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

用于 COVID-19 相关疫苗和治疗临床试验和临床研究资源的个人防护装备

• 批准号: 10252679
• 负责人: Lawrence Corey
• 金额: $ 2136.07万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-11-05 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10252679
• 关键词: COVID-19; COVID-19 vaccine; Clinical Research; Clinical Treatment; Clinical Trials; Collection; Communities; Disease; Enrollment; Evaluation; Face; Goggles; Hand; Health Personnel; Infection; Participant; Persons; Resources; Risk; SARS-CoV-2 infection; Site; Symptoms; Vaccines; Visit; base; health care settings; high risk; nasal swab; personal protective equipment; screening; surgical mask; symptomatic COVID-19; transmission process; vaccine trial; volunteer

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.

项目概要/摘要 计划中的 COVID-19 疫苗试验需要筛选、招募和跟踪超过 150,000 名志愿者研究 超过 24 个月的参与者。将根据感染 COVID-19 的风险来选择试验参与者， 由于试验参与者来自社区传播率高的地区，因此感染风险较高的群体 进展为有症状的疾病，或两者兼而有之。从事 COVID-19 疫苗试验的研究人员需要 在定期访问期间与试验参与者互动并对所有疫苗进行现场评估 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 研究人员和高风险参与者或受感染的参与者之间。因此，研究人员需要访问 定期供应个人防护装备 (PPE)，包括外科口罩、面罩或护目镜， 长袍和一次性手套，以及经常消毒双手的能力。这种个人防护装备的组合将 在与研究参与者的所有危险互动期间使用，例如在鼻拭子收集期间和在 评估参与者可能的研究终点，包括有症状的 COVID-19 疾病。此外， 所有工作人员在医疗机构的正常工作日期间和整个工作日都需要佩戴外科口罩 设置或现场移动研究卫星站点。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 COVID-19，以及被动传播给与其密切接触的人 接触。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，特别是有症状的新冠肺炎 19种疾病。