Primary Care in AURA for COVID-19 | NCT05124145

Studies
Primary Care in AURA for COVID-19

NCT05124145

Sponsor

Research on Healthcare Performance Lab U1290

Status

Completed

Last Update Posted

Nov 26, 2021Actual

Enrollment

7,000Actual

Phase

Not provided

Conditions

Primary Care : Suspected and Confirmed Cases of COVID-19
Primary Health Care
COVID-19 Pandemic

Interventions

No intervention (surveillance system)

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 2021

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 1, 2020Actual

Primary Completion Date

Nov 2, 2020Actual

Completion Date

Nov 5, 2021Actual

First Submitted Date

Nov 16, 2021

First Submission Date that Met QC Criteria

Nov 16, 2021

First Posted Date

Nov 17, 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

Nov 17, 2021

Last Update Posted Date

Nov 26, 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

As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.

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

7,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surveillance network		The surveillance network is made of 200 health professionals from 85 practices	Other: No intervention (surveillance system)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention (surveillance system)	Other	The surveillance network will collect data on all consecutive COVID-19 cases	surveillance network

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimation of the weekly incidence of COVID-19 confirmed cases	Confirmed cases will be defined by the positivity of the detection of SARS-CoV-2 in RT-PCR and possibly by serology (for patients in whom a test is performed). The incidence rate of confirmed cases will be estimated from the number of new cases confirmed by a positive biological test reported in the patient population of the participating facilities.	30 days after the COVID-19 suspected

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspect or confirmed COVID-19 case consulting in primary care in the Aura region

Exclusion Criteria:

Patient with a COVID-19 diagnosis excluded after clinical examination or investigation.
Patient refusing to participate to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients consulting a health professional in primary care in the AURA region, by physical encounter, visio-consultation or telephone call, during the COVID-19 epidemics period

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurent LETRILLART, MD, PhD	Research on Healthcare Performance Lab U1290	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RESHAPE		Lyon		69373	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