A Telehealth-Based Randomized Controlled Trial: A Model for Outpatient Trials of Off-Label Medications During the COVID-19 Pandemic

In response to the COVID-19 pandemic, many clinical trials have been initiated but few are focused on outpatient drugs. Although there is a need to test off-label medications in the outpatient setting, recruitment is challenging because the desire to limit transmission of infection in clinic and hospital facilities has led to the establishment of virtual care and drive-through testing, restricting in-person access to potential trial participants. These challenges may partially account for why only a limited number of outpatient treatments have been evaluated during the pandemic.