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Completed

NCT Number: NCT04465656

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Joseph Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • ELISA test
  • Rapid Diagnostic tests (only if ELISA test is positive)

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.

    Time frame: 6 months after PE diagnosis

    PE complications :

    • Chronic interstitial pathology, or
    • Recurrence of PE, or
    • Pulmonary hypertension, or
    • Death.

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.

    Time frame: 12 months after PE diagnosis

    PE complications :

    • Chronic interstitial pathology, or
    • Recurrence of PE, or
    • Pulmonary hypertension, or
    • Death.

  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).

    Time frame: 3, 6 and 12 months after PE diagnosis

    PE complications :

    • Chronic interstitial pathology, or
    • Recurrence of PE, or
    • Pulmonary hypertension, or
    • Death.

  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

    Time frame: 12 months after PE diagnosis

    Category of treatments:

    • Heparin + AVK
    • Heparin + DOAC

    PE complication :

    • Chronic interstitial pathology, or
    • Recurrence of PE, or
    • Pulmonary hypertension, or
    • Death.

  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

    Time frame: 12 months after PE diagnosis

    Category of treatments:

    • Heparin + AVK
    • Heparin + DOAC

    Bleeding complications: classification 1-2-3-5 according to BARC

  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

    Time frame: 12 months after PE diagnosis

    Category of treatments:

    • Heparin + AVK
    • Heparin + DOAC

  7. Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day)

    Time frame: 12 months after PE diagnosis

    Category of treatments:

    • Heparin + AVK
    • Heparin + DOAC

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic: Retrospective and Prospective Multicentric Study.

Acronym: COVID-EP

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 10, 2020
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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