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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2022-09-08

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 \[PCR-COVID 19-Pos\].

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Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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[PCR-COVID 19-Pos] group

Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs

No interventions assigned to this group

[PCR-COVID 19-Neg] group

Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs

Serology test for COVID-19

Intervention Type DIAGNOSTIC_TEST

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:

1. ELISA test
2. Rapid Diagnostic tests (only if ELISA test is positive)

[PCR-COVID 19-Neg & Sero-COVID 19-Pos] group

* 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

No interventions assigned to this group

[PCR-COVID 19-Neg & Sero-COVID 19-Neg] group

* 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

No interventions assigned to this group

Interventions

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Serology test for COVID-19

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:

1. ELISA test
2. Rapid Diagnostic tests (only if ELISA test is positive)

Intervention Type DIAGNOSTIC_TEST

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.