Prospective Evaluation of the Predictive Criteria of Seve... | NCT04615676

Studies
Prospective Evaluation of the Predictive Criteria of Severity for Respiratory Infection Due to COVID-19 Virus

NCT04615676

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

Nov 9, 2020Actual

Enrollment

4,734Actual

Phase

Not provided

Conditions

SARS-CoV2

Interventions

Follow-up phone call

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2020Actual

Primary Completion Date

Jul 17, 2020Actual

Completion Date

Jul 17, 2020Actual

First Submitted Date

Nov 3, 2020

First Submission Date that Met QC Criteria

Nov 3, 2020

First Posted Date

Nov 4, 2020Actual

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

Nov 6, 2020

Last Update Posted Date

Nov 9, 2020Actual

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

Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.

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

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,734Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow-up phone call	Other	Follow-up phone call after month to detect which patient have been hospitalized

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization	Hospitalization declared by the patient 1 month after his call to the emergency call center	Month 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID

Exclusion Criteria:

unknown contact facility
call not regulated by a practitioner from the medical emergency help team

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles-Henri HOUZE-CERFON	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Toulouse		Toulouse		31000	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided