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NCT Number: NCT04696913

Does COVID-19 Infection Increase the Risk of Pulmonary Embolism?

The World Health Organization (WHO) declared the 2019 novel coronavirus (COVID-19) a pandemic on March 11, 2020. As of 19 July 2020, there have been 14.3 million confirmed cases and over 600,000 confirmed deaths. Up to 14% of infected patients develop interstitial pneumonia, which may evolve to acute respiratory distress syndrome.

COVID-19 associated pulmonary arterial microthrombosis and coagulopathy has prompted physicians to implicate pulmonary embolism (PE) as a potential cause for acute respiratory deterioration.

Literature review reveals few studies of varying size, quality and design. Recent meta-analysis reports venous thromboembolism in approximately 20% of COVID-19 patients. There has yet to be a case-controlled study which proves and quantifies the associated between COVID-19 and PE.Confirming and quantifying this association has numerous clinical implications for the treatment of critically unwell patients with COVID-19 infection. For example, clinicians will be more inclined to investigate and treat sudden deteriorations with the knowledge that pulmonary embolism is the commonest cause for said deteriorations.

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Key information

Conditions

Covid19 COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Pulmonary Embolism RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

About this study

A retrospective case-control study of all patients who had a CT pulmonary angiogram (CTPA) at NHS Grampian between 3rd March and 20th June 2020 will be conducted.

CTPA reports and test results of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) for COVID-19 will be reviewed via electronic medical records.

Patients with no COVID-19 RT-PCR test done within 7 days of the CTPA or the same clinical episode will be excluded. Patients who had repeat CTPAs, who are already known to have a PE, and who had CTPAs which are considered to be radiologically inadequate will be excluded.

Patients will be categorised into cases (positive PE) and controls (negative PE).

CTPA images of cases will be reviewed to collect further data about severity, distribution and right heart strain.

Patients' exposure status will also be determined (positive or negative for COVID- 19 infection).

The primary outcome is the number of pulmonary embolism cases related to COVID19.

The secondary outcomes are the severity, distribution of pulmonary embolism as determined by calculated Qanadli score. Presence of right heart strain.

Further data for the multivariate analysis will be obtained from the patient's electronic medical record. Specifically, we will collect data on risk factors for COVID-19 infection and PE to correct for confounding.

Statistical data analysis by various hypothesis tests and multivariate logistic regression will be conducted to determine the odds ratio of developing a PE, given positive COVID-19 infection.

Patients with a positive PE will have their scans reviewed to quantitatively assess their clot burden and degree of right heart strain. The former will be done by calculating a Qanadil score. The latter will be done my measuring the right ventricle- left ventricle ratio. This will allow for a comparison between COVID-19 infected and non-infected patients with PE.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patients who had a CT pulmonary angiogram at NHS Grampian between 3rd March and 20th June 2020.

Exclusion criteria

  • Patients with no COVID-19 RT-PCR test done within 7 days of the CT pulmonary angiogram or the same clinical episode.
  • Duplicate CT pulmonary angiograms.
  • Patients who are already known to have a pulmonary embolism.
  • Patients who had radiologically inadequate CT pulmonary angiograms.
  • Patients younger than 16 years old.
  • Patients who have incomplete or unavailable notes.

Treatment and study plan

Exposure: Positive COVID-19 infection

Diagnostic Test

Exposure: Positive COVID-19 infection as determined by RT-PCR

Exposure: Negative COVID-19 infection

Diagnostic Test

Exposure: Negative COVID-19 infection as determined by RT-PCR

Primary outcomes

  1. Number of pulmonary embolism cases related to COVID-19.

    Time frame: 109 days

Secondary outcomes

  1. Severity, distribution of pulmonary embolism as determined by calculated Qanadli score.

    Time frame: 109 days

    Qanadli Score: The arterial tree of each lung is regarded as having 10 segmental PAs (three to the upper lobes,two to the middle lobe or lingula, and five to the lower lobes). The presence of an embolus in a segmental PA is scored as 1 point, and emboli at the most proximal arterial level are scored a value equal to the number of segmental PAs arising distally. To provide additional information on the residual perfusion distal to the embolus, a weighting factor is used for each value (0 for no defect, 1 for partial occlusion, and 2 for complete occlusion). An isolated subsegmental embolus is considered a partially occluded segmental PA and is assigned a value of 1. The maximum CT obstruction index is 40.

  2. Presence of right heart strain associated with pulmonary embolism.

    Time frame: 109 days

    As determined on CT by the presence of straightening of the interventricular septum and/or contrast reflux into the inferior vena cava and/or pulmonary artery measurements

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

Does COVID-19 Infection Increase the Risk of Pulmonary Embolism? A Retrospective Case-control Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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