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

Pneumonia, Viral Clinical Trial

— COVIDEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479540
• Other study ID #: 2020_0058
• Status: Completed
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: March 5, 2022

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 5, 2022
• Est. primary completion date: February 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Embolism
• Lung Diseases
• Pneumonia, Viral
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (3)

Lead Sponsor	Collaborator
Hopital Foch	Hospital Ambroise Paré Paris, University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with pulmonary embolism	Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner	up to Day 12
Secondary	Prothrombin level measurement	Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Secondary	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
Secondary	Fibrinogen measurement	Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Secondary	D-dimers measurement	Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Secondary	Protein C measurement	Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Secondary	Willebrand antigen measurement	Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Secondary	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
Secondary	Soluble thrombomodulin measurement	Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Secondary	E-selectin measurement	Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization	up to Day 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Assessment of fibrinolysis	Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis	Day 1
Secondary	Mortality	Determine patient mortality	Day 30