Extended-duration dexamethasone for the treatment of hospitalized COVID-19 patients in Canada: A randomized clinical trial

The optimal duration of corticosteroid therapy in hospitalized COVID-19 patients remains uncertain. While a 10-day course of dexamethasone reduces mortality, the benefit of extending treatment in patients who continue to require oxygen is unknown. This open-label randomized trial was conducted as part of the Canadian Treatments for COVID-19 (CATCO) trial, the Canadian arm of the WHO Solidarity trial. Between January 19 and October 4, 2022, hospitalized COVID-19 patients who had completed 10 days of dexamethasone and remained on supplemental oxygen were randomized to receive either extended dexamethasone treatment or standard care. The primary outcome was the WHO ordinal scale at day 28. Secondary outcomes included in-hospital and 90-day mortality, oxygen and ventilation requirements, and hospital length of stay. Eleven patients were enrolled across five Canadian sites before early termination due to declining admissions. Median WHO scores at day 28 were similar between groups. One patient in the standard care group required new oxygen therapy; no patients required mechanical ventilation. One patient in the extended group died during hospitalization; by day 90, two had died in the extended group and none in the standard care group. In this small randomized controlled trial, we cannot determine effectiveness of extended dexamethasone for hospitalized patients with COVID-19 who require oxygen after 10 days of therapy. Larger, adequately powered trials are needed.