A Cluster Randomized Trial of Two Mask Systems (Acteev™ N95 + Acteev™ Fabric Masks vs. Standard N95 + Fabric Masks During Shifts & in Community) in Preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) in HCWs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,600
- 试验地点
- 2
- 主要终点
- The efficacy of Acteev™ system vs standard system in preventing SARS CoV-2 infection in health care workers
研究概览
简要总结
A cluster randomized trial will be conducted to evaluate the difference between an Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) and a standard system (standard N95 masks during shifts+ fabric masks in community) in preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2)in healthcare workers(HCWs).
详细描述
This is a maximum 10-week (8-week intervention+2-week follow up) two-armed controlled study to investigate efficacy of Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) compared with standard system (standard N95 masks during shifts+ fabric masks in community) in HCWs working in high-risk hospital wards (ICU, emergency), against the prevention of SARS CoV-2 infection. Prospective HCWs will be identified for the study by the study investigator/study team and be invited for participation in the study. All study procedures will begin only after obtaining written informed consent from the subjects. Subjects will be randomized in one of the two arms mentioned below after meeting all the study eligibility criteria: Arm 1:Acteev™ system (Acteev™ N95 masks YQD8008 during shifts+ Acteev™ fabric masks in community) Arm 2: Standard system (standard N95 masks during shifts+ fabric masks in community).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Health care workers and allied health care staff working in COVID wards, COVID ICU, Non COVID ICU (This will include all specialty ICUs in the hospital), Casualty/Emergency, Operation Theatre and Pathology lab of the hospital
- •Health care workers and allied health care staff involved in performing high risk procedures like suctioning, intubation, nebulized medications, chest physiotherapy, other aerosol generating procedures and handling pathology samples
- •Negative COVID 19 RT-PCR test within last 3 days of screening
- •COVID 19 vaccinated or non-vaccinated
排除标准
- •Unable or refused to consent
- •Current respiratory illness, rhinitis and/or allergy
- •Currently participating in any other clinical trial
- •Beard or facial hair
结局指标
主要结局
The efficacy of Acteev™ system vs standard system in preventing SARS CoV-2 infection in health care workers
时间窗: 8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up.
• Number of cases with laboratory-confirmed for viral SARS CoV 2 respiratory infection using RT-PCR with or without two or more respiratory symptoms or one respiratory symptom and/or a systemic symptom
次要结局
- The efficacy of Acteev™ system vs standard system in preventing CRI/ILI infection in healthcare workers(8 weeks of wearing the masks (with the option of increasing to 12 weeks) with 2 weeks of following up)