Covid19
Conditions
Keywords
Covid-19, SARS-CoV-2, Mali, Africa, Hospital
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTSARS-CoV-2 screening by molecular biology
SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome
DIAGNOSTIC_TESTSerological screening
Serological screening of caregivers at D0, M1, M2, M3 (anti-nucleocapsid antibodies).
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Persons subject to legal protection or not able to give a free and informed consent. * Caregivers: caregivers not able to follow the project schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of positive SARS-Cov-2 RT-PCR in Bamako hospital departments during the study | Through the completion of subject participation (up to 15 months after study start date). | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of positive serological tests among the caregivers of the hospital departments of Bamako. | Assessed on the fourth serological assay performed (at Month 3). |
| Percentage of caregivers asymptomatic but immunized to SARS-CoV-2 | Assessed on the fourth serological assay performed (at Month 3). |
| Number of Cepheid Xpert® Xpress SARS-Cov-2 cartridges available for 19.8 USD/number required for the project | Through the completion of subject participation (up to 15 months after study start date). |
| Number of SARS-CoV-2 mutations/variants detected during the study | 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 | Through the completion of subject participation (up to 15 months after study start date). |
| Percentage of caregivers immunized and re-infected with SARS-CoV-2 | Through the completion of caregiver participation (up to 15 months after study start date). |
Countries
Mali
Outcome results
None listed