IRAK4 Inhibition in Treatment of COVID-19 With ARDS (I-RAMIC)

Subjects randomized to the PF-06650833 arm of the study will receive 200 mg IR suspension formulation every 6 hours (via nasogastric \[NG\] tube, orogastric \[OG\] tube, or equivalent) if unable to take tablets by mouth (PO). Subjects for whom concomitant administration of a strong inhibitor of cytochrome P450 (CYP) 3A4 will have the dose of the IR formulation to 200 mg once daily (QD). Subjects who can take tablets PO will receive 400 mg PF-06650833 (2-200 mg tablets) of the MR formulation QD under fasted conditions (preferably at least 4 hours after and 1.5 hours before a meal). No dose adjustment is needed for subjects taking the MR tablet preparation, except if co-administered with ritonavir in which case the dose should be reduced to 200 mg MR QD. All dosing of PF-06650833 will be in addition to current hospital SOC therapy.

Matching placebo tablets will be administered.