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Completed

NCT Number: NCT04710316

Study of COVID-19 Outbreak in Hospital Departments of 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Gabriel Toure, Bamako, Mali

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SARS-CoV-2 screening by molecular biology

Diagnostic Test

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

Serological screening

Diagnostic Test

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

Primary outcomes

  1. Incidence rate of positive SARS-Cov-2 RT-PCR in Bamako hospital departments during the study

    Time frame: 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 outcomes

  1. 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).

  2. 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).

  3. Percentage of caregivers asymptomatic but immunized to SARS-CoV-2

    Time frame: Assessed on the fourth serological assay performed (at Month 3).

  4. 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).

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: BAMACOV

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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