A large biotech company contracted Accellacare to drive recruitment in a clinical trial to test the safety and efficacy of a treatment for ambulatory patients with COVID-19.

The Accellacare site in Wilmington, NC was selected for the study in August of 2020 with an initial goal of enrolling 5 patients per week for a total of 20 patients. At the time, the enrollment target seemed ambitious, as the COVID-19 cases in Wilmington were low, but cases started to spike in Q4 2020 and the site started receiving more referrals than could be enrolled. The visit schedule, as outlined in the protocol, quickly became demanding, as patients needed to be seen every 2 days for the first 2 weeks, including weekends and holidays.

Due to the high operational demand, managing resourcing and staff welfare was a challenge. Additionally, the team had to consider the right approach to treat a high volume of COVID-positive patients at the site without risking the safety of staff and patients. The site staff recognised that the study had the potential to greatly impact the local community and wanted to include as many qualified patients as possible.

Initially, the study team consisted of 3 full-time staff and took up half of a stand-alone building to keep the highly infectious patient group separate from other patients and staff. The team was able to anticipate the spike at peak enrollment from December 2020-January 2021 and was able to expand the team to 10 experienced clinical research professionals solely focused on this study. The team included study coordinators, coordinator assistants, a dedicated laboratory coordinator, registered nurses led by a senior clinical research manager. During the height of enrollment, the study staff not only saw patients and kept close follow-up, but used an “all hands on deck” approach to answer queries and troubleshoot diary issues with patients, manage database locks, and build lab kits from scratch due to the global demand on central laboratories.

To keep up with the changing environment, daily team meetings were scheduled to share updates, discuss evolving challenges and collaborate on ways to optimise study processes to protect patients and reduce increasing staff burden.

The site’s Principal Investigator, Dr Cannon, provided the critical medical oversight and his leadership and motivation encouraged the teamwork that was essential to meet the demands of a study during the pandemic.

The study team needed to be vigilant and agile, constantly reviewing and refining processes and preparing for engagement with more patients. As the volume of patients throughput increased, facilities had to be reassessed and operations were expanded to the entire stand-alone building, adding three temporary outdoor tents at the peak of activity to increase capacity for treatment areas.

By identifying the challenges, developing innovative solutions and adapting quickly to unprecedented difficult conditions, the Accellacare team deployed an operational strategy that removed the barriers and ensured efficient, safe and quality driven delivery.

The team enrolled over 560 patients - a patient population that far exceeded the initial enrollment goal set by the sponsor. The team’s agility in adapting to evolving conditions enabled the scaling of site operations from being able to treat only 1-2 patients a day, to treating 4 patients simultaneously, and up to 55 visits per day at the peak of the crisis.