Incidence of Acute Pulmonary Embolism in Covid-19 Patients on CT Angiography and Relationship to D-dimer Levels (COVID-APE)

January 8, 2021 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Radiologie B - NHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with positive SARS-Cov-2 RT-PCR

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of positivity for Acute Pulmonary Embolism
Time Frame: March 1, 2020 - March 31, 2020
March 1, 2020 - March 31, 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7840

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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