An observational study in Pulmonary Embolism, sponsored by Hospital St. Joseph, Marseille, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Hospital St. Joseph, Marseille, France · Observational
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].
Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)
Exclusion Criteria:
Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs
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
* 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
* 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
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)
% 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.
Time frame: 6 months after PE diagnosis
% 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after PE diagnosis
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital St. Joseph, Marseille, France