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CompletedNCT04465656COVID-EPUpdated Jan 22, 2026

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

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

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
88
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 138 studies in Pulmonary Embolism with a site in France — 24 open to participants now, 27 under way, 4 of them phase 3. Pulmonary Embolism · France.

Enrollment
54th of 63
88 · median 302
Started
2020
with 13 others
Observational
63 of 138
7 open now
Registered
93rd of 138
by date

Among the 138 studies in Pulmonary Embolism with a site in France, this one is the 54th largest by enrollment of the 63 observational ones that give a count, is one of 14 that started in 2020, is one of 63 observational ones, and was the 93rd registered.

Pulmonary Embolism

832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.

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Open to participants now

24 of the 138 studies in Pulmonary Embolism with a site in France are open now. Recruiting first, the newest first:

19 more — sign in →

All 24 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 129 Pulmonary Embolism studies recruiting now, 109 (84%) set no upper age limit and 5 (4%) stop at 75 or younger; 9 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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].

03

Conditions studied

  • Pulmonary Embolism

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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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

Exclusion Criteria:

  • Subject to a measure for the protection of justice.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and cohorts

  • [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

  • Diagnostic testSerology 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)

06

What researchers measure

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.

    Time frame: 6 months after PE diagnosis

Secondary outcomes

  1. % 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

  2. % 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

  3. % 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

  4. 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

  5. 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

  6. 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

  7. 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

07

Study locations

1 site
  • Hôpital Saint Joseph Marseille
    Marseille, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2020 to primary completion in Sep 2021, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 30, 2020
First posted
Jul 10, 2020
StartActual
Jul 7, 2020
Primary completionActual
Sep 8, 2021
CompletionActual
Sep 8, 2022
Last update
Jan 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04465656
Lead sponsor
Hospital St. Joseph, Marseille, France
Responsible party
Sponsor
First posted
Jul 10, 2020
Start date
Jul 7, 2020
Primary completion
Sep 8, 2021
Completion
Sep 8, 2022
Last update
Jan 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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