Clinical trial NCT04377490: Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy
Official title: Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Hemostasis
Coagulation
Keywords: COVID-19
venous ultrasound
Hemostasis
coagulation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient hospitalized in CHU Amiens with COVID-19 infection

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients\< 18 years

Primary outcomes:
measure: Variation of thrombin time (in secondes) in Hospitalized Covid-19 patients
timeFrame: up to 6 weeks
measure: Variation of factor V concentration (U/dL) in Hospitalized Covid-19 patients.
timeFrame: up to 6 weeks
measure: Variation of factor II concentration (U/dL) in Hospitalized Covid-19 patients
timeFrame: up to 6 weeks
measure: Variation of concentration of fibrin and fibrinogen degradation products (≥ 10 µgm/mL) in Hospitalized Covid-19 patients.
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Michel Slama, Pr
role: PRINCIPAL_INVESTIGATOR
References: