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Completed

NCT Number: NCT04651400

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Octapharma Research Site, Innsbruck, Austria

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antithrombin III

Drug

Antithrombin III

Primary outcomes

  1. Antithrombin Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment

Secondary outcomes

  1. aPPT Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    aPPT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  2. PT Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    PT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  3. Quick Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Quick Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  4. INR Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    INR Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  5. D-dimer Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    D-dimer Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  6. Fibrinogen Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Fibrinogen Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  7. Haemoglobin Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Haemoglobin Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  8. Platelet Levels

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Platelet Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group

  9. Thromboembolic complications and bleeding events between groups

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Comparison of the occurrence of thromboembolic complications and bleeding events between groups

  10. Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO between groups

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO between groups

  11. Hospital length of stay

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Hospital length of stay between groups

  12. Number of days in ICU

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Number of days in ICU between groups

  13. Number of days requiring oxygenation

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Number of days requiring oxygenation between groups

  14. Discharge disposition

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Discharge disposition between groups

  15. Mortality

    Time frame: throughout hospitalization, approximately 1-3 weeks

    Mortality between groups

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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