Remote Assessment of Outpatient With Severe Acute Respiratory Syndrome (SARS-CoV-2)

SARS-CoV2 Infection Clinical Trial

— EVIDENCE  

Official title:

Remote Assessment of Outpatient With SARS-CoV-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125887
• Other study ID #: 87RI21_0033/Evidence
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: June 12, 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Limoges
• Contact: LY Kim, MD
• Phone: 0555058076
• Email: kim.ly[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Outpatient management of patients with a milder form of COVID may be associated to an unfavorable initial or deferred course in relation to the pathology.. Outpatients represent the bulk of patients with COVID-19. To know their evolution, their secondary complications and identifying a profile of "at risk" patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active. This study could make it possible to redefine the follow-up of outpatients. The study consists of a simple questionnaire and possibly a teleconsultation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 12, 2023
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a PCR (polymerase chain reaction assay ) positive for Sars-COV-2 between the start of the pandemic and May 11, 2020
• Outpatient care
• Inclusion 24 months from the date of diagnosis of Sars-COV-2 (± 6 months)

Exclusion Criteria:

• Patients in EHPAD (accommodation facilities for dependent elderly people), home, retirement home, center for disabled people
• Patients under protective measure, curators or guardianship
• Patients with a pathology or condition that does not allow them to express their wishes
• Patients hospitalized when performing PCR or within 10 days with Sars-COV-2

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV2 Infection

Intervention

Other:
• Questionnaire
Patients diagnosed positive for COVID on an outpatient basis will respond to a questionnaire by mail, at 24 month of diagnosis. This questionnaire will make it possible in particular to collect intercurrent events (hospitalization, emergencies, etc.).

Locations

Country	Name	City	State
France	Médecine Interne A	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical procedures	number of medical procedures	At month 24