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

NCT04465656 | Completed

• 1 other identifier: 2020-05-01
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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 \[PCR-COVID 19-Pos\].

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• % 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 Outcomes (7)

• % 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.

  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).

  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

  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

  12 months after PE diagnosis

Study Arms (4)

[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

[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

Diagnostic Test: Serology test for COVID-19

[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

[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

Interventions

Serology test for COVID-19 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] group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)

You may qualify if:

• 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.

You may not qualify if:

• Subject to a measure for the protection of justice.

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hôpital Saint Joseph Marseille

Marseille, France

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Serologic Tests

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 10, 2020
• Study Start: July 7, 2020
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2022
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)