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Thrombosis and Covid-19 (COVBIO)

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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

Tracking Information
First Submitted Date April 23, 2020
First Posted Date April 29, 2020
Last Update Posted Date January 25, 2021
Actual Study Start Date May 1, 2020
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2020)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Thrombosis and Covid-19
Official Title Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of Thrombosis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition
  • Thrombosis
  • Covid-19
  • SARS-CoV 2
Intervention 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.
Study Groups/Cohorts
  • patients hospitalized for Covid-19
    Patients with Covid-19 infection hospitalized in Lyon University Hospitals
    Intervention: 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
    Intervention: Diagnostic Test: TEM-tPA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 22, 2021)
341
Original Estimated Enrollment
 (submitted: April 27, 2020)
300
Actual Study Completion Date January 1, 2021
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04366778
Other Study ID Numbers 69HCL20_0401 - COVBIO
ID-RCB ( Other Identifier: 2020-A01193-36 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date January 2021