A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-4)

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone
and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are
discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For
discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain
safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary
research as well as clinical outcome data. However, if infection control or other
restrictions limit the ability of the subject to return to the clinic, these visits may be
conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have
laboratory tests or collection of samples and is conducted by phone. The primary objective is
to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone +
remdesivir as assessed by the mechanical ventilation free survival by Day 29.