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Covid19BAMACOVNCT04710316

Study of COVID-19 Outbreak in Hospital Departments of Bamako, Mali

A study testing SARS-CoV-2 screening by molecular biology and Serological screening in people with Covid19, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in Mali.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The new coronavirus known as SARS-Cov-2 (severe acute respiratory syndrome -coronavirus 2) was first reported in December 2019 and rapidly became a public health emergency. The COVID-19 pandemic is now affecting sensitive regions with fragile health care systems, such as South America and Africa. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
SARS-CoV-2 screening by molecular biology and Serological screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
4 sitesMali
Study dates
15 Feb 2021to 30 Sep 2022
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Free and informed consent accepted in writing
  • Patient: patient hospitalized in one of the four hospitals of Bamako, with clinical signs of infection of the upper or lower respiratory tracts (sore throat, cough/sputum, nasal congestion and rhinorrhea, odynophagia, thoracic oppression, dyspnea, desaturation) with fever or feeling of fever or any other signs of SARS-Cov-2 infection (that is to say the following clinical manifestations, of sudden onset: unexplained asthenia, unexplained myalgia, headache without a known migraine disease, anosmia or hyposmia without associated rhinitis, dysgueusia, diarrhea, heart rhythm disorders, acute myocardial injury, severe thromboembolic event) or who have been in close contact with a SARS-CoV-2 infected person without effective protective measures (FFP2/surgical masks or physical separation) and defined as follows: having shared the same place of life as the confirmed case, for example: family, same room or having a direct contact in face to face with less than 1 meter from the confirmed case during a talk; intimate friends; class or office neighbours; adjacent to the index case in a plane or a train; or having provided or received hygiene or care acts from a confirmed case.
  • Caregivers: caregivers of one of the four hospitals of Bamako

Who cannot join

  • Persons subject to legal protection or not able to give a free and informed consent.
  • Caregivers: caregivers not able to follow the project schedule

Trial locations and contacts

4 sites in 1 country.

Mali4 sites

  • Hopital du Point-G

    Bamako

  • Hopital Gabriel Toure

    Bamako

  • Hôpital dermatologique de Bamako

    Bamako

  • Hôpital du Mali

    Bamako

Other trials in Mali

About this study

Official title: Étude de l'épidémie de SARS-CoV-2 Dans Les Services Hospitaliers de Bamako, Mali

The new coronavirus known as SARS-Cov-2 (severe acute respiratory syndrome -coronavirus 2) was first reported in December 2019 and rapidly became a public health emergency. The COVID-19 pandemic is now affecting sensitive regions with fragile health care systems, such as South America and Africa. Caregivers, in the front line of Covid19 patient management, may accidentally become infected and a source of infection during the incubation phase or in case of asymptomatic infection.

The objectives of this project are thus i) to assess SARS-Cov-2 spread over the hospital departments of Bamako by carrying out a systematic molecular screening of patients and caregivers, ii) to evaluate the feasibility of Point-Of-Care molecular assays in Mali and iii) to estimate the immunity acquired from SARS-Cov-2 among health workers through serological testing, allowing also the assessment of asymptomatic caregiver rate and absence of re-infection among the immunized caregivers. Finally, iv) variability of the virus over time and spread of different variants around the world will be studied by sequencing the viral genome.

Conditions
Covid19
Being tested
SARS-CoV-2 screening by molecular biology, Serological screening
Keywords
Covid-19, SARS-CoV-2, Mali, Africa, Hospital
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 screening by molecular biologyDiagnostic test

    SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome

  • Serological screeningDiagnostic test

    Serological screening of caregivers at D0, M1, M2, M3 (anti-nucleocapsid antibodies).

Study groups in NCT04710316
Study groupRoleWhat they receive
PatientsExperimental- Hospitalized patients in one of the four centers in Bamako, with clinical signs of infection of the upper or lower respiratory tracts with fever or feeling of fever or any other signs of SARS-Cov-2 infection or who have been in close contact with a SARS-CoV-2 infected person without effective protective measures
Receives: Diagnostic Test: SARS-CoV-2 screening by molecular biology
CaregiversExperimentalCaregivers of one of the four centers in Bamako. * Serological screening: all. * Molecular screening: with clinical signs of infection of the upper or lower respiratory tracts with fever or feeling of fever or any other signs of SARS-Cov-2 infection or who have seroconverted to SARS-CoV-2 or who have been in close contact with a SARS-CoV-2 infected person without effective protective measures
Receives: Diagnostic Test: SARS-CoV-2 screening by molecular biology; Diagnostic Test: Serological screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of positive SARS-Cov-2 RT-PCR in Bamako hospital departments during the study

    Positive SARS-Cov-2 RT-PCRs are defined by the detection of SARS-Cov-2 genome after amplification using a test targeting 2 regions of the genome.

    Measured: Through the completion of subject participation (up to 15 months after study start date).

Secondary outcomes (6)

  1. Number of Cepheid Xpert® Xpress SARS-Cov-2 cartridges available for 19.8 USD/number required for the project

    Measured: Through the completion of subject participation (up to 15 months after study start date).

  2. Percentage of positive serological tests among the caregivers of the hospital departments of Bamako.

    Measured: Assessed on the fourth serological assay performed (at Month 3).

  3. Percentage of caregivers asymptomatic but immunized to SARS-CoV-2

    Measured: Assessed on the fourth serological assay performed (at Month 3).

  4. Percentage of caregivers immunized and re-infected with SARS-CoV-2

    Measured: Through the completion of caregiver participation (up to 15 months after study start date).

  5. Number of SARS-CoV-2 mutations/variants detected during the study

    Measured: Through the completion of subject participation (up to 15 months after study start date).

  6. Percentage of SARS-CoV-2 mutations/variants detected during the study

    Measured: Through the completion of subject participation (up to 15 months after study start date).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2021
  2. Study start15 Feb 2021
  3. Primary completion30 Apr 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Interventions * Serological screening of caregivers at D0, M1, M2, M3. * Screening of patients by molecular biology: a nasopharyngeal swab will be performed to symptomatic hospitalized patients or who have been in close contact with a SARS-CoV-2 infected person without effective protective measures to search for SARS-CoV-2 genome. Positive clinical isolates will be sequenced. * Screening of caregivers by molecular biology: a nasopharyngeal swab will be performed to symptomatic caregivers or who have seroconverted to SARS-CoV-2 or who have been in close contact with a SARS-CoV-2 infected person without effective protective measures to search for SARS-CoV-2 genome. Positive clinical isolates will be sequenced.
Masking
None (open label)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04710316
Sponsor's protocol ID
C20-41
Acronym
BAMACOV
Status last verified
Jan 2025
First submitted
8 Jan 2021
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maiga AI, Saliou M, Kodio A, Traore AM, Dabo G, Flandre P, Fofana DB, Ammour K, Tra NOME, Dolo O, Marcelin AG, Todesco E. High SARS-CoV-2 seroprevalence among health care workers in Bamako referral hospitals: a prospective multisite cross-sectional study (ANRS COV11). Clin Microbiol Infect. 2022 Jun;28(6):900-902. doi: 10.1016/j.cmi.2022.02.019. Epub 2022 Feb 16. No abstract available.

    PubMed 35182761

Questions about this trial

What is this clinical trial studying?

A study testing SARS-CoV-2 screening by molecular biology and Serological screening in people with Covid19, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in Mali.

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 2 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mali. 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?

Incidence rate of positive SARS-Cov-2 RT-PCR in Bamako hospital departments during the study (time frame: Through the completion of subject participation (up to 15 months after study start date).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710316, which also lists 1 linked publication.

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 12 Dec 2025.

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