An interventional study of SARS-CoV-2 screening by molecular biology and Serological screening in Covid19, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 4 sites in Mali. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Screening
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.
Exclusion Criteria:
\- 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
Diagnostic Test: SARS-CoV-2 screening by molecular biology
Caregivers 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
Diagnostic Test: SARS-CoV-2 screening by molecular biology · Diagnostic Test: Serological screening
SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome
Serological screening of caregivers at D0, M1, M2, M3 (anti-nucleocapsid antibodies).
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.
Time frame: Through the completion of subject participation (up to 15 months after study start date).
Number of Cepheid Xpert® Xpress SARS-Cov-2 cartridges available for 19.8 USD/number required for the project
Time frame: Through the completion of subject participation (up to 15 months after study start date).
Percentage of positive serological tests among the caregivers of the hospital departments of Bamako.
Time frame: Assessed on the fourth serological assay performed (at Month 3).
Percentage of caregivers asymptomatic but immunized to SARS-CoV-2
Time frame: Assessed on the fourth serological assay performed (at Month 3).
Percentage of caregivers immunized and re-infected with SARS-CoV-2
Time frame: Through the completion of caregiver participation (up to 15 months after study start date).
Number of SARS-CoV-2 mutations/variants detected during the study
Time frame: Through the completion of subject participation (up to 15 months after study start date).
Percentage of SARS-CoV-2 mutations/variants detected during the study
Time frame: Through the completion of subject participation (up to 15 months after study start date).
Plan to share: No
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Institut National de la Santé Et de la Recherche Médicale, France