Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy (THROMBCOVID2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04377490|
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 8, 2020
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components.
Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis.
Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19.
Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.
|Condition or disease||Intervention/treatment|
|COVID-19 Hemostasis Coagulation||Other: venous ultrasound Biological: blood sample|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy|
|Actual Study Start Date :||May 4, 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||November 2020|
- Other: venous ultrasound
Venous ultrasound will be performed on patients once a week, every week from the day of admission in Amiens Hospital until the day of patient discharge
- Biological: blood sample
blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in Amiens Hospital until the day of patient discharge
- Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients [ Time Frame: up to 6 weeks ]Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients. The reference range for the thrombin time is usually less than 20 seconds (ie, 15-19 seconds)
- Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients. [ Time Frame: up to 6 weeks ]Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.
- Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients [ Time Frame: up to 6 weeks ]Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients
- Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Hospitalized Covid-19 patients. [ Time Frame: up to 6 weeks ]Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Hospitalized Covid-19 patients.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377490
|Contact: Michel Slama, Pr||(33)3 22 08 78 firstname.lastname@example.org|
|Amiens, France, 80480|
|Contact: Michel Slama, Pr (33)3 22 08 78 41 email@example.com|
|Contact: Julien Maizel, Pr (33)3 22 08 78 07 firstname.lastname@example.org|
|Sub-Investigator: Yoann Zerbib, MD|
|Sub-Investigator: Simon Soudet, MD|
|Sub-Investigator: Valery Salle, MD|
|Sub-Investigator: Philippe Lanoix, Pr|
|Sub-Investigator: Claire Andrejak, Pr|
|Principal Investigator:||Michel Slama, Pr||CHU Amiens|