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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 450 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\- 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
Ran from Feb 2021 to primary completion in Apr 2022, 14 months.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 14 months is above that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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