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

Institut National de la Santé Et de la Recherche Médicale, France

Status: Completed

Conditions: Covid19

Treatments: Diagnostic Test: SARS-CoV-2 screening by molecular biology; Diagnostic Test: Serological screening

Study type: Interventional

Funder types: Other

Identifiers

NCT04710316

C20-41

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Patients

Experimental group

Description:

\- 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

Treatment:

Diagnostic Test: SARS-CoV-2 screening by molecular biology

Caregivers

Experimental group

Description:

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

Treatment:

Diagnostic Test: Serological screening

Diagnostic Test: SARS-CoV-2 screening by molecular biology