Morbi-mortality by COVID-19 Among Homeless People in Mars... | NCT04408131

Studies
Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study

NCT04408131

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Withdrawn

Last Update Posted

May 31, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Homeless

Interventions

Blood sample
Blood sample

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

ID	Type	Description	Link
2020-A01398-31	Other Identifier	ID RCB

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study not started

Expanded Access Info

Start Date

May 28, 2020Actual

Primary Completion Date

Jan 27, 2021Estimated

Completion Date

May 30, 2023Actual

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

May 29, 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

May 30, 2023

Last Update Posted Date

May 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.

The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).

Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Homeless people	Experimental	Blood sample	Biological: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Biological	virological test	Homeless people
Blood sample

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the covid mortality rate	The mortality rate is determined by the initial clinical diagnosis and follow-up of the patient by the field team.	90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Living in the city of Marseille
Being homeless
Be over 18 years of age

Exclusion Criteria:

Persons under guardianship
Persons who refused to sign the research consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Olivier ARNAUD, Director	Assistance Publique Hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hôpitaux de Marseille		Marseille	PACA	13354	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36822808	Derived	Mosnier E, Loubiere S, Monfardini E, Alibert A, Landier J, Ninoves L, Bosetti T, Auquier P, Mosnier M, Wakap SN, Warszawski J, Tinland A. Cumulative incidence of SARS-CoV-2 infection within the homeless population: insights from a city-wide longitudinal study. BMJ Open. 2023 Feb 23;13(2):e065734. doi: 10.1136/bmjopen-2022-065734.

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis