Personal Protective Equipment for Resources for COVID-19 Related Vaccine and Treatment Clinical Trials and Clinical Studies

项目总结/摘要 计划中的COVID-19疫苗试验需要筛选，招募和跟踪超过15万名志愿者研究 参与者超过24个月。将根据COVID-19感染的风险选择试验参与者， 由于试验参与者来自社区传播率高的环境， 进展为有症状的疾病，或两者兼有。从事COVID-19疫苗试验的研究人员需要 在定期访视期间与试验参与者互动，并对所有疫苗进行面对面评估 出现可能由COVID-19疾病引起的症状的试验参与者。这将导致密切接触 研究工作人员与高风险受试者或受感染受试者之间。因此，研究工作人员需要访问 定期提供个人防护设备，包括外科口罩、面罩或护目镜， 手术衣和一次性手套，以及经常消毒双手的能力。这种PPE组合将 在与研究受试者的所有风险交互期间使用，例如在鼻拭子采集期间和 评估参与者可能的研究终点，包括症状性COVID-19疾病。此外，本发明还提供了一种方法， 所有医护人员在日常工作期间及整个工作期间均须佩戴外科口罩， 设置或现场为移动的研究卫星站点。没有适当的个人防护装备，卫生保健工作者很容易受到伤害。 感染COVID-19，以及被动传播给与他们有密切身体接触的人 contact.获得足够的个人防护装备是安全有效地应对COVID-19的关键组成部分 疫苗试验，并将能够准确确定研究终点，特别是症状性COVID-1， 19疾病

Project Summary/Abstract Planned COVID-19 vaccine trials require screening, enrolling, and following over 150,000 volunteer study participants over 24 months. The trial participants will be selected based on their risk of COVID-19 infection, with trial participants coming from settings with high rates of community transmission, groups with higher risk of progression to symptomatic disease, or both. Study staff working on COVID-19 vaccine trials will need to interact with trial participants during regular visits as well as conducting in-person assessments of all vaccine trial participants with symptoms that could be due to COVID-19 disease. This will result in close contact between study staff and high-risk participants or infected participants. As a result, study staff need to access a regular supply of personal protective equipment (PPE), including surgical masks, face shields or goggles, gowns, and disposable gloves, as well as the ability to sanitize hands frequently. This combination of PPE will be used during all risky interactions with study participants, such as during nasal swab collection and during evaluation of participants for possible study endpoints, including symptomatic COVID-19 disease. In addition, all staff will need to wear surgical face masks during and throughout their normal workday in the health care setting or on site for mobile study satellite sites. Without appropriate PPE, health care workers are vulnerable to infection with COVID-19, as well as passively transmitting to persons with whom they are in close physical contact. Access to adequate PPE is a critical component of the safe and effective conduct of COVID-19 vaccine trials, and will enable accurate determination of the study endpoints, especially symptomatic COVID- 19 disease.