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

NCT05311891 | Unknown

• 1 other identifier: ANRS 0136s
• Study Type: observational
• Target: 12,600
• Locations: 6 countries
• Sites: 6

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of SARS-CoV-2 sequences generated partially and in whole genome

  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.

  Through study completion, an average of 1 year.

Secondary Outcomes (2)

• Number of individuals tested positive for COVID-19

  Up to six months

• Number of new SARS-CoV-2 variants identify

  Through study completion, an average of 1 year.

Study Arms (2)

Retrospective

12000 participants positive for SARS-COV-2

Diagnostic Test: RT PCR

Prospective

600 participants positive for SARS-COV-2

Diagnostic Test: RT PCR

Interventions

RT PCR DIAGNOSTIC_TEST

Characterize the different molecular variants of SARS-CoV-2, determine the escape potential of the new variants from neutralization by monoclonal antibodies and currently available vaccines and characterization of the mRNAs expressed in infected persons

Also known as: Sequencing of the S gene, Sequencing of the entire SARS-COV-2 genome, Seroneutralization of antibodies, Respiratory transcriptomics

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participant presenting for a SARS COV2 diagnosis, with or without symptoms

You may qualify if:

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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut de Recherche pour le Developpement: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (6)

Centre de Référence pour les pathogènes émergents et réémergent

Bobo-Dioulasso, BP 2161, Burkina Faso

Location

Centre Hospitalier Universitaire la Référence Nationale (CHU-RN)

N'Djamena, BP : 130, Chad

Location

CIRBA

Abidjan, Côte d’Ivoire

Location

Unité Mixte de Recherche CIRMF-SSM

Libreville, 20404, Gabon

Location

SEREFO

Bamako, BP: 1805, Mali

Location

Laboratoire National de Santé Publique Brazzaville

Brazzaville, Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal sample (virus)

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 5, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-03

Locations

GA (1); RE (1); CÔ (1); CH (1); MA (1); BU (1)