Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Phase II & Phase III:
This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1
for the treatment of COVID-19 related severe pneumonia. The study consists of two parts:
Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) +
IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled,
randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC +
placebo-to-match (Arm B)