Adverse effects of COVID-19 pandemic on a multicenter randomized controlled trial.

ABSTRACT

OBJECTIVE: Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial. STUDY DESIGN: We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery. RESULT: The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic epoch and has not recovered to baseline even in the just-completed post-pandemic epoch (84.9%). Despite the decrease in subjects approached, there was no significant change in the overall consent rate for the study CONCLUSION: The pandemic has significantly limited ability to approach parents of eligible infants for consent, with only partial recovery. Opportunities for interactions of investigators and study coordinators with parents continue to present challenges limiting full recovery.