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

Sponsor
ANRS, Emerging Infectious Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05311891
Collaborator
Institut de Recherche pour le Developpement (Other), Institut National de la Santé Et de la Recherche Médicale, France (Other)
12,600
6
30
2100
2130.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: RT PCR

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 Design

Study Type:
Observational
Anticipated Enrollment :
12600 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
Variants of SARS-CoV-2 in Central and West Africa: Frequency of Circulating Viruses and Implications for the Management and Control of the Pandemic
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre de Référence pour les pathogènes émergents et réémergent Bobo-Dioulasso Burkina Faso BP 2161
    2 Centre Hospitalier Universitaire la Référence Nationale (CHU-RN) N'Djamena Chad BP : 130
    3 Laboratoire National de Santé Publique Brazzaville Brazzaville Congo
    4 CIRBA Abidjan Côte D'Ivoire
    5 Unité Mixte de Recherche CIRMF-SSM Libreville Gabon 20404
    6 SEREFO Bamako Mali BP: 1805

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ANRS, Emerging Infectious Diseases
    ClinicalTrials.gov Identifier:
    NCT05311891
    Other Study ID Numbers:
    • ANRS 0136s
    First Posted:
    Apr 5, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    Mar 1, 2022
    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 May 27, 2022