NCT04363099

Brief Summary

Since December 2019, a new agent, the coronavirus SARS-Cov-2, has spread from China to the rest of the world causing an international epidemic of respiratory diseases called COVID-19. Oise was one of the first clusters in France, with more than 4,000 confirmed cases. A significant proportion (80%) of patients with COVID-19 are ambulatory. However, few data are available for this particular population in France. Thus, few clear recommendations are available. We propose to conduct a large cohort of observation of suspected or confirmed COVID-19 patients on an ambulatory basis in the Oise region. This observatory will make it possible to describe the epidemiological characteristics and initial management of COVID-19 patients and to identify early severity factors.

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 23, 2020

Last Update Submit

April 23, 2020

Conditions

Covid-19

Keywords

ambulatoryoutpatientsCOVID 19Oise, France

Outcome Measures

Primary Outcomes (1)

  • clinical description of covid 19 ambulatory cases.

    3 months

Secondary Outcomes (2)

  • Biological and radiological description of ambulatory cases

    3 months

  • Prevalence of positive cases (PCR and/or serological positive)

    3 months

Study Arms (1)

outpatients COVID 19 positive

Other: observational

Interventions

observationalOTHER

observational management of outpatients COVID 19

outpatients COVID 19 positive

Eligibility Criteria

AgeUp to 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ambulatory patients

You may qualify if:

  • patients with covid 19 symptoms
  • patients who had a contact with a person PCR Covid 19+

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Msp de Creil

Creil, 60100, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Svetlane DIMI, M.D

CONTACT

+33650002085svetlane.dimi@sfr.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

March 1, 2020

Primary Completion

June 30, 2020

Study Completion

December 31, 2020

Last Updated

April 27, 2020

Record last verified: 2020-04

Locations

FR(1)