Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon (Sero-CoV)

June 17, 2023 updated by: Prof. Ayola Akim ADEGNIKA

Population-based Age-stratified Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon

Gabon is the 3rd country most affected by COVID-19 behind Cameroon and Democratic Republic of Congo in Central Africa, with 8860 cases and 54 deaths in critically ill patients, since the first confirmed case of COVID-19 on the 10th of March 2020 (https://africacdc.org/covid-19/). Most of the individuals infected by SARS-CoV-2 are asymptomatic and they represent a major source of viral spread. To date, African countries have been less affected by deaths caused by the Covid-19 pandemic compared to other countries. It is currently unknown why Africa has avoided more deaths and appears to not simply be due to a lack of testing, since the overall death rate has not increased. Better quality data on seroprevalence in different African regions and proven explanations of the differences between Africa and other continents, are urgently needed. The aim of this study is to learn about the proportion of people after a first pic of transmission, who have been exposed to COVID-19 in Gabon by testing for plasma antibodies to the SARS-CoV-2 virus.

The overall goal of this study is to examine the trend of specific anti-SARS-CoV-2 antibodies in Gabonese population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Based on its technical capacities (ELISA bench and multiparametric flow cytometer), we will provide evident data on the immune responses in Covid-19 infected patients. The quantification of antibodies against SARS-CoV-2 recombinant protein will be done by ELISA using Wantai ELISA total Ab. Meanwhile, data on clinical status will be recorded and classified using WHO patient form. Data obtained will be analyzed by a statistician based at CERMEL using robust models in compliance with the type of data generated.

Study Type

Observational

Enrollment (Estimated)

3455

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Gabon
      • Lambaréné, Gabon, 242
        • Recruiting
        • Centre de Recherches Médicales de Lambaréné
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

A total of 3455 people living in Gabon, aged from 1 year, and above will be stratified by age and included in this study

Description

Inclusion Criteria:

  • Persons of both sexes aged one year and older and residing for more than three months in the study area are eligible to participate in the study

Exclusion Criteria:

  • Any person not residing in the locality surveyed or any person residing for less than three months. Refusal to give informed consent and contraindication to venipuncture venipuncture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Groupe 1
[1-15[
Diagnostic test: Wantai kit Elisa
to mesure antibodies against SARSCov-2 recombinant antigen
Group 2
[15- 30[
Diagnostic test: Wantai kit Elisa
to mesure antibodies against SARSCov-2 recombinant antigen
Group 3
[30-45[
Diagnostic test: Wantai kit Elisa
to mesure antibodies against SARSCov-2 recombinant antigen
Group 4
[45-60[
Diagnostic test: Wantai kit Elisa
to mesure antibodies against SARSCov-2 recombinant antigen
Group 5
60+
Diagnostic test: Wantai kit Elisa
to mesure antibodies against SARSCov-2 recombinant antigen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seroprevelence on SARS-Cov- 2 infection in Gabon
Time Frame: 4 Months
assess the specific anti-SARS-CoV-2 antibodies in individuals and for modeling the evolution of the COVID-19 outbreak.
4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Ayola Akim ADEGNIKA

Investigators

  • Principal Investigator: Ayola Akim A ADEGNIKA, PhD, Centre de Recherche Médicale de Lambaréné

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0056/2021/P/SG/CNER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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