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

NCT04377490 | Recruiting

• 1 other identifier: PI2020_843_0040
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Hemostasis; Coagulation

Keywords

COVID-19; venous ultrasound; Hemostasis; coagulation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Interventions

venous ultrasound OTHER

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

blood sample BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every patient hospitalized in CHU Amiens with COVID-19 infection

You may qualify if:

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

You may not qualify if:

• patients\< 18 years

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample for coagulation and hemostasis analysis

MeSH Terms

Conditions

COVID-19; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michel Slama, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Slama, Pr

CONTACT

(33)3 22 08 78 41; slama.michel@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 6, 2020
• Study Start: May 4, 2020
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)