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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04339686
• Other study ID #: POWER-COVID_CT
• Status: Recruiting
• Start date: April 20, 2020
• Est. completion date: November 2020

Study information

• Verified date: April 2020
• Source: Poitiers University Hospital
• Contact: Guillaume HERPE
• Phone: 681196778
• Email: guillaume.herpe[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56000
• Est. completion date: November 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• All patients suspected of COVID 19 consulting for diagnostic

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Thoracic CT Scan
Retrospective analysis of the thoracic CT scan results compared to final discharge summary

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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