COVID AMBU 60: Multicentre Observational Study on Management COVID 19 Positive Outpatients in a French Cluster.

Sponsor

Maison de Sante Pluridisciplinaire de Creil (Other)

Overall Status

Unknown status

CT.gov ID

NCT04363099

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

99.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid-19	Other: observational

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Multicentre Observational Study on Management COVID 19 Positive Outpatients in a French Cluster.

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
outpatients COVID 19 positive	Other: observational observational management of outpatients COVID 19

Arm

Intervention/Treatment

outpatients COVID 19 positive

Other: observational

observational management of outpatients COVID 19

Outcome Measures

Primary Outcome Measures

clinical description of covid 19 ambulatory cases. [3 months]

Secondary Outcome Measures

Biological and radiological description of ambulatory cases [3 months]
Prevalence of positive cases (PCR and/or serological positive) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 99 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Msp de Creil	Creil		France	60100

Sponsors and Collaborators

Maison de Sante Pluridisciplinaire de Creil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DIMI Svetlane, Dr, Maison de Sante Pluridisciplinaire de Creil

ClinicalTrials.gov Identifier:

NCT04363099

Other Study ID Numbers:

2020-A01059-30

First Posted:

Apr 27, 2020

Last Update Posted:

Apr 27, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Keywords provided by DIMI Svetlane, Dr, Maison de Sante Pluridisciplinaire de Creil

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 27, 2020