Patient perspective of participation in COVID-19 clinical trials

Introduction: The STOIC trial investigated inhaled budesonide as a treatment for early symptomatic COVID-19. It involved home visits, symptom diary completion and daily phone calls for 28 days. There are approximately 4750 patient studies on COVID-19, but little is known on patient perspectives on participation. Objectives: Participants views on participation on this novel study design were sought. Methods: Anonymous feedback forms were handed to participants at their final visit. The form consisted of five qualitative and four Likert scale questions. The qualitative responses were coded by hand and separated into themes: participant experience, willingness to participate in studies and study barriers. Results: Of the 139 participants, mean age 45 years (19 to 79), who completed study, 74 participants completed feedback forms. The frequent phone calls and study visits were found to be not troublesome; 91.89% (N=68) and 89.19% (N=66), respectively (Figure 1). The daily phone calls and weekly study visits felt to be reassuring by 89.19% (N=66). Oximeter malfunction was the main barrier reported. Participants reported high satisfaction regardless of study drug allocation. This model would be recommended to friends and family by 89.19% (N=66). Conclusion: During the COVID-19 pandemic in the United Kingdom, primary care study participants found easy access to trial staff reassuring. Remote monitoring of physiology and symptoms was valued by participants.