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

Pulmonary Embolism Clinical Trial

— COVID-EP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465656
• Other study ID #: 2020-05-01
• Status: Recruiting
• Start date: July 7, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2020
• Source: Hospital St. Joseph, Marseille, France
• Contact: Cécile Bielmann
• Phone: 0033 (0)4 88 73 10 70
• Email: cbielmann[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 30, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Saint Joseph Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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.	6 months after PE diagnosis
Secondary	% 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.	12 months after PE diagnosis
Secondary	% 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.	3, 6 and 12 months after PE diagnosis
Secondary	% 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
Secondary	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.	12 months after PE diagnosis
Secondary	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	12 months after PE diagnosis
Secondary	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	12 months after PE diagnosis
Secondary	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	12 months after PE diagnosis