A large pharma sponsor was conducting two treatment studies in patients with COVID-19 with the goal to enroll several hundred patients in each study. ICON’s Accellacare In-Home Services were used across more than 50 sites in the United States to conduct blood draws and nasal swabs, collect vital signs, and monitor for changes in health, medications, or hospitalisation. An agile, coordinated approach ensured the sponsor was able to meet and exceed enrollment goals while ensuring the safety of patients and study staff.

A large pharma organisation was looking to enroll 500 patients and 250 patients in two COVID-19 treatment studies, respectively. The sponsor worked with more than 50 US sites to identify and recruit patients who tested positive for COVID-19 in a safe and time-efficient manner. Concerns about site contamination and potential infection of staff and patients led the sponsor to contract Accellacare In-Home Services to conduct trial visits in patients’ homes.

In addition to the common logistical challenges of running a trial during a pandemic, the two studies took on added exposure risk as site and study staff were working directly with COVID-19 positive patients. Global personal protective equipment (PPE) and study supply shortages were a concern, as the central lab struggled to keep up with tests for supply kits.

A rapid timeline also posed a significant challenge. Once identified and randomised into the trials, patient visits needed to occur within 48 hours compared to the average turnaround time of five to seven business days. Sites needed support scheduling nurses and ensuring all study supplies were distributed in a timely manner to ensure patients were still COVID-positive and treatment wasadministered at the correct time. Additionally, as the pandemic continued to spread, sites saw a rapid increase in patient volume, furthering the demand for PPE, study supplies, and in-home visit scheduling.

An agile approach was essential to ensuring the sponsor’s enrollment targets could be achieved safely and efficiently. Accellacare In-Home Services implemented an FTE model with dedicated nurses to meet the high patient volume and timing demands. Designated nurses for each site location and region were trained and equipped with supply kits so that they were ready to conduct in-home visits as soon as a new patient was identified, ensuring the quick 48- hour turnaround timeline of both studies.

Accellacare also developed an all-hands-on-deck, coordinated approach for supply provision and distribution, working closely with sites to address any supply shortages when demand could not be met by the central lab and providing head-to-toe PPE for all nurses going into patient homes.

Despite logistical and safety challenges, the sponsor was able to meet and exceed their enrollment goals by more than double. Leveraging Accellacare In-Home Services, the sponsor was able to conduct the first patient visit within two weeks of the signed work order. Additionally, more than 95% of visits were conducted within the short, 48-hour protocol window, with more than 9,800 home visits completed over the course of both studies.