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

NCT04651400 | Completed

• 1 other identifier: ATN105
• Study Type: observational
• Target: 300
• Locations: 4 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Antithrombin Levels

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

  throughout hospitalization, approximately 1-3 weeks

Secondary Outcomes (15)

• aPPT Levels

  throughout hospitalization, approximately 1-3 weeks

• PT Levels

  throughout hospitalization, approximately 1-3 weeks

• Quick Levels

  throughout hospitalization, approximately 1-3 weeks

• INR Levels

  throughout hospitalization, approximately 1-3 weeks

• D-dimer Levels

  throughout hospitalization, approximately 1-3 weeks

Study Arms (4)

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.

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.

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.

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.

Interventions

Antithrombin III DRUG

Antithrombin III

COVID-19 patients who had received treatment with ATIII; Non-COVID-19 patients who had received treatment with ATIII

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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:
• 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)
• 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:
• For the +COVID-19 group:

Sponsors & Collaborators

• Octapharma: lead

Study Sites (6)

Octapharma Research Site

Innsbruck, 6020, Austria

Location

Octapharma Research Site

Vienna, 1090, Austria

Location

Octapharma Research Site

Strasbourg, France

Location

Octapharma Research Site

Aachen, 52074, Germany

Location

Octapharma Research Site

Essen, 45147, Germany

Location

ECMO Centre Karolinska

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

COVID-19

Interventions

Antithrombin III

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antithrombin Proteins; Serpins; Peptides; Amino Acids, Peptides, and Proteins; Alpha-Globulins; Serum Globulins; Blood Proteins; Proteins; Globulins; Blood Coagulation Factor Inhibitors; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 3, 2020
• Study Start: October 19, 2020
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

SE (1); FR (1); AU (2); DE (2)