NCT05125887

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2023

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

November 11, 2021

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medical procedures

    number of medical procedures

    At month 24

Interventions

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.).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who had a positive PCR (polymerase chain reaction assay ) meeting the eligibility criteria could be included

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Médecine Interne A

Limoges, 87000, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 18, 2021

Study Start

February 1, 2022

Primary Completion

December 12, 2022

Study Completion

June 12, 2023

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations