Thrombosis and Covid-19

NCT04366778 | Completed

• 2 other identifiers: 69HCL20_0401 - COVBIOID-RCB
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 1

Brief Summary

The coronavirus disease of 2019 (COVID-19) is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), now deemed a pandemic by the World Health Organization. Some COVID-19 patients may develop coagulopathy which is associated with poor prognosis and high risk of thrombosis. Some patients develop severe thrombotic complications, such as pulmonary embolism, despite anti-thrombotic prophylaxis by low molecular weight heparin. The aim of this project is to evaluate modified thromboelastometry for identifying patients at high risk of thrombosis. The hypothesize is that hypofibrinolysis with increased plasma PAI-1, TAFI (thrombin-activatable fibrinolysis inhibitor ) levels in association with high thrombin generation may explain high incidence of thrombosis in this population. A simple laboratory assay, widely available in hospitals, such as thromboelastometry, might be of great clinical interest to detect Covid-19 patients with high risk of thrombosis. In order to make ROTEM more sensitive to hypofibrinolysis, exogenous t-PA will be added in the assay. The preliminary results showed that patients with Covid-19 have significant hypercoagulability detectable with ROTEM and Covid-19 patients with thrombosis have both hypercoagulability and hypofibrinolysis.

Conditions

Thrombosis; Covid-19; SARS-CoV 2

Outcome Measures

Primary Outcomes (7)

• Coagulability

  TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

  Day 0

• Coagulability

  TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

  Day 3

• Coagulability

  TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

  Day 6

• Coagulability

  TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

  Day 9

• Coagulability

  TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

  Day 12

• Coagulability

  TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min)

  Day 15

• Venous thrombotic event (VTE) or arterial thrombosis

  Occurence of VTE or arterial thrombosis during hospitalization : * Pulmonary embolism diagnosed with CT scan * Venous or arterial thrombosis diagnosed with ultrasound exam

  Day 15

Study Arms (2)

patients hospitalized for Covid-19

Patients with Covid-19 infection hospitalized in Lyon University Hospitals

Diagnostic Test: TEM-tPA

patients hospitalized for Covid-19 who present thrombosis

Patients with Covid-19 infection hospitalized in Lyon University Hospitals who present thrombosis during hospitalization

Diagnostic Test: TEM-tPA

Interventions

TEM-tPA DIAGNOSTIC_TEST

325 patients with Covid-19 hospitalized in Lyon University Hospitals will have TEM-tPA measurements in parallel to D-dimers every 3 days during the hospitalization period. TEM-tPA of patients with and without thrombosis will be compared and their fibrinolysis (PAI-1, TAFI, tPA, thrombin) will be further explored.

patients hospitalized for Covid-19; patients hospitalized for Covid-19 who present thrombosis

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

Patients with confirmed diagnosis of Covid-19 (PCR test positive or clinical signs associated with lung CR scan showing typical Covid-19 manifestation)

You may qualify if:

• Patients with Covid-19
• non-opposition of the patient to participate

You may not qualify if:

• Non-Covid-19 acute respiratory distress syndrome
• Non-Covid septicemia
• Pregnant women
• Breastfeeding women
• Protected vulnerable adults

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, 69500, France

Location

MeSH Terms

Conditions

Thrombosis; COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 29, 2020
• Study Start: May 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)