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NCT05124145 Clinical Trial

Primary Care in AURA for COVID-19

COVID-19 Pandemic Clinical Trial

— SOPRAC  

Official title:
Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05124145
Other study ID # SOPRAC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2020
Est. completion date November 5, 2021

Study information
Verified date November 2021
Source Research on Healthcare Performance Lab U1290
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7000
Est. completion date November 5, 2021
Est. primary completion date November 2, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention (surveillance system)
The surveillance network will collect data on all consecutive COVID-19 cases

Locations
Country Name City State
France RESHAPE Lyon

Sponsors (1)
Lead Sponsor Collaborator
Research on Healthcare Performance Lab U1290

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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