Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening.

Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening. Comparison to Virological Testing and Multiparametric Gold Standard

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.

Study Overview

• Status: Unknown
• Conditions: The Gold Standard for Current SARS CoV2 Detection is RT-PCR
• Intervention / Treatment: Diagnostic test: Thoracic CT Scan

• Study Type: Observational
• Enrollment (Anticipated): 56000

Contacts and Locations

Study Locations

• France
  • Poitiers, France
    • Recruiting
    • CHU de Poitiers
    • Contact: Guillaume HERPE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients suspected of COVID 19 consulting for diagnostic

Description

Inclusion Criteria:

• All patients suspected of COVID 19 consulting for diagnostic

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspicion of COVID 19	Diagnostic test: Thoracic CT Scan; Retrospective analysis of the thoracic CT scan results compared to final discharge summary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the diagnostic performance of chest CT and RT-PCR in COVID 19 at the initial consultation (screening).	Initial virological RT-PCR results: positive or negative depending on the laboratories of the institutions. Scanner results according to French Thoracic Imaging Society.	1 month

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2020
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (ACTUAL): April 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: POWER-COVID_CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No