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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373486
Other study ID # 7840
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2020
Est. completion date May 1, 2020

Study information

Verified date April 2020
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Reports of acute pulmonary embolism (APE) associated with COVID-19 have emerged in the literature. For example, Chen et al. described 25 pulmonary CT angiograms examinations from 1008 COVID-19 patients; 10 were positive for pulmonary embolism mostly as segmental or sub-segmental APE. Case reports of APE in Covid-19 patients have been published. Cui et al. found an incidence of deep venous thrombosis in intensive care unit (ICU) patients with severe Covid-19 pneumonia near to 25% (20/81), however without any correlation with potential APE. Despite these initial reports, it is not clear whether APE is more frequent in Covid-19 patients or if the association is just random. In favor of the former, D-dimer levels have been reported as elevated in patients with Covid-19 by two studies, and it has been suggested an independent association between the severity of the disease and the level of D-dimer. Finally, Tang et al. showed that anticoagulant therapy is associated with a decreased mortality at Day-28 in severe Covid-19 patients, in favor of a possible associated coagulopathy. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date May 1, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Positive SARS-Cov-2 RT-PCR - Chest CT angiography available - Patient is aged 18yo or above Exclusion Criteria: - Expressed opposition to participate - Adults under guardianship

Study Design


Locations

Country Name City State
France Service de Radiologie B - NHC Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of positivity for Acute Pulmonary Embolism March 1, 2020 - March 31, 2020