NCT05065632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.2 years

First QC Date

September 30, 2021

Last Update Submit

June 17, 2023

Conditions

Outcome Measures

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.

    4 Months

Study Arms (5)

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

Wantai kit ElisaDIAGNOSTIC_TEST

to mesure antibodies against SARSCov-2 recombinant antigen

Group 2Group 3Group 4Group 5Groupe 1

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherches Medicales de Lambarene

Lambaréné, 242, Gabon

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous Blood

Study Officials

  • Ayola Akim A ADEGNIKA, PhD

    Centre de Recherche Médicale de Lambaréné

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayola A ADEGNIKA, Ph.D

CONTACT

Rafiou Adamou, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 4, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations