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

Hospital Saint Joseph

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Diagnostic Test: Serology test for COVID-19

Study type: Observational

Funder types: Other

Identifiers

NCT04465656

2020-05-01

Details and patient eligibility

About

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].

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

88 participants in 4 patient groups

[PCR-COVID 19-Pos] group

Description:

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

Description:

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

Treatment:

Diagnostic Test: Serology test for COVID-19

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

Description:

* 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

Description:

* 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