Impact of the CT Scan in Patients With Suspected Covid-19 | NCT05079191

Studies
Impact of the CT Scan in Patients With Suspected Covid-19

NCT05079191

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Nov 3, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Nov 2021Estimated

Completion Date

Nov 30, 2021Estimated

First Submitted Date

Oct 14, 2021

First Submission Date that Met QC Criteria

Oct 14, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2021

Last Update Posted Date

Nov 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The diagnostic performance of the scanner in the indication of suspected Covid-19 is not yet well known, especially in comparison with the results of RT-PCR.

The potential use of the scanner as a tool for quantifying the severity of Covid-19 disease is not yet well established, especially the variations between readers or between measurement techniques.

The impact of the scanner in predicting the fate of patients with confirmed Covid-19 is not yet known.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study of the chest scanner in suspected Covid-19		Files analysed retrospectively from March 01, 2020 to April 29, 2020 will be examined]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Adult patient (≥18 years old)
Patient admitted to Strasbourg University Hospitals for suspicion of Covid-19, between 03/01/2020 and 04/29/2020
Availability of at least one chest CT scan during hospitalization
Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Non-inclusion criteria

Patient who expressed his opposition to participating in the study
Patient under legal protection
Patient under guardianship or guardianship

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patient admitted to Strasbourg University Hospitals for suspicion of Covid-19

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mickaël OHANA, MD, PhD	Contact	33 3 69 55 11 17		mickael.ohana@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact			said.chayer@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Radiologie B - Hôpitaux Universitaires de Strasbourg	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided