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Thrombosis and Covid-19 (COVBIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366778
Recruitment Status : Completed
First Posted : April 29, 2020
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.

Condition or disease Intervention/treatment
Thrombosis Covid-19 SARS-CoV 2 Diagnostic Test: TEM-tPA

Study Design
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Study Type : Observational
Actual Enrollment : 341 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of Thrombosis
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : January 1, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
patients hospitalized for Covid-19
Patients with Covid-19 infection hospitalized in Lyon University Hospitals
 Diagnostic Test: TEM-tPA
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 who present thrombosis
Patients with Covid-19 infection hospitalized in Lyon University Hospitals who present thrombosis during hospitalization
 Diagnostic Test: TEM-tPA
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.


Outcome Measures
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Primary Outcome Measures :
  1. Coagulability [ Time Frame: Day 0 ]

    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)


  2. Coagulability [ Time Frame: Day 3 ]

    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)


  3. Coagulability [ Time Frame: Day 6 ]

    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)


  4. Coagulability [ Time Frame: Day 9 ]

    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)


  5. Coagulability [ Time Frame: Day 12 ]

    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)


  6. Coagulability [ Time Frame: Day 15 ]

    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)


  7. Venous thrombotic event (VTE) or arterial thrombosis [ Time Frame: Day 15 ]

    Occurence of VTE or arterial thrombosis during hospitalization :

    • Pulmonary embolism diagnosed with CT scan
    • Venous or arterial thrombosis diagnosed with ultrasound exam


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-Covid-19 acute respiratory distress syndrome
  • Non-Covid septicemia
  • Pregnant women
  • Breastfeeding women
  • Protected vulnerable adults
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): NCT04366778


Locations
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France
Hôpital Louis Pradel
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04366778    
Other Study ID Numbers: 69HCL20_0401 - COVBIO
ID-RCB ( Other Identifier: 2020-A01193-36 )
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
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
Additional relevant MeSH terms:
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COVID-19
Thrombosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases