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Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy (THROMBCOVID2)

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ClinicalTrials.gov Identifier: NCT04377490
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Study Description
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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.


Condition or disease Intervention/treatment
COVID-19 Hemostasis Coagulation Other: venous ultrasound Biological: blood sample

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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.

  3. 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

  4. 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
blood sample for coagulation and hemostasis analysis

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patient hospitalized in CHU Amiens with COVID-19 infection
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients< 18 years
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Michel Slama, Pr (33)3 22 08 78 41 slama.michel@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Michel Slama, Pr    (33)3 22 08 78 41    slama.michel@chu-amiens.fr   
Contact: Julien Maizel, Pr    (33)3 22 08 78 07    maizel.julien@chu-amiens.fr   
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Michel Slama, Pr CHU Amiens
More Information
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04377490    
Other Study ID Numbers: PI2020_843_0040
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
COVID-19
venous ultrasound
Hemostasis
coagulation
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases