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

Sponsor

Hopital Foch (Other)

Overall Status

Completed

CT.gov ID

NCT04479540

Collaborator

Hospital Ambroise Paré Paris (Other), University Hospital, Brest (Other)

117

Enrollment

Location

Arm

21.3

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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.

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 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 Design

Study Type:

Interventional

Actual Enrollment :

117 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 profileDetermination 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

Actual Primary Completion Date :

Feb 26, 2022

Actual Study Completion Date :

Mar 5, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Rate of patients with pulmonary embolism [up to Day 12]
Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).