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

• Conditions: Pulmonary Embolism
• Interventions: Diagnostic Test: Serology test for COVID-19

• Registration Number: NCT04465656
• Lead Sponsor: 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 \[PCR-COVID 19-Pos\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-30
• Study Start: 2020-07-07
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06
• Primary Completion: 2020-10-31
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
[PCR-COVID 19-Neg] group	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

Primary Outcome Measures

Name	Time	Method
% 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.	6 months after PE diagnosis	PE complications : * Chronic interstitial pathology, or; * Recurrence of PE, or; * Pulmonary hypertension, or; * Death.

Secondary Outcome Measures

Name	Time	Method
% 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	Category of treatments: * Heparin + AVK; * Heparin + DOAC; PE complication : * Chronic interstitial pathology, or; * Recurrence of PE, or; * Pulmonary hypertension, or; * Death.
% 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	PE complications : * Chronic interstitial pathology, or; * Recurrence of PE, or; * Pulmonary hypertension, or; * Death.
% 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	PE complications : * Chronic interstitial pathology, or; * Recurrence of PE, or; * Pulmonary hypertension, or; * Death.
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	12 months after PE diagnosis	Category of treatments: * Heparin + AVK; * Heparin + DOAC
Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day)	12 months after PE diagnosis	Category of treatments: * Heparin + AVK; * Heparin + DOAC
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	Category of treatments: * Heparin + AVK; * Heparin + DOAC; Bleeding complications: classification 1-2-3-5 according to BARC

Trial Locations

Locations (1)

Hôpital Saint Joseph Marseille; 🇫🇷 Marseille, France