Conducting a VR Clinical Trial in the Era of COVID-19.

The outbreak of severe acute respiratory syndrome coronavirus 2, also known as Coronavirus Disease 2019 (COVID-19) sparked a global public health pandemic that has impacted every aspect of daily life. Medical research was affected, and many clinical trials were halted to minimize COVID-19 transmission risk and spread while the world navigated this novel virus. Here we describe the relaunch of our virtual reality (VR) pilot clinical trial that uses an in-lab brain and body training program to promote brain health in mid-to-late life older adults, in the era of COVID-19. This case series includes five healthy female participants between 51 and 76 years of age, a subset of a larger VR pilot clinical trial that started pre-pandemic. We developed a revised study protocol based on the Center for Disease Control and World Health Organization guidelines to help manage the spread of COVID-19. Since the limited resumption of clinical trials at our institution in August 2020, we successfully completed over 200 in-lab virtual reality training sessions using our revised protocol. During this time, none of the five participants or three study staff reported any COVID-19 symptoms or reported a positive COVID-19 test. More than 40 voluntary COVID-19 tests were completed by our study staff over the last 6 months. All participants rated our safety protocol as very satisfied or extremely satisfied and that they would be very likely or extremely likely to participate in a VR clinical trial during the pandemic. Based on these findings, we suggest that continued VR clinical trial research during the COVID-19 pandemic is achievable and can be safely resumed if specific safety protocols are in place to mitigate the risk of exposure and spread of COVID-19.