Variants of SARS-CoV-2 Causing COVID-19 in Africa

• Conditions: COVID-19
• Interventions: Diagnostic Test: RT PCR

• Registration Number: NCT05311891
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

Detailed Description

The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

The research will combine retrospective and prospective approaches to determine the evolutionary dynamics of the virus since the start of the pandemic. It is planned to sequence the entire Spike protein gene for 1550 viruses and make 300 entire genomes. This work will be supplemented by antibody seroneutralization and respiratory transcriptomics tests, in order to estimate the immuno-virological response of the COVID-19 disease associated with the identified SARS-CoV-2 variants.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-05
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27
• Study Start: 2022-09
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12600

Inclusion Criteria

• Major subject (cf. country)
• Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not
• Not objecting to participating in the research

Read More

Exclusion Criteria

• NA

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective	RT PCR	12000 participants positive for SARS-COV-2
Prospective	RT PCR	600 participants positive for SARS-COV-2

Primary Outcome Measures

Name	Time	Method
Number of SARS-CoV-2 sequences generated partially and in whole genome	Through study completion, an average of 1 year.	This outcome represent our main gaol and will include sequences that were partially generated in the Spike proteine and full genomes as well. Our current target is 1550 sequences.

Secondary Outcome Measures

Name	Time	Method
Number of new SARS-CoV-2 variants identify	Through study completion, an average of 1 year.	This outcome represents the number of new viruses that are identified at the end of the study and have not been reported previously.
Number of individuals tested positive for COVID-19	Up to six months	This outcome will be focused on the number of persons that will be tested positive for COVID-19 throughout the study, using SARS-CoV-2 rapid antigen tests. We planned to screen 12000 individuals overall in the six participating countries.

Trial Locations

Locations (6)

Laboratoire National de Santé Publique Brazzaville; 🇨🇬 Brazzaville, Congo

SEREFO; 🇲🇱 Bamako, Mali

CIRBA; 🇨🇮 Abidjan, Côte D'Ivoire

Unité Mixte de Recherche CIRMF-SSM; 🇬🇦 Libreville, Gabon

Centre de Référence pour les pathogènes émergents et réémergent; 🇧🇫 Bobo-Dioulasso, Burkina Faso

Centre Hospitalier Universitaire la Référence Nationale (CHU-RN); 🇹🇩 N'Djamena, Chad