ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir
alone. 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 and oropharyngeal (OP) swab and blood (serum only) samples for secondary
research as well as clinical outcome data. However, infection control or other restrictions
may limit the ability of the subject to return to the clinic. In this case, 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 outcome
is time to recovery by Day 29.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)