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

项目摘要/摘要 计划中的新冠肺炎疫苗试验需要筛选、登记和跟踪超过150,000名志愿者研究 参与者超过24个月。试验参与者将根据他们感染新冠肺炎的风险进行选择， 由于试验参与者来自社区传播率较高的环境，患病风险较高的群体 进展为症状性疾病，或两者兼而有之。从事新冠肺炎疫苗试验的研究人员将需要 在定期访问期间与试验参与者互动，并对所有疫苗进行面对面评估 试验参与者的症状可能是由于新冠肺炎病。这将导致近距离接触 研究人员与高危参与者或受感染参与者之间的关系。因此，研究人员需要访问 定期供应个人防护装备，包括外科口罩、面罩或护目镜； 睡袍和一次性手套，以及经常洗手的能力。个人防护装备的这种组合将 在与研究参与者的所有有风险的互动中使用，例如在采集鼻拭子和在 评估参与者可能的研究终点，包括症状性新冠肺炎病。此外, 所有医护人员在正常工作时间和整个工作日都需要佩戴外科口罩。 为流动研究卫星站点设置或现场设置。如果没有适当的个人防护装备，医护人员很容易受到伤害。 感染新冠肺炎，以及被动传播给与他们有密切身体接触的人 联系。获得足够的个人防护用品是安全有效进行新冠肺炎的关键组成部分 疫苗试验，并将能够准确确定研究终点，特别是有症状的COVID- 19种疾病。

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.