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

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

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].

Study Overview

• Status: Unknown
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Diagnostic test: Serology test for COVID-19

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Cécile Bielmann; Phone Number: 0033 (0)4 88 73 10 70; Email: cbielmann@hopital-saint-joseph.fr
• Study Contact Backup: Name: Rahmia AHAMADA; Phone Number: 0033 (0)4 91 80 71 12; Email: rahamada@hopital-saint-joseph.fr

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Hôpital Saint Joseph Marseille
    • Contact: Roger Rosario, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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: ELISA test; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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
% 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
% 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	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
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
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
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

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Embolism and Thrombosis; COVID-19; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 2020-05-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No