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

Covid19 Clinical Trial

— BAMACOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04710316
• Other study ID #: C20-41
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2020
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Almoustapha Issiaka MAIGA
• Phone: +223 76229920
• Email: amaiga[@]icermali.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• SARS-CoV-2 screening by molecular biology
SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome
• Serological screening
Serological screening of caregivers at D0, M1, M2, M3 (anti-nucleocapsid antibodies).

Locations

Country	Name	City	State
Mali	Hôpital dermatologique de Bamako	Bamako
Mali	Hôpital du Mali	Bamako
Mali	Hopital du Point-G	Bamako
Mali	Hopital Gabriel Toure	Bamako

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	Percentage of positive serological tests among the caregivers of the hospital departments of Bamako.		Assessed on the fourth serological assay performed (at Month 3).
Secondary	Percentage of caregivers asymptomatic but immunized to SARS-CoV-2		Assessed on the fourth serological assay performed (at Month 3).
Secondary	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).
Secondary	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).
Secondary	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).