NCT04824313

Brief Summary

Chest computed tomography of patients having coronavirus disease (COVID-19) will be analyzed with regards to vascular abnormalities (pulmonary embolism and vascular thickening), and their association with lung inflammation. The prevalence, severity, distribution, and prognostic value of chest CT findings will be assessed. Patients with vascular abnormalities will be compared to patients without, which is supposed to provide insights into the prognostic role of such abnormalities, and the potential impact on treatment strategy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

February 18, 2021

Last Update Submit

March 30, 2021

Conditions

Covid19Pneumonia, ViralPulmonary Embolism

Keywords

COVID-19Computed tomographyVascular abnormalitiesLung infectionThromboembolism

Outcome Measures

Primary Outcomes (4)

  • Incidence of acute pulmonary embolism

    Incidence of acute pulmonary embolism (PE).

    March 1st, 2020 to July 31st, 2020

  • Distribution of acute pulmonary embolism

    Description of the anatomical distribution (lobar and segmental level)

    March 1st, 2020 to July 31st, 2020

  • Pulmonary embolism clot burden

    Description of the clot burden of acute pulmonary embolism (PE) using the CT obstruction index

    March 1st, 2020 to July 31st, 2020

  • Association of pulmonary embolism with ground glass opacity

    Rate of PE in segments with vs. without COVID-19 ground glass opacity

    March 1st, 2020 to July 31st, 2020

Secondary Outcomes (11)

  • Clinical outcome

    March 1st, 2020 to July 31st, 2020

  • D-dimers

    March 1st, 2020 to July 31st, 2020

  • PO2

    March 1st, 2020 to July 31st, 2020

  • SaO2

    March 1st, 2020 to July 31st, 2020

  • CRP

    March 1st, 2020 to July 31st, 2020

  • +6 more secondary outcomes

Study Arms (2)

COVID-CAVA PE

Patients with RT-PCR proven COVID-19 disease and CTA proven pulmonary embolism

Diagnostic Test: Chest CTA

COVID-CAVA non-PE

Patients with RT-PCR proven COVID-19 disease and no evidence of pulmonary embolism on CT

Diagnostic Test: Chest CTDiagnostic Test: Chest CTA

Interventions

Chest CTDIAGNOSTIC_TEST

Chest CT without intravenous contrast material

COVID-CAVA non-PE
Chest CTADIAGNOSTIC_TEST

Chest CT with intravenous contrast material

COVID-CAVA PECOVID-CAVA non-PE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with positive rt-PCR for SARS-CoV-2 and chest CT (with or without intravenous contrast material injection) within the specified time frame.

You may qualify if:

  • Patients admitted for COVID-19 (with positive rt-PCR for SARS-CoV-2) who had a contrast-enhanced chest CT within the specified timeframe.

You may not qualify if:

  • Age \<18 years Patients with another pre-existing infectious process Documented refusal of the reuse of medical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • Qanadli SD, Beigelman-Aubry C, Rotzinger DC. Vascular Changes Detected With Thoracic CT in Coronavirus Disease (COVID-19) Might Be Significant Determinants for Accurate Diagnosis and Optimal Patient Management. AJR Am J Roentgenol. 2020 Jul;215(1):W15. doi: 10.2214/AJR.20.23185. Epub 2020 Apr 7. No abstract available.

    PMID: 32255684BACKGROUND

  • Nevesny F, Rotzinger DC, Sauter AW, Loebelenz LI, Schmuelling L, Alkadhi H, Ebner L, Christe A, Platon A, Poletti PA, Qanadli SD. Acute Pulmonary Embolism in COVID-19: A Potential Connection between Venous Congestion and Thrombus Distribution. Biomedicines. 2022 Jun 2;10(6):1300. doi: 10.3390/biomedicines10061300.

    PMID: 35740322DERIVED

MeSH Terms

Conditions

COVID-19Pneumonia, ViralPulmonary EmbolismThromboembolism

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. MD, PhD

Study Record Dates

First Submitted

February 18, 2021

First Posted

April 1, 2021

Study Start

March 1, 2020

Primary Completion

July 31, 2020

Study Completion

March 31, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)