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

COVID-19 Clinical Trial

— South-Spike  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05311891
• Other study ID #: ANRS 0136s
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: October 2022

Study information

• Verified date: March 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12600
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Burkina Faso	Centre de Référence pour les pathogènes émergents et réémergent	Bobo-Dioulasso
Chad	Centre Hospitalier Universitaire la Référence Nationale (CHU-RN)	N'Djamena
Congo	Laboratoire National de Santé Publique Brazzaville	Brazzaville
Côte D'Ivoire	CIRBA	Abidjan
Gabon	Unité Mixte de Recherche CIRMF-SSM	Libreville
Mali	SEREFO	Bamako

Sponsors (3)

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

Countries where clinical trial is conducted

Burkina Faso,  Chad,  Congo,  Côte D'Ivoire,  Gabon,  Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of individuals tested positive for COVID-19	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
Secondary	Number of new SARS-CoV-2 variants identify	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.