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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Ayola Akim ADEGNIKA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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