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NCT Number: NCT04479540

Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With COVID-19 Lung Disease

The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.

The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE).

Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients.

To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.

The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.

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Key information

About this study

The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.

On April 3, 2020, in France, 59,105 confirmed cases have been identified. 6,305 people are hospitalized in intensive care and 4,503 patients died.

The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE). Very little data is available in the medical literature regarding PE during this infection.

Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients who are difficult to mobilize.

The diagnostic difficulties with traditional means, the seriousness and the ignorance of a PE make it necessary to evaluate the frequency of it in the patients having to be hospitalized by the practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.

The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.

The main objective of this work is therefore to determine the incidence of the occurrence of PE in patients with hospitalized SARS-CoV-2 pneumonitis by performing systematic thoracic angiography scanner in all hospitalized patients.

The secondary objective is to study the coagulation and fibrinolysis profile in these patients and to assess endothelial activation in order to better understand the physio-pathological mechanism behind PE and to determine if one of the parameters studied could be an indicator of PE risk.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • Any patient who consults in the emergency room, COVID+ with hospitalization criteria (dyspnea or desaturation ≤ 95% or chest pain or hemoptysis), including those who have already performed a CT angiogram upon arrival at the hospital.
  • Positive polymerase chain reaction (PCR) of coronavirus disease or compatible clinical signs associated with suggestive radiological criteria
  • Fever
  • Cough
  • Myalgia
  • Asthenia
  • Loss of taste/ Anosmia
  • signed informed consent before any study procedure
  • patients affiliated to an appropriate health insurance system

Exclusion criteria

  • Pregnancy in progress
  • Patient not having a microbiological diagnosis of SARS Coronavirus (COV-2) infection or whose symptoms are not suggestive
  • < 18 years
  • Be deprived of liberty or under guardianship
  • Patient with contra-indication to thoracic angiography scanner:
  • State of shock
  • Creatinine clearance < 30 mL/mn in Chronic Kidney Disease (CKD)
  • history of anaphylactic shock or angioedema with iodinated contrast media
  • uncontrolled cardiac decompensation
  • Patient with contra-indication to contrast media (Iomeron350®, Visipaque®):
  • History of immediate major or delayed skin reaction to the injection of a contrast medium
  • Hypersensitivity to the active substance or to any of the excipients
  • overt thyrotoxicosis

Patients with renal insufficiency and / or patients with allergy to iodinated contrast products may be included if they can perform a scintigraphy (the pulmonary scintigraphy being the alternative diagnostic to the CT angiography for renal insufficiency and / or allergy to iodinated contrast products).

Treatment and study plan

Angiography scanner

Radiation

systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)

Primary outcomes

  1. Rate of patients with pulmonary embolism

    Time frame: up to Day 12

    Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner

Secondary outcomes

  1. Prothrombin level measurement

    Time frame: up to Day 12

    Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  2. activated partial thromboplastin time measurement

    Time frame: up to Day 12

    Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  3. Fibrinogen measurement

    Time frame: up to Day 12

    Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  4. D-dimers measurement

    Time frame: up to Day 12

    Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  5. Protein C measurement

    Time frame: up to Day 12

    Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  6. Willebrand antigen measurement

    Time frame: up to Day 12

    Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  7. Soluble tissue factor measurement

    Time frame: up to Day 12

    Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  8. Soluble thrombomodulin measurement

    Time frame: up to Day 12

    Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  9. E-selectin measurement

    Time frame: up to Day 12

    Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  10. Thrombin-antithrombin complex measurement

    Time frame: up to Day 12

    Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization

  11. Assessment of clot formation curve

    Time frame: Day 1

    Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis

  12. Assessment of thrombin generation

    Time frame: Day 1

    Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis

  13. Assessment of fibrinolysis

    Time frame: Day 1

    Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis

  14. Mortality

    Time frame: Day 30

    Determine patient mortality

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Collaborators

  • Hospital Ambroise Paré Paris
  • University Hospital, Brest

Registry information

Official study title

Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease

Acronym: COVIDEP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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