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

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

Study Overview

• Status: Completed
• Conditions: Pneumonia, Viral
• Intervention / Treatment: Radiation: Angiography scanner

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with pulmonary embolism	Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner	up to Day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prothrombin level measurement	Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
activated partial thromboplastin time measurement	Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Fibrinogen measurement	Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
D-dimers measurement	Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Protein C measurement	Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Willebrand antigen measurement	Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Soluble tissue factor measurement	Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Soluble thrombomodulin measurement	Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
E-selectin measurement	Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Thrombin-antithrombin complex measurement	Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Assessment of clot formation curve	Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis	Day 1
Assessment of thrombin generation	Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis	Day 1
Assessment of fibrinolysis	Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis	Day 1
Mortality	Determine patient mortality	Day 30

Collaborators and Investigators

• Sponsor: Hopital Foch
• Collaborators: University Hospital, Brest; Hospital Ambroise Paré Paris
• Investigators: Principal Investigator: Colas TCHERAKIAN, MD, Foch Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Actual): February 26, 2022
• Study Completion (Actual): March 5, 2022

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pulmonary embolism; acute respiratory distress syndrome; venous thromboembolic disease; SARS COV-2; coagulation disorders
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Embolism and Thrombosis; Lung Diseases; Embolism; Pneumonia, Viral; Pulmonary Embolism
• Other Study ID Numbers: 2020_0058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No