Impact of the Coronavirus Disease 2019 pandemic on an ongoing pragmatic pediatric clinical trial

Abstract

Background: The coronavirus disease 2019 (COVID-19) pandemic has a significant negative impact on clinical trials. Therefore, maintaining an optimal trial conduct should be considered to minimize risks to trial integrity while ensuring the safety of trial staff and participants. In this study, we aimed to describe the impact of the COVID-19 pandemic on conducting an ongoing clinical trial, along with challenges and solutions encountered and required to continue the trial. Methods: This Phase IV pragmatic randomized superiority controlled open-label trial included children with epilepsy receiving Vitamin D supplementation at King Saud University Medical City, Riyadh, Saudi Arabia (clinicaltrials.gov registration number: NCT03536845). Children with epilepsy receiving chronic antiepileptic medications and with normal baseline 25-hydroxyvitamin D level were randomized to receive cholecalciferol 400 IU/day versus 1000 IU/day for 6 months. The primary outcome was the percentage of children with Vitamin D insufficiency at 6 months. The secondary outcomes included seizure control, bone mineral density, and safety. Results: Under COVID-19 public health emergency measures, exceptional methods were used, such as telemedicine, home visit for blood extractions, shipping of the study medication to the patient's home, using reminder text messages to follow patients' compliance, and using privacy-compliant platforms to connect the research team members. Conclusion: During the widespread pandemic, ethical dilemmas are of major concern, especially when conducting trials on vulnerable age groups. Therefore, actions should be proportionate and based on benefit-risk considerations, affecting the risk of bias from protocol deviation and overall results.

Keywords

• children
• clinical trial
• coronavirus disease 2019
• covid-19
• epilepsy
• pandemic
• vitamin d