Calyx IRT was the system of choice for a study involving patients admitted in intensive care units (ICU) due to complications linked to COVID-19 infection. The study was run through a CRO, and Calyx worked directly with both the CRO and the sponsor team.
On paper, the study was a relatively simple IRT design, investigating whether the study drug would reduce the time spent in ICU. Patients were enrolled in the study upon admission, treated in the ICU, and dosed up to 6 times over the course of 28 days or until discharge, whichever was earliest. There was an established depot network from the study start and supplies to sites were based on expected recruitment rates.
However, clinical trials rarely go to plan, do they?!