NCT04696913

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2022

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

November 19, 2020

Last Update Submit

May 14, 2026

Conditions

Keywords

Case-Control StudiesRetrospective Study

Outcome Measures

Primary Outcomes (1)

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

    109 days

Secondary Outcomes (2)

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

    109 days

  • Presence of right heart strain associated with pulmonary embolism.

    109 days

Study Arms (2)

Pulmonary Embolism Positive

As determined by CT Pulmonary Angiogram

Diagnostic Test: Exposure: Positive COVID-19 infectionDiagnostic Test: Exposure: Negative COVID-19 infection

Pulmonary Embolism Negative

As determined by CT Pulmonary Angiogram

Diagnostic Test: Exposure: Positive COVID-19 infectionDiagnostic Test: Exposure: Negative COVID-19 infection

Interventions

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

Pulmonary Embolism NegativePulmonary Embolism Positive

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

Pulmonary Embolism NegativePulmonary Embolism Positive

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute hospital inpatients

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

MeSH Terms

Conditions

COVID-19Pulmonary Embolism

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

January 6, 2021

Study Start

January 1, 2021

Primary Completion

March 3, 2022

Study Completion

March 3, 2022

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations