring oxygenation
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Discharge disposition
timeFrame: throughout hospitalization, approximately 1-3 weeks
measure: Mortality
timeFrame: throughout hospitalization, approximately 1-3 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Octapharma Research Site
city: Wien
country: Austria
facility: Octapharma Research Site
city: Strasbourg
country: France
facility: Octapharma Research Site
city: Aachen
country: Germany
facility: Octapharma Research Site
city: Essen
country: Germany
facility: Octapharma Research Site
city: Stockholm
country: Sweden
facility: ECMO Centre Karolinska
Study officials:
References: