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

Étude de l'épidémie de SARS-CoV-2 Dans Les Services Hospitaliers de Bamako, Mali

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 screening by molecular biology; Diagnostic test: Serological screening

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali
    • Hopital Gabriel Toure
  • Bamako, Mali
    • Hôpital du Mali
  • Bamako, Mali
    • Hopital du Point-G
  • Bamako, Mali
    • Hôpital dermatologique de Bamako

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Diagnostic test: SARS-CoV-2 screening by molecular biology; SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome
Experimental: 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	Diagnostic test: SARS-CoV-2 screening by molecular biology; SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome; Diagnostic test: Serological screening; Serological screening of caregivers at D0, M1, M2, M3 (anti-nucleocapsid antibodies).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through the completion of subject participation (up to 15 months after study start date).

Secondary Outcome Measures

Outcome Measure	Time Frame
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Almoustapha Issiaka MAIGA, SEREFO/UCRC, FMOS - University Hospital Gabriel Toure, Bamako, Mali; Principal Investigator: Eve Todesco, APHP - Sorbonne university

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid-19; Hospital; Africa; Mali
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: C20-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No