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RecruitingNCT05065632Sero-CoVUpdated Jun 22, 2023

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

An observational study in Laboratory Confirmed SARS-CoV-2 Infection Without Symptoms, sponsored by Prof. Ayola Akim ADEGNIKA. Recruiting at 1 site in Gabon. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Prof. Ayola Akim ADEGNIKA · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
3,455
Ages
1 Year and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Laboratory Confirmed SARS-CoV-2 Infection Without Symptoms
03

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
3,455 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Groupe 1

    \[1-15\[

    Diagnostic Test: Wantai kit Elisa

  • Group 2

    \[15- 30\[

    Diagnostic Test: Wantai kit Elisa

  • Group 3

    \[30-45\[

    Diagnostic Test: Wantai kit Elisa

  • Group 4

    \[45-60\[

    Diagnostic Test: Wantai kit Elisa

  • Group 5

    60+

    Diagnostic Test: Wantai kit Elisa

Interventions

  • Diagnostic testWantai kit Elisa

    to mesure antibodies against SARSCov-2 recombinant antigen

05

What researchers measure

Primary outcomes

  1. seroprevelence on SARS-Cov- 2 infection in Gabon

    assess the specific anti-SARS-CoV-2 antibodies in individuals and for modeling the evolution of the COVID-19 outbreak.

    Time frame: 4 Months

06

Study locations

1 of 1 sites recruiting
  • Centre de Recherches Medicales de Lambarene
    Lambaréné, 242, Gabon
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05065632
Lead sponsor
Prof. Ayola Akim ADEGNIKA
Responsible party
Prof. Ayola Akim ADEGNIKA (Prof. Dr, Centre de Recherche Médicale de Lambaréné) — Sponsor-investigator
First posted
Oct 4, 2021
Start date
Oct 1, 2021
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 22, 2023

Study contacts

Ayola A ADEGNIKA, Ph.D
Contact
aadegnika@cermel.org
+24177406464
Rafiou Adamou, Ph.D
Contact
adamou.rafiou@gmail.com
Ayola Akim A ADEGNIKA, PhD
principal investigator · Centre de Recherche Médicale de Lambaréné

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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