Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT04651400
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
Sex:
ALL
Study:
NCT04651400
Study Brief:
Protocol Section:
NCT04651400