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

Primary Purpose

Covid19

Status
Unknown status
Phase
Not Applicable
Locations
Mali
Study Type
Interventional
Intervention
SARS-CoV-2 screening by molecular biology
Serological screening
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19 focused on measuring Covid-19, SARS-CoV-2, Mali, Africa, Hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital du Point-G
  • Hopital Gabriel ToureRecruiting
  • Hôpital dermatologique de BamakoRecruiting
  • Hôpital du MaliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

Caregivers

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Cepheid Xpert® Xpress SARS-Cov-2 cartridges available for 19.8 USD/number required for the project
Percentage of positive serological tests among the caregivers of the hospital departments of Bamako.
Percentage of caregivers asymptomatic but immunized to SARS-CoV-2
Percentage of caregivers immunized and re-infected with SARS-CoV-2
Number of SARS-CoV-2 mutations/variants detected during the study
Percentage of SARS-CoV-2 mutations/variants detected during the study

Full Information

First Posted
January 8, 2021
Last Updated
September 22, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04710316
Brief Title
Study of COVID-19 Outbreak in Hospital Departments of Bamako, Mali
Acronym
BAMACOV
Official Title
Étude de l'épidémie de SARS-CoV-2 Dans Les Services Hospitaliers de Bamako, Mali
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid-19, SARS-CoV-2, Mali, Africa, Hospital

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm 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
Arm Title
Caregivers
Arm Type
Experimental
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
SARS-CoV-2 screening by molecular biology
Intervention Description
SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome
Intervention Type
Diagnostic Test
Intervention Name(s)
Serological screening
Intervention Description
Serological screening of caregivers at D0, M1, M2, M3 (anti-nucleocapsid antibodies).
Primary Outcome Measure Information:
Title
Incidence rate of positive SARS-Cov-2 RT-PCR in Bamako hospital departments during the study
Description
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.
Time Frame
Through the completion of subject participation (up to 15 months after study start date).
Secondary Outcome Measure Information:
Title
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).
Title
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).
Title
Percentage of caregivers asymptomatic but immunized to SARS-CoV-2
Time Frame
Assessed on the fourth serological assay performed (at Month 3).
Title
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).
Title
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).
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Almoustapha Issiaka MAIGA
Phone
+223 76229920
Email
amaiga@icermali.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Almoustapha Issiaka MAIGA
Organizational Affiliation
SEREFO/UCRC, FMOS - University Hospital Gabriel Toure, Bamako, Mali
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eve Todesco
Organizational Affiliation
APHP - Sorbonne university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital du Point-G
City
Bamako
Country
Mali
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yacouba Toloba
Phone
+223 76 39 02 23
Facility Name
Hopital Gabriel Toure
City
Bamako
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahamadou Saliou
Phone
+223 76 33 34 24
Facility Name
Hôpital dermatologique de Bamako
City
Bamako
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdoulaye TRAORE
Phone
+223 73 00 32 32
Facility Name
Hôpital du Mali
City
Bamako
Country
Mali
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gara DABO
Phone
+223 73 93 88 43

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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