Étude de l'épidémie de SARS-CoV-2 Dans Les Services Hospitaliers de Bamako, Mali
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 4
- 主要终点
- Incidence rate of positive SARS-Cov-2 RT-PCR in Bamako hospital departments during the study
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Persons subject to legal protection or not able to give a free and informed consent.
- •Caregivers: caregivers not able to follow the project schedule
结局指标
主要结局
Incidence rate of positive SARS-Cov-2 RT-PCR in Bamako hospital departments during the study
时间窗: 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.
次要结局
- 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).)
- 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 immunized and re-infected with SARS-CoV-2(Through the completion of caregiver participation (up to 15 months after study start date).)
- Percentage of caregivers asymptomatic but immunized to SARS-CoV-2(Assessed on the fourth serological assay performed (at Month 3).)