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

Sponsor
Prof. Ayola Akim ADEGNIKA (Other)
Overall Status
Recruiting
CT.gov ID
NCT05065632
Collaborator
(none)
3,455
1
17.9
192.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Wantai kit Elisa

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3455 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Population-based Age-stratified Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. seroprevelence on SARS-Cov- 2 infection in Gabon [4 Months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre de Recherches Medicales de Lambarene Lambaréné Gabon 242

Sponsors and Collaborators

  • Prof. Ayola Akim ADEGNIKA

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Ayola Akim ADEGNIKA, Prof. Dr, Centre de Recherche Médicale de Lambaréné
ClinicalTrials.gov Identifier:
NCT05065632
Other Study ID Numbers:
  • 0056/2021/P/SG/CNER
First Posted:
Oct 4, 2021
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022