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

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ClinicalTrials.gov Identifier: NCT04465656
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital St. Joseph, Marseille, France

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].

Condition or disease Intervention/treatment
Pulmonary Embolism Diagnostic Test: Serology test for COVID-19

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic: Retrospective and Prospective Multicentric Study.
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
[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

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 & 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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465656


Contacts
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Contact: Cécile Bielmann 0033 (0)4 88 73 10 70 cbielmann@hopital-saint-joseph.fr
Contact: Rahmia AHAMADA 0033 (0)4 91 80 71 12 rahamada@hopital-saint-joseph.fr

Locations
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France
Hôpital Saint Joseph Marseille Recruiting
Marseille, France
Contact: Roger Rosario, Dr         
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
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Responsible Party: Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT04465656    
Other Study ID Numbers: 2020-05-01
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases