NCT04339686

Brief Summary

All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health. To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID. CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary. Ct Scan performance will be recorded and analyzed.

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
56,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

April 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 8, 2020

Last Update Submit

April 27, 2020

Conditions

The Gold Standard for Current SARS CoV2 Detection is RT-PCR

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of chest CT in screening for pulmonary lesions in clinical suspicions of COVID.

    CT Report will dichotomized into evocative or non-evocative for COVID-related lung injury.

    1 month

Secondary Outcomes (1)

  • Compare the diagnostic performance of chest CT and RT-PCR in COVID 19 at the initial consultation (screening).

    1 month

Study Arms (1)

Suspicion of COVID 19

Diagnostic Test: Thoracic CT Scan

Interventions

Thoracic CT ScanDIAGNOSTIC_TEST

Retrospective analysis of the thoracic CT scan results compared to final discharge summary

Suspicion of COVID 19

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients suspected of COVID 19 consulting for diagnostic

You may qualify if:

  • All patients suspected of COVID 19 consulting for diagnostic

You may not qualify if:

  • Delay between RT-PCR and Thoracic Scan greater than 6 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Poitiers

Poitiers, France

RECRUITING

Central Study Contacts

Guillaume HERPE

CONTACT

681196778guillaume.herpe@chu-poitiers.fr

Study Design

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

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 9, 2020

Study Start

April 20, 2020

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)