Coronavirus InfectionAIDCONCT04847817
Important Data on COVID-19 Profile in Africa
An observational study of Coronavirus Infection and Africa, run by Centre de Recherche Médicale de Lambaréné at 2 sites in Gabon.
Trial summary
The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus Infection, Africa
- How many people
- 574 participants
- Where
- 2 sitesGabon
- Study dates
- 1 Aug 2020to 1 Mar 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population will consist of volunteer COVID-19 patients hospitalized in referral center for COVID-19 care as well as the household contacts of these hospitalized COVID-19 patients in Gabon, Senegal and Ethiopia.
Who may be able to join
- Molecular (PCR) confirmed COVID-19 patients hospitalized in referral centers,
- Household contacts of hospitalized COVID-19 patient,
- Provided signed informed consent.
Who cannot join
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Gabon2 sites
Centre de Recherches Médicales de Lambréné
Lambaréne
Centre de Recherches Médicales de Lammbaréné
Lambaréné, Moyen-Ogooué Province, 1437
About this study
The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.
Read the detailed description
In this study ,the participants will be enrolled sequentially in the COVID-19 care referral centers. The infected hospitalized patient will be identified by the physicians in hospital. After the patient has given his/her informed consent the permission will be sought from him to approach his household contacts. The household contacts will be screened, and included in the study.
Patients hospitalized and positive for COVID-19 by PCR and their household contacts of all ages and gender (40% minimum of female), will be enrolled upon receipt of written informed consent.
- Conditions
- Coronavirus Infection, Africa
- Keywords
- Coronavirus infection, SARS-CoV, COVID-19, Transmission, Africa
- Medical subject headings
- Coronavirus Infections, Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Index cases | Patients infected by SARS-Cov2 Polymerase Chain Reaction (PCR) and hospitalized in a referral center for COVID-19 . | |
| Households cases | Household contacts of SARS-Cov2 hospitalized COVID-19 patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and biological parameters of COVID-19
Infection and disease progression - Pattern of virus transmission
Measured: 14 days
SARS-CoV-2 transmissibility
proportion of household contact who will become positive for SARS-COV2 using PCR
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Aug 2020
- Primary completion31 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Leiden University Medical Center, Institut de recherche en santé de surveillance épidémiologique et de formation, Université des Sciences de la Santé, Armauer Hansen Research Institute, Ethiopia, Universität Tübingen
- Responsible party
- Sponsor
- Investigators
- Ayôla Akim ADEGNIKA, Principal investigator, Centre de Recherches Médicales de LambarénéMarielle BOUYOU-AKOTET, Principal investigator, Université des Sciences de Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847817
- Sponsor's protocol ID
- 0011/2020/PR/SG/CNE
- Other IDs
- CEI-10/2020
- Acronym
- AIDCO
- Status last verified
- Apr 2021
- First submitted
- 16 Oct 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Individual data sharing
- Yes: Results from our COVID-19 AFRICA, AIDCO, project will be published in peer reviewed journals, seeking rapid and open access publication. This will be done as fast and widely as possible. Results will also be submitted and presented in any national, regional and international scientific meetings and congresses dedicated to COVID-19 online or face to face if, permitted. Before submission for publication or presentation, the review process outlined in the Consortium Agreement and agreed upon by all partners will be followed and care will be taken with respect to intellectual property protection.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Important Data on COVID-19 Profile in Africa
- ClinicalTrials.gov ID
- NCT04847817
- Acronym / sponsor ID
- AIDCO / 0011/2020/PR/SG/CNE
- Conditions
- Coronavirus Infection, Africa
- Keywords
- Coronavirus infection, SARS-CoV, COVID-19, Transmission, Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP), Leiden University Medical Center, Institut de recherche en santé de surveillance épidémiologique et de formation, Université des Sciences de la Santé, Armauer Hansen Research Institute, Ethiopia, Universität Tübingen
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 19 Apr 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.
The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.
Detailed description
In this study ,the participants will be enrolled sequentially in the COVID-19 care referral centers. The infected hospitalized patient will be identified by the physicians in hospital. After the patient has given his/her informed consent the permission will be sought from him to approach his household contacts. The household contacts will be screened, and included in the study.
Patients hospitalized and positive for COVID-19 by PCR and their household contacts of all ages and gender (40% minimum of female), will be enrolled upon receipt of written informed consent.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index cases | – | –Patients infected by SARS-Cov2 Polymerase Chain Reaction (PCR) and hospitalized in a referral center for COVID-19 . |
| Households cases | – | –Household contacts of SARS-Cov2 hospitalized COVID-19 patients. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of volunteer COVID-19 patients hospitalized in referral center for COVID-19 care as well as the household contacts of these hospitalized COVID-19 patients in Gabon, Senegal and Ethiopia.
Key inclusion criteria (3 listed)
- Molecular (PCR) confirmed COVID-19 patients hospitalized in referral centers,
- Household contacts of hospitalized COVID-19 patient,
- Provided signed informed consent.
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical and biological parameters of COVID-19
Time frame: 14 days
Infection and disease progression - Pattern of virus transmission
SARS-CoV-2 transmissibility
Time frame: 14 days
proportion of household contact who will become positive for SARS-COV2 using PCR
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 19 Jul 2022.
- Individual participant dataSharing planned: Yes. Results from our COVID-19 AFRICA, AIDCO, project will be published in peer reviewed journals, seeking rapid and open access publication. This will be done as fast and widely as possible. Results will also be submitted and presented in any national, regional and international scientific meetings and congresses dedicated to COVID-19 online or face to face if, permitted. Before submission for publication or presentation, the review process outlined in the Consortium Agreement and agreed upon by all partners will be followed and care will be taken with respect to intellectual property protection.
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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.
Ayôla Akim ADEGNIKA principal investigator
Centre de Recherches Médicales de Lambaréné
Marielle BOUYOU-AKOTET principal investigator
Université des Sciences de Santé
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection and Africa, run by Centre de Recherche Médicale de Lambaréné at 2 sites 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 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
clinical and biological parameters of COVID-19 (time frame: 14 days). The study lists 2 primary outcomes in all. 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 19 Jul 2022.