NCT04420312

Brief Summary

Multicentric case-control study that is aims at:

  • evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for COVID-19 pneumonia into two large university hospitals in Paris, France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges Pompidou (HEGP)
  • and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,024

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 5, 2020

Last Update Submit

June 23, 2020

Conditions

Keywords

pulmonary embolismcovid-19CTD-DimersARDS

Outcome Measures

Primary Outcomes (1)

  • Impact of PE on COVID-19 patients

    Evaluate the prevalence of Pulmonary embolism among a large population of consecutive COVID-19 patients presenting respiratory symptoms

    March 1st, 2020

Secondary Outcomes (1)

  • Clinical and radiological characteristics

    April 20th,2020

Study Arms (2)

Group 1

Enrolled the Covid-19 patients with a negative CT Pulmonary Angiogram.

Group 2

Enrolled the Covid-19 patients in whom only a CT was performed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged over 18 years, hospitalized for respiratory pathology, associated with the COVID-19; confirmed by either a RT-PCR test or a CT scan.

You may qualify if:

  • patients \>18 years,
  • admitted for acute COVID-19 pneumonia and have recieved a chest CT scan during hospitalization,
  • COVID-19 diagnosis confirmed by a positive result of a RT-PCR,
  • CT findings of COVID-19 pneumonia.

You may not qualify if:

  • Respiratory distress syndrome explained by other cause
  • Patients who refuse to participate to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (26)

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MeSH Terms

Conditions

Pulmonary EmbolismCOVID-19

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Design

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

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

March 1, 2020

Primary Completion

April 20, 2020

Study Completion

April 20, 2020

Last Updated

June 25, 2020

Record last verified: 2020-06

Locations