Clinical trial NCT04479540: Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With COVID-19 Lung Disease
Official title: Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Viral
Keywords: SARS COV-2
pulmonary embolism
acute respiratory distress syndrome
coagulation disorders
venous thromboembolic disease
Lead sponsor: Hopital Foch
Sponsor class: OTHER
Collaborators: name: Hospital Ambroise Paré Paris
name: University Hospital, Brest
First posted: 2020-07-21
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Rate of patients with pulmonary embolism
timeFrame: up to Day 12
Secondary outcomes:
measure: Prothrombin level measurement
timeFrame: up to Day 12
measure: activated partial thromboplastin time measurement
timeFrame: up to Day 12
measure: Fibrinogen measurement
timeFrame: up to Day 12
measure: D-dimers measurement
timeFrame: up to Day 12
measure: Protein C measurement
timeFrame: up to Day 12
measure: Willebrand antigen measurement
timeFrame: up to Day 12
measure: Soluble tissue factor measurement
timeFrame: up to Day 12
measure: Soluble thrombomodulin measurement
timeFrame: up to Day 12
measure: E-selectin measurement
timeFrame: up to Day 12
measure: Thrombin-antithrombin complex measurement
timeFrame: up to Day 12
measure: Assessment of clot formation curve
timeFrame: Day 1
measure: Assessment of thrombin generation
timeFrame: Day 1
measure: Assessment of fibrinolysis
timeFrame: Day 1
measure: Mortality
timeFrame: Day 30
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Foch HOSPITAL
name: Colas TCHERAKIAN, MD
role: PRINCIPAL_INVESTIGATOR
References: