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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04710316
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: SARS-CoV-2 screening by molecular biology Diagnostic Test: Serological screening Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Étude de l'épidémie de SARS-CoV-2 Dans Les Services Hospitaliers de Bamako, Mali
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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). ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710316


Contacts
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Contact: Almoustapha Issiaka MAIGA +223 76229920 amaiga@icermali.org

Locations
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Mali
Hopital du Point-G Not yet recruiting
Bamako, Mali
Contact: Yacouba Toloba    +223 76 39 02 23      
Hopital Gabriel Toure Recruiting
Bamako, Mali
Contact: Mahamadou Saliou    +223 76 33 34 24      
Hôpital dermatologique de Bamako Recruiting
Bamako, Mali
Contact: Abdoulaye TRAORE    +223 73 00 32 32      
Hôpital du Mali Recruiting
Bamako, Mali
Contact: Gara DABO    +223 73 93 88 43      
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Almoustapha Issiaka MAIGA SEREFO/UCRC, FMOS - University Hospital Gabriel Toure, Bamako, Mali
Principal Investigator: Eve Todesco APHP - Sorbonne university
More Information
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04710316    
Other Study ID Numbers: C20-41
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Covid-19
SARS-CoV-2
Mali
Africa
Hospital
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases