Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic

Study Overview
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Brief Summary
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The purpose of the study COVID-EP is to classify all the complications occurring after the diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020). The patients will be followed for 1 year in order to provide clinical and paraclinical data not yet published in the literature. In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The collected complications will then be compared between each of the 3 following groups: [PCR-COVID 19-Neg & Sero-COVID 19-Neg] versus [PCR-COVID 19-Neg & Sero-COVID 19-Pos] versus [PCR-COVID 19-Pos].

Official Title
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Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic: Retrospective and Prospective Multicentric Study.

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Diagnostic Test: Serology test for COVID-19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 18 years, Diagnosed for pulmonary embolism between April 1st and April 30th, 2020; (treated by ambulatory care or hospitalized), Having given free and informed written consent, Being affiliated with or benefiting from a social security scheme. Exclusion Criteria: Subject to a measure for the protection of justice.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| [PCR-COVID 19-Pos] group<br>Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs | |
| [PCR-COVID 19-Neg] group<br>Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs | Diagnostic Test: Serology test for COVID-19<br>* In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed in two parts: ELISA test Rapid Diagnostic tests (only if ELISA test is positive)<br>|
| [PCR-COVID 19-Neg & Sero-COVID 19-Pos] group<br>Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs Having been tested positive in a serological test for COVID-19 at M3 | |
| [PCR-COVID 19-Neg & Sero-COVID 19-Neg] group<br>Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs Having been tested negative in a serological test for COVID-19 at M3 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients for each group presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 6 months after PE diagnosis. | PE complications : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death. | 6 months after PE diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients for each group and subgroup presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 12 months after PE diagnosis. | PE complications : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death. | 12 months after PE diagnosis | 
| % of patients in each group presenting the occurrence of each of the following events at each follow-up (3 months, 6 months and 12 months after PE diagnosis). | PE complications : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death. | 3, 6 and 12 months after PE diagnosis | 
| % of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis |  | 3 months after PE diagnosis | 
| Effectiveness of the different category of treatments used in all patients and in the groups: % of occurrence of PE complications for each categories of treatments | Category of treatments: Heparin + AVK Heparin + DOAC PE complication : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death. | 12 months after PE diagnosis | 
| Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with occurrence of bleeding complications for each categories of treatments | Category of treatments: Heparin + AVK Heparin + DOAC Bleeding complications: classification 1-2-3-5 according to BARC | 12 months after PE diagnosis | 
| Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with no occurrence of complications for each categories of treatments | Category of treatments: Heparin + AVK Heparin + DOAC | 12 months after PE diagnosis | 
| Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day) | Category of treatments: Heparin + AVK Heparin + DOAC | 12 months after PE diagnosis |