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

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ClinicalTrials.gov Identifier: NCT04479540
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborators:
Hospital Ambroise Paré Paris
University Hospital, Brest
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pneumonia, Viral Radiation: Angiography scanner Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Determination of incidence of occurrence of pulmonary embolism in hospitalized patients with SARS-CoV-2 pneumonitis, first by performing systematic thoracic angiography scanner in all hospitalized patients and then to explore hemostasis profile
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : May 26, 2021
Estimated Study Completion Date : August 31, 2021


Arm Intervention/treatment
Experimental: Hospitalized SARS Cov-2
Hospitalized patients diagnosed with SARS Cov-2 infection
Radiation: Angiography scanner
systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years
  • Hospitalization criteria (according to Therapeutic recommendations for the management of coronavirus disease, version of the High Council of Public Health on April, 15, 2020) :

    • Ambient air saturation less than 95%
    • Polypnea (respiration rate > 24/min at rest)
    • Blood pressure < 100 mmHg
    • Vigilance disorders
    • Sudden alteration of the general condition or alertness in the elderly
  • 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
    • Renal failure
    • 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®, Optiject350®):

    • 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

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): NCT04479540


Contacts
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Contact: Christine FOULON +33146253618 drci-promotion@hopital-foch.com
Contact: Isabelle BUFFET +33146253748 i.buffet@hopital-foch.com

Locations
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France
Hôpital Foch Recruiting
Suresnes, France, 92150
Contact: Colas Tcherakian, MD         
Principal Investigator: Colas Tcherakian, MD         
Sponsors and Collaborators
Hopital Foch
Hospital Ambroise Paré Paris
University Hospital, Brest
Investigators
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Principal Investigator: Colas TCHERAKIAN, MD Foch HOSPITAL
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT04479540    
Other Study ID Numbers: 2020_0058
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: June 2020
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
Keywords provided by Hopital Foch:
SARS COV-2
pulmonary embolism
acute respiratory distress syndrome
coagulation disorders
venous thromboembolic disease
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Pulmonary Embolism
Embolism
Respiratory Tract Diseases
Respiratory Tract Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Virus Diseases