Prevalence of COVID-19 Infection in a Cohort of Patients... | NCT04575545

Studies
Prevalence of COVID-19 Infection in a Cohort of Patients Infected by the HIV and Patients Taking PrEP

NCT04575545

Sponsor

Hôpital Européen Marseille

Status

Unknown status

Last Update Posted

Oct 5, 2020Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Covid19
Virus-HIV

Interventions

Serology test for COVID-19

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2020Estimated

Primary Completion Date

Mar 2021Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Oct 2, 2020

First Submission Date that Met QC Criteria

Oct 2, 2020

First Posted Date

Oct 5, 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

Oct 2, 2020

Last Update Posted Date

Oct 5, 2020Actual

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

The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.

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

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIV positive patients			Diagnostic Test: Serology test for COVID-19
Patients taking PrEP			Diagnostic Test: Serology test for COVID-19

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serology test for COVID-19	Diagnostic Test	ELISA test	HIV positive patients Patients taking PrEP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
% of patients with positive serological tests for covid-19		3 months

Secondary Outcomes

Measure	Description	Time Frame
Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19	% of anti-covid positive cells	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged ≥ 18 years
patients infected by the HIV on treatment
patients taking PreP (Pre-exposure prophylaxis (PrEP))
Being affiliated with or benefiting from a social security scheme

Exclusion Criteria:

Subject to a measure for the protection of justice

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

patients infected by the HIV on treatment and patients taking PreP

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Myriam BENNANI	Contact	0413428351		m.bennani@hopital-europeen.fr

Overall Officials

Name	Affiliation	Role
Patrick PHILIBERT	Hôpital Europeen Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BENNANI		Marseille		13003	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D000163	Acquired Immunodeficiency Syndrome

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
D012698	Serologic Tests

Ancestor Terms

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided