Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

COVID-19 Clinical Trial

— THROMBCOVID2  

Official title:

Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377490
• Other study ID #: PI2020_843_0040
• Status: Recruiting
• Start date: May 4, 2020
• Est. completion date: November 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Michel Slama, Pr
• Phone: (33)3 22 08 78 41
• Email: slama.michel[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients hospitalized in Amiens Hospital with COVID-19 infection

Exclusion Criteria:

• patients< 18 years

Related Conditions & MeSH terms

• Coagulation
• COVID-19
• Hemostasis
• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients	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)	up to 6 weeks
Primary	Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.	Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.	up to 6 weeks
Primary	Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients	Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients	up to 6 weeks
Primary	Variation of concentration of fibrin and fibrinogen degradation products (= 10 µgm/mL) in Hospitalized Covid-19 patients.	Variation of concentration of fibrin and fibrinogen degradation products (= 10 µgm/mL) in Hospitalized Covid-19 patients.	up to 6 weeks