Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT04651400
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2020-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000990', 'term': 'Antithrombin III'}], 'ancestors': [{'id': 'D058833', 'term': 'Antithrombin Proteins'}, {'id': 'D015843', 'term': 'Serpins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000510', 'term': 'Alpha-Globulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D019774', 'term': 'Blood Coagulation Factor Inhibitors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antithrombin Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Levels of AT in severely ill COVID-19 positive patients receiving/not receiving ATIII treatment'}], 'secondaryOutcomes': [{'measure': 'aPPT Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'aPPT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'PT Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'PT Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'Quick Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Quick Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'INR Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'INR Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'D-dimer Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'D-dimer Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'Fibrinogen Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Fibrinogen Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'Haemoglobin Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Haemoglobin Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'Platelet Levels', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Platelet Levels in severely ill COVID-19 patients receiving/not receiving ATIII treatment and compared to control group'}, {'measure': 'Thromboembolic complications and bleeding events between groups', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Comparison of the occurrence of thromboembolic complications and bleeding events between groups'}, {'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', 'description': 'Comparison of the duration of requirement for oxygen therapy, and invasive ventilation support or ECMO between groups'}, {'measure': 'Hospital length of stay', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Hospital length of stay between groups'}, {'measure': 'Number of days in ICU', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Number of days in ICU between groups'}, {'measure': 'Number of days requiring oxygenation', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Number of days requiring oxygenation between groups'}, {'measure': 'Discharge disposition', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Discharge disposition between groups'}, {'measure': 'Mortality', 'timeFrame': 'throughout hospitalization, approximately 1-3 weeks', 'description': 'Mortality between groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'For Sites in Austria:\n\nInclusion Criteria:\n\nFor the +COVID-19 group:\n\n* 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)\n* Hospitalisation for severe COVID-19 infection until 01.06.2020\n* COVID-19 patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO)\n\nFor the control group:\n\n* Hospitalisation for any disease other than COVID-19 infection until end 2019 (31.12.2019)\n* Patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO)\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergic reaction to ATIII\n* 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)\n* Pregnant women\n\nFor Sites in France:\n\nInclusion Criteria:\n\nFor the +COVID-19 group:\n\n* 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)\n* 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)\n\nFor the control group:\n\n* Hospitalisation for any disease other than COVID-19 infection until end 2019 (31.12.2019)\n* Patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO)\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergic reaction to ATIII\n* 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)\n* Pregnant women\n\nFor sites in Germany:\n\nInclusion Criteria:\n\nFor the +COVID-19 group:\n\n* 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)\n* Hospitalisation for severe COVID-19 infection until 01.02.2021.\n* COVID-19 patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO)\n\nFor the control group:\n\n* Hospitalisation for any disease other than COVID-19 infection until end 2019 (31.12.2019)\n* Patients having required oxygen therapy as per local guidelines (including those requiring a ventilator, central venous catheter or ECMO)\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergic reaction to ATIII\n* 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)\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT04651400', 'briefTitle': 'Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Octapharma'}, 'officialTitle': 'Multinational, Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection', 'orgStudyIdInfo': {'id': 'ATN105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 patients who had received treatment with ATIII', 'description': '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.', 'interventionNames': ['Drug: Antithrombin III']}, {'label': 'COVID-19 patients who had not received treatment with ATIII', 'description': '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.'}, {'label': 'Non-COVID-19 patients who had received treatment with ATIII', 'description': 'A control group will be used to gather comparative data in non-COVID-19 patients.\n\nData 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.', 'interventionNames': ['Drug: Antithrombin III']}, {'label': 'Non-COVID-19 patients who had not received treatment with ATIII', 'description': 'A control group will be used to gather comparative data in non-COVID-19 patients.\n\nData 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': [{'name': 'Antithrombin III', 'type': 'DRUG', 'description': 'Antithrombin III', 'armGroupLabels': ['COVID-19 patients who had received treatment with ATIII', 'Non-COVID-19 patients who had received treatment with ATIII']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Octapharma Research Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Octapharma Research Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Octapharma Research Site', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Octapharma Research Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Octapharma Research Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'ECMO Centre Karolinska', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Octapharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}