Clinical trial NCT04465656: Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)

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 \[PCR-COVID 19-Pos\].


Eligibility 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.

Primary outcomes:
measure: % 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.
timeFrame: 6 months after PE diagnosis
Secondary outcomes:
measure: % 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.
timeFrame: 12 months after PE diagnosis
measure: % 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).
timeFrame: 3, 6 and 12 months after PE diagnosis
measure: % of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis
timeFrame: 3 months after PE diagnosis
measure: 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
timeFrame: 12 months after PE diagnosis
measure: 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
timeFrame: 12 months after PE diagnosis
measure: 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
timeFrame: 12 months after PE diagnosis
measure: Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day)
timeFrame: 12 months after PE diagnosis
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Saint Joseph Marseille
Study officials:
References: