Variants of SARS-CoV-2 Causing COVID-19 in Africa (South-Spike)

May 26, 2022 updated by: ANRS, Emerging Infectious Diseases

Variants of SARS-CoV-2 in Central and West Africa: Frequency of Circulating Viruses and Implications for the Management and Control of the Pandemic

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

12600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Bobo-Dioulasso, Burkina Faso, BP 2161
        • Centre de Référence pour les pathogènes émergents et réémergent
        • Contact:
  • Chad
      • N'Djamena, Chad, BP : 130
        • Centre Hospitalier Universitaire la Référence Nationale (CHU-RN)
  • Congo
      • Brazzaville, Congo
        • Laboratoire National de Santé Publique Brazzaville
  • Côte D'Ivoire
      • Abidjan, Côte D'Ivoire
  • Gabon
      • Libreville, Gabon, 20404
        • Unité Mixte de Recherche CIRMF-SSM
        • Contact:
  • Mali
      • Bamako, Mali, BP: 1805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective
12000 participants positive for SARS-COV-2
Diagnostic test: RT PCR
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
Other Names:
  • Sequencing of the S gene
  • Sequencing of the entire SARS-COV-2 genome
  • Seroneutralization of antibodies
  • Respiratory transcriptomics
Prospective
600 participants positive for SARS-COV-2
Diagnostic test: RT PCR
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
Other Names:
  • Sequencing of the S gene
  • Sequencing of the entire SARS-COV-2 genome
  • Seroneutralization of antibodies
  • Respiratory transcriptomics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of SARS-CoV-2 sequences generated partially and in whole genome
Time Frame: 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.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of individuals tested positive for COVID-19
Time Frame: 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.
Up to six months
Number of new SARS-CoV-2 variants identify
Time Frame: 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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Institut de Recherche pour le Developpement

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 0136s

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe