COVID-19South-SpikeNCT05311891
Variants of SARS-CoV-2 Causing COVID-19 in Africa
An observational study of COVID-19, run by ANRS, Emerging Infectious Diseases at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- RT PCR
- Type of treatment
- Vaccines
- How many people
- 12,600 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 30 Sep 2022to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participant presenting for a SARS COV2 diagnosis, with or without symptoms
Who may be able to join
- Major subject (cf. country)
- Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not
- Not objecting to participating in the research
Who cannot join
- NA
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Burkina Faso1 site
Centre de Référence pour les pathogènes émergents et réémergent
Bobo-Dioulasso, BP 2161
Chad1 site
Centre Hospitalier Universitaire la Référence Nationale (CHU-RN)
N'Djamena, BP : 130
Republic of the Congo1 site
Laboratoire National de Santé Publique Brazzaville
Brazzaville
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- RT PCR
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT PCRDiagnostic test
Also called Sequencing of the S gene, Sequencing of the entire SARS-COV-2 genome, Seroneutralization of antibodies, Respiratory transcriptomics
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
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | 12000 participants positive for SARS-COV-2 Receives: Diagnostic Test: RT PCR | |
| Prospective | 600 participants positive for SARS-COV-2 Receives: Diagnostic Test: RT PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (2)
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.
Measured: Up to six months
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start30 Sep 2022
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Institut de Recherche pour le Developpement, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311891
- Sponsor's protocol ID
- ANRS 0136s South Spike
- Acronym
- South-Spike
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05311891
- Acronym / sponsor ID
- South-Spike / ANRS 0136s South Spike
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,600 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut de Recherche pour le Developpement, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Diagnostic Test: RT PCR12000 participants positive for SARS-COV-2 |
| Prospective | – | Diagnostic Test: RT PCR600 participants positive for SARS-COV-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participant presenting for a SARS COV2 diagnosis, with or without symptoms
Key inclusion criteria (3 listed)
- Major subject (cf. country)
- Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not
- Not objecting to participating in the research
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT PCRAlso: Sequencing of the S gene, Sequencing of the entire SARS-COV-2 genome, Seroneutralization of antibodies, Respiratory transcriptomicsCharacterize 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 | Diagnostic test | Prospective, Retrospective |
Primary outcome
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.
2 secondary outcomes
Number of individuals tested positive for COVID-19
Time frame: Up to six months
Number of new SARS-CoV-2 variants identify
Time frame: Through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by ANRS, Emerging Infectious Diseases at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Burkina Faso, Chad, Côte d’Ivoire, Gabon, Mali and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SARS-CoV-2 sequences generated partially and in whole genome (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.