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

NCT ID: NCT04710316

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2022-09-30

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.

Conditions

Covid19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patients

\- 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

Group Type: EXPERIMENTAL

SARS-CoV-2 screening by molecular biology

Intervention Type: DIAGNOSTIC_TEST

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

Caregivers

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

Group Type: EXPERIMENTAL

SARS-CoV-2 screening by molecular biology

Intervention Type: DIAGNOSTIC_TEST

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

Serological screening

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

SARS-CoV-2 screening by molecular biology

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

Intervention Type: DIAGNOSTIC_TEST

Serological screening

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Almoustapha Issiaka MAIGA

Role: PRINCIPAL_INVESTIGATOR

SEREFO/UCRC, FMOS - University Hospital Gabriel Toure, Bamako, Mali

Eve Todesco

Role: PRINCIPAL_INVESTIGATOR

APHP - Sorbonne university

Locations

Hopital du Point-G

Bamako, , Mali

Hopital Gabriel Toure

Bamako, , Mali

Hôpital dermatologique de Bamako

Bamako, , Mali

Hôpital du Mali

Bamako, , Mali

Countries

Mali

References

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.

Reference Type: RESULT

PMID: 35182761 (View on PubMed)

Other Identifiers

C20-41

Identifier Type: -

Identifier Source: org_study_id