Covid19NCT04651400
Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
An observational study of Covid19, run by Octapharma at 6 sites in 4 countries.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Antithrombin III
- How many people
- 300 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 19 Oct 2020to 27 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
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- Patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO)
- 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)
- 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)
Who cannot join
- 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:
- 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)
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- Pregnant women
- For sites in Germany:
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Austria2 sites
Octapharma Research Site
Innsbruck, 6020
Octapharma Research Site
Vienna, 1090
Germany2 sites
Octapharma Research Site
Aachen, 52074
Octapharma Research Site
Essen, 45147
About this study
Official title: Multinational, 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
- Conditions
- Covid19
- Being tested
- Antithrombin III
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDrug
Antithrombin III
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antithrombin Levels
Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment
Measured: throughout hospitalization, approximately 1-3 weeks
Secondary outcomes (15)
aPPT Levels
aPPT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
PT Levels
PT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
Quick Levels
Quick Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
INR Levels
INR Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
D-dimer Levels
D-dimer Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
Fibrinogen Levels
Fibrinogen Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
Haemoglobin Levels
Haemoglobin Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
Platelet Levels
Platelet Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group
Measured: throughout hospitalization, approximately 1-3 weeks
Thromboembolic complications and bleeding events between groups
Comparison of the occurrence of thromboembolic complications and bleeding events between groups
Measured: throughout hospitalization, approximately 1-3 weeks
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
Measured: throughout hospitalization, approximately 1-3 weeks
Hospital length of stay
Hospital length of stay between groups
Measured: throughout hospitalization, approximately 1-3 weeks
Number of days in ICU
Number of days in ICU between groups
Measured: throughout hospitalization, approximately 1-3 weeks
Number of days requiring oxygenation
Number of days requiring oxygenation between groups
Measured: throughout hospitalization, approximately 1-3 weeks
Discharge disposition
Discharge disposition between groups
Measured: throughout hospitalization, approximately 1-3 weeks
Mortality
Mortality between groups
Measured: throughout hospitalization, approximately 1-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start19 Oct 2020
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651400
- Sponsor's protocol ID
- ATN105
- Status last verified
- Oct 2023
- First submitted
- 19 Nov 2020
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational, Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04651400
- Acronym / sponsor ID
- ATN105
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients who had received treatment with ATIII | – | Drug: Antithrombin IIIPatient 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. |
| 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 | – | Drug: Antithrombin IIIA 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. |
| 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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)
- 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)
Key exclusion criteria (11 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithrombin IIIAntithrombin III | Drug | COVID-19 patients who had received treatment with ATIII, Non-COVID-19 patients who had received treatment with ATIII |
Primary outcome
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
15 secondary outcomes
aPPT Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
PT Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
Quick Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
INR Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
D-dimer Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
Fibrinogen Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
Haemoglobin Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
Platelet Levels
Time frame: throughout hospitalization, approximately 1-3 weeks
Thromboembolic complications and bleeding events 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
Time frame: throughout hospitalization, approximately 1-3 weeks
Hospital length of stay
Time frame: throughout hospitalization, approximately 1-3 weeks
Number of days in ICU
Time frame: throughout hospitalization, approximately 1-3 weeks
Number of days requiring oxygenation
Time frame: throughout hospitalization, approximately 1-3 weeks
Discharge disposition
Time frame: throughout hospitalization, approximately 1-3 weeks
Mortality
Time frame: throughout hospitalization, approximately 1-3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Octapharma at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Germany, France, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antithrombin Levels (time frame: throughout hospitalization, approximately 1-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.