COVID-19 Seroprevalence Study in French Guiana | NCT04490850

Studies
COVID-19 Seroprevalence Study in French Guiana

NCT04490850

Sponsor

Institut Pasteur

Status

Completed

Last Update Posted

Feb 15, 2022Actual

Enrollment

3,541Actual

Phase

Not Applicable

Conditions

Coronavirus Infection
Severe Acute Respiratory Syndrome
SARS-CoV Infection
Covid19

Interventions

Blood sample

Countries

French Guiana

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2020Actual

Primary Completion Date

Sep 24, 2021Actual

Completion Date

Sep 24, 2021Actual

First Submitted Date

Jul 28, 2020

First Submission Date that Met QC Criteria

Jul 28, 2020

First Posted Date

Jul 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

Feb 14, 2022

Last Update Posted Date

Feb 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Institut PasteurINDUSTRY

Collaborators

Name	Class
Institut Pasteur de la Guyane	UNKNOWN
Laboratoire de biologie médicale, Institut Pasteur de la Guyane	UNKNOWN
Laboratoire de biologie médicale de Kourou, French Guiana	UNKNOWN

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

Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.

Detailed Description

This study is a interventional study that present minimal risks and constraints.

The results of the study will allow estimation of COVID-19 virus infection, severity and attack rates, as well as inform public health responses and policy decisions in the French Guiana territory.

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

3,541Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants	Experimental	Blood sample	Procedure: Blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Procedure	Blood sample	Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of the COVID-19 immunity of the population	The COVID-19 immunity of the population will be assessed by evaluating the anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies	1 year

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the level of asymptomatic and pauci-symptomatic infections	The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Person going to a prevention and care center or medical biology analysis laboratory as part of the care, regardless age, regardless of an acute or previous infection with COVID-19;
State of health compatible with a blood sample as defined in the protocol

Exclusion Criteria:

Inability to consent
Person under guardianship or curatorship
Known pathology or a health problem contraindicated with the collect of blood sample.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claude Flamand, PhD	Institut Pasteur de la Guyane, Head of Epidemiology Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Andrée Rosemon		Cayenne			French Guiana
Laboratoire de biologie méicale, Institut Pasteur de la Guyane

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections
D045169	Severe Acute Respiratory Syndrome
D000086382	COVID-19

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided