NCT04373486: COVID-APE

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

Completed Last updated 11 January 2021

What this trial tests

trial in Covid-19 With Positive RT-PCR in 160 participants. Completed in 1 May 2020.

Timeline

3 March 2020

Primary endpoint
30 April 2020

1 May 2020

Quick facts

Lead sponsor	University Hospital, Strasbourg, France
Status	Completed
Study type	OBSERVATIONAL
Enrollment	160
Start date	3 March 2020
Primary completion	30 April 2020
Estimated completion	1 May 2020
Sites	1 location across France

Conditions studied

• Covid-19 With Positive RT-PCR — all drugs for Covid-19 With Positive RT-PCR →

Sponsor

University Hospital, Strasbourg, France

Who can join

18 and older, any sex, with Covid-19 With Positive RT-PCR. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The hypercoagulable state in COVID-19: Incidence, pathophysiology, and management.
   Abou-Ismail MY, Diamond A, Kapoor S, Arafah Y, et al · · 2020 · cited 465× · PMID 32788101 · DOI 10.1016/j.thromres.2020.06.029
2. Venous thrombosis epidemiology, pathophysiology, and anticoagulant therapies and trials in severe acute respiratory syndrome coronavirus 2 infection.
   Obi AT, Barnes GD, Napolitano LM, Henke PK, et al · · 2021 · cited 30× · PMID 32916371 · DOI 10.1016/j.jvsv.2020.08.030