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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT05125887

Collaborator

(none)

400

Enrollment

Location

16.3

Anticipated Duration (Months)

24.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV2 Infection	Other: Questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Remote Assessment of Outpatient With SARS-CoV-2

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 12, 2022

Anticipated Study Completion Date :

Jun 12, 2023

Outcome Measures

Primary Outcome Measures

Medical procedures [At month 24]
number of medical procedures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Médecine Interne A	Limoges		France	87000

Sponsors and Collaborators

University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Limoges

ClinicalTrials.gov Identifier:

NCT05125887

Other Study ID Numbers:

87RI21_0033/Evidence

First Posted:

Nov 18, 2021

Last Update Posted:

May 4, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 4, 2022