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

Project Summary/Abstract: Planned COVID-19 vaccine trials require screening, enrolling, and following over 150,000 volunteer studyparticipants 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 ofprogression to symptomatic disease, or both. Study staff working on COVID-19 vaccine trials will need tointeract with trial participants during regular visits as well as conducting in-person assessments of all vaccinetrial participants with symptoms that could be due to COVID-19 disease. This will result in close contactbetween study staff and high-risk participants or infected participants. As a result, study staff need to access aregular 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 willbe used during all risky interactions with study participants, such as during nasal swab collection and duringevaluation 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 caresetting or on site for mobile study satellite sites. Without appropriate PPE, health care workers are vulnerableto infection with COVID-19, as well as passively transmitting to persons with whom they are in close physicalcontact. Access to adequate PPE is a critical component of the safe and effective conduct of COVID-19vaccine trials, and will enable accurate determination of the study endpoints, especially symptomatic COVID-19 disease.