An investigator-led Phase III trial studying hydrocortisone for community-acquired pneumonia has been redesigned to also recruit COVID-19 patients, according to a source familiar with the trial. The France-based study has so far recruited about 300 COVID-19 patients and enrolment is estimated to close in two weeks, he added. As of today (7 April), France has 98,984 confirmed cases and 8,911 deaths.
The randomised, blinded Phase III CAPE COD trial (NCT02517489) does not have a specific enrolment target, allowing flexibility due to the unprecedented nature of the pandemic, the source said. The trial has futility checks in place, he noted, adding the aim is to release interim data as soon as possible. The study’s ClinicalTrials.gov listing, which was last updated June 2019, shows it has having a 1,200-patient target, and the first patient was recruited in October 2015.
While ClinicalTrials.gov states the study has an all-cause mortality primary endpoint measured at day 28, the source said this has been amended to become a composite primary endpoint to also include duration of stay in intensive care. The trial is recruiting patients in intensive care or intermediate care units. Although it is listed as having 32 sites, the source added it has expanded to 37.