Back to resultsCOVID-19 Seroprevalence Study in French Guiana (EPI-COVID-POP)
Primary Purpose
Coronavirus Infection, Severe Acute Respiratory Syndrome, SARS-CoV Infection
Status
Completed
Phase
Not Applicable
Locations
French Guiana
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional prevention trial for Coronavirus Infection focused on measuring SARS-CoV-2, COVID-19, Serology, French Guiana
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.
Sites / Locations
- Centre Hospitalier Andrée Rosemon
- Laboratoire de biologie méicale, Institut Pasteur de la Guyane
- Laboratoires Eurofins Guyane
- Laboratoire de biologie médicale de Kourou
- Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants
Arm Description
Blood sample
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Evaluation of the level of asymptomatic and pauci-symptomatic infections
The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population
Full Information
NCT ID
NCT04490850
First Posted
July 28, 2020
Last Updated
February 14, 2022
Sponsor
Institut Pasteur
Collaborators
Institut Pasteur de la Guyane, Laboratoire de biologie médicale, Institut Pasteur de la Guyane, Laboratoire de biologie médicale de Kourou, French Guiana, Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni, French Guiana, Eurofins, Centres Délocalisés de Prévention et de Soins, Centre Hospitalier Andrée Rosemon de Cayenne, Frech Guiana
1. Study Identification
Unique Protocol Identification Number
NCT04490850
Brief Title
COVID-19 Seroprevalence Study in French Guiana
Acronym
EPI-COVID-POP
Official Title
COVID-19 Seroprevalence Study in French Guiana
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
September 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Pasteur
Collaborators
Institut Pasteur de la Guyane, Laboratoire de biologie médicale, Institut Pasteur de la Guyane, Laboratoire de biologie médicale de Kourou, French Guiana, Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni, French Guiana, Eurofins, Centres Délocalisés de Prévention et de Soins, Centre Hospitalier Andrée Rosemon de Cayenne, Frech Guiana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Severe Acute Respiratory Syndrome, SARS-CoV Infection, Covid19
Keywords
SARS-CoV-2, COVID-19, Serology, French Guiana
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3541 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Experimental
Arm Description
Blood sample
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
Blood sample
Primary Outcome Measure Information:
Title
Measure of the COVID-19 immunity of the population
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of the level of asymptomatic and pauci-symptomatic infections
Description
The proportion of asymptomatic and pauci-symptomatic infections will be measured in the population
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Flamand, PhD
Organizational Affiliation
Institut Pasteur de la Guyane, Head of Epidemiology Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Andrée Rosemon
City
Cayenne
Country
French Guiana
Facility Name
Laboratoire de biologie méicale, Institut Pasteur de la Guyane
City
Cayenne
Country
French Guiana
Facility Name
Laboratoires Eurofins Guyane
City
Cayenne
Country
French Guiana
Facility Name
Laboratoire de biologie médicale de Kourou
City
Kourou
Country
French Guiana
Facility Name
Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni
City
Saint-Laurent du Maroni
Country
French Guiana
12. IPD Sharing Statement
Learn more about this trial
COVID-19 Seroprevalence Study in French Guiana
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