Multicentre Observational Study on Management COVID 19 Po... | NCT04363099

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

NCT04363099

Sponsor

Maison de Sante Pluridisciplinaire de Creil

Status

Unknown status

Last Update Posted

Apr 27, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Covid-19

Interventions

observational

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Jun 30, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 23, 2020

First Posted Date

Apr 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2020

Last Update Posted Date

Apr 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

DIMI Svetlane, Dr, Maison de Sante Pluridisciplinaire de CreilPrincipal Investigator

Lead Sponsor

Maison de Sante Pluridisciplinaire de CreilOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
outpatients COVID 19 positive			Other: observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational	Other	observational management of outpatients COVID 19	outpatients COVID 19 positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical description of covid 19 ambulatory cases.		3 months

Secondary Outcomes

Measure	Description	Time Frame
Biological and radiological description of ambulatory cases		3 months
Prevalence of positive cases (PCR and/or serological positive)		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

ambulatory patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Svetlane DIMI, M.D	Contact	+33650002085		svetlane.dimi@sfr.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Msp de Creil	Recruiting	Creil		60100	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided