Laboratory Confirmed SARS-CoV-2 Infection Without SymptomsSero-CoVNCT05065632
Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon
An observational study of Laboratory Confirmed SARS-CoV-2 Infection Without Symptoms, run by Prof. Ayola Akim ADEGNIKA at 1 site in Gabon.
Trial summary
Gabon is the 3rd country most affected by COVID-19 behind Cameroon and Democratic Republic of Congo in Central Africa, with 8860 cases and 54 deaths in critically ill patients, since the first confirmed case of COVID-19 on the 10th of March 2020 (https://africacdc.org/covid-19/). Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Laboratory Confirmed SARS-CoV-2 Infection Without Symptoms
- What is being tested?
- Wantai kit Elisa
- How many people
- 3,455 participants
- Where
- 1 siteGabon
- Study dates
- 1 Oct 2021to 31 Dec 2024
- How long will I take part?
- 1 Day
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A total of 3455 people living in Gabon, aged from 1 year, and above will be stratified by age and included in this study
Who may be able to join
- Persons of both sexes aged one year and older and residing for more than three months in the study area are eligible to participate in the study
Who cannot join
- Any person not residing in the locality surveyed or any person residing for less than three months. Refusal to give informed consent and contraindication to venipuncture venipuncture.
Trial locations and contacts
1 site in 1 country.
Rafiou Adamou, Ph.D contact
Gabon1 site, 1 recruiting
- Recruiting
Centre de Recherches Medicales de Lambarene
Lambaréné, 242
Ayola Akim Adegnika, Ph.D, aadegnika@cermel.org
About this study
Official title: Population-based Age-stratified Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon
Gabon is the 3rd country most affected by COVID-19 behind Cameroon and Democratic Republic of Congo in Central Africa, with 8860 cases and 54 deaths in critically ill patients, since the first confirmed case of COVID-19 on the 10th of March 2020 (https://africacdc.org/covid-19/). Most of the individuals infected by SARS-CoV-2 are asymptomatic and they represent a major source of viral spread. To date, African countries have been less affected by deaths caused by the Covid-19 pandemic compared to other countries. It is currently unknown why Africa has avoided more deaths and appears to not simply be due to a lack of testing, since the overall death rate has not increased. Better quality data on seroprevalence in different African regions and proven explanations of the differences between Africa and other continents, are urgently needed. The aim of this study is to learn about the proportion of people after a first pic of transmission, who have been exposed to COVID-19 in Gabon by testing for plasma antibodies to the SARS-CoV-2 virus.
The overall goal of this study is to examine the trend of specific anti-SARS-CoV-2 antibodies in Gabonese population.
Read the detailed description
Based on its technical capacities (ELISA bench and multiparametric flow cytometer), we will provide evident data on the immune responses in Covid-19 infected patients. The quantification of antibodies against SARS-CoV-2 recombinant protein will be done by ELISA using Wantai ELISA total Ab. Meanwhile, data on clinical status will be recorded and classified using WHO patient form. Data obtained will be analyzed by a statistician based at CERMEL using robust models in compliance with the type of data generated.
- Being tested
- Wantai kit Elisa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wantai kit ElisaDiagnostic test
to mesure antibodies against SARSCov-2 recombinant antigen
| Study group | Role | What they receive |
|---|---|---|
| Groupe 1 | [1-15[ Receives: Diagnostic Test: Wantai kit Elisa | |
| Group 2 | [15- 30[ Receives: Diagnostic Test: Wantai kit Elisa | |
| Group 3 | [30-45[ Receives: Diagnostic Test: Wantai kit Elisa | |
| Group 4 | [45-60[ Receives: Diagnostic Test: Wantai kit Elisa | |
| Group 5 | 60+ Receives: Diagnostic Test: Wantai kit Elisa |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroprevelence on SARS-Cov- 2 infection in Gabon
assess the specific anti-SARS-CoV-2 antibodies in individuals and for modeling the evolution of the COVID-19 outbreak.
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laboratory Confirmed SARS-CoV-2 Infection Without SymptomsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,455 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Prof. Ayola Akim ADEGNIKA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné
- Investigators
- Ayola Akim A ADEGNIKA, PhD, Principal investigator, Centre de Recherche Médicale de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065632
- Sponsor's protocol ID
- 0056/2021/P/SG/CNER
- Acronym
- Sero-CoV
- Status last verified
- Jun 2023
- First submitted
- 30 Sep 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-based Age-stratified Seroepidemiological Investigation of Coronavirus 2019 (COVID-19) Infection in Gabon
- ClinicalTrials.gov ID
- NCT05065632
- Acronym / sponsor ID
- Sero-CoV / 0056/2021/P/SG/CNER
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,455 participants (estimated)
- Lead sponsor
- Prof. Ayola Akim ADEGNIKAUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Oct 2021 (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.
Gabon is the 3rd country most affected by COVID-19 behind Cameroon and Democratic Republic of Congo in Central Africa, with 8860 cases and 54 deaths in critically ill patients, since the first confirmed case of COVID-19 on the 10th of March 2020 (https://africacdc.org/covid-19/). Most of the individuals infected by SARS-CoV-2 are asymptomatic and they represent a major source of viral spread. To date, African countries have been less affected by deaths caused by the Covid-19 pandemic compared to other countries. It is currently unknown why Africa has avoided more deaths and appears to not simply be due to a lack of testing, since the overall death rate has not increased. Better quality data on seroprevalence in different African regions and proven explanations of the differences between Africa and other continents, are urgently needed. The aim of this study is to learn about the proportion of people after a first pic of transmission, who have been exposed to COVID-19 in Gabon by testing for plasma antibodies to the SARS-CoV-2 virus.
The overall goal of this study is to examine the trend of specific anti-SARS-CoV-2 antibodies in Gabonese population.
Detailed description
Based on its technical capacities (ELISA bench and multiparametric flow cytometer), we will provide evident data on the immune responses in Covid-19 infected patients. The quantification of antibodies against SARS-CoV-2 recombinant protein will be done by ELISA using Wantai ELISA total Ab. Meanwhile, data on clinical status will be recorded and classified using WHO patient form. Data obtained will be analyzed by a statistician based at CERMEL using robust models in compliance with the type of data generated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Groupe 1 | – | Diagnostic Test: Wantai kit Elisa[1-15[ |
| Group 2 | – | Diagnostic Test: Wantai kit Elisa[15- 30[ |
| Group 3 | – | Diagnostic Test: Wantai kit Elisa[30-45[ |
| Group 4 | – | Diagnostic Test: Wantai kit Elisa[45-60[ |
| Group 5 | – | Diagnostic Test: Wantai kit Elisa60+ |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 3455 people living in Gabon, aged from 1 year, and above will be stratified by age and included in this study
Key inclusion criteria (1 listed)
- Persons of both sexes aged one year and older and residing for more than three months in the study area are eligible to participate in the study
Key exclusion criteria (1 listed)
- Any person not residing in the locality surveyed or any person residing for less than three months. Refusal to give informed consent and contraindication to venipuncture venipuncture.
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 |
|---|---|---|
| Wantai kit Elisato mesure antibodies against SARSCov-2 recombinant antigen | Diagnostic test | Group 2, Group 3, Group 4, Group 5, Groupe 1 |
Primary outcome
seroprevelence on SARS-Cov- 2 infection in Gabon
Time frame: 4 Months
assess the specific anti-SARS-CoV-2 antibodies in individuals and for modeling the evolution of the COVID-19 outbreak.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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.
Rafiou Adamou, Ph.D contact
Ayola Akim A ADEGNIKA, PhD principal investigator
Centre de Recherche Médicale de Lambaréné
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laboratory Confirmed SARS-CoV-2 Infection Without Symptoms, run by Prof. Ayola Akim ADEGNIKA at 1 site in Gabon.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayola A ADEGNIKA, Ph.D (+24177406464, aadegnika@cermel.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seroprevelence on SARS-Cov- 2 infection in Gabon (time frame: 4 Months). 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 22 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.