High-Frequency, At-Home Monitoring of Drug Safety and Tolerability in Clinical Trials: Results From Studies of Fluvoxamine for COVID-19 Treatment.

Clinical trials are increasingly using remote monitoring techniques at the patient's home. We conducted a secondary analysis of remote safety and tolerability monitoring from two fully-remote clinical trials that tested fluvoxamine for the acute treatment of COVID-19. Both trials assessed pulse and blood pressure daily, and one study assessed symptoms daily via Ecological Momentary Assessment. On average, patients provided data on vital signs on 93% of the study days and provided data on side effects on 81% of the study days. With respect to safety, patients taking fluvoxamine had reduced pulse rate compared to placebo, with the greatest difference-5 points-at treatment Day 4. In contrast, fluvoxamine showed little to no effect on blood pressure. With respect to tolerability, nausea was most frequent in the first 4-5 days, declining significantly thereafter, while anxiety and difficulty concentrating were uncommon with fluvoxamine compared to placebo. These findings show that remote assessment of safety and tolerability is feasible in clinical trials, and that frequent assessments can provide in-depth data on the timecourse of safety or tolerability signals.