clinical trial · NCT04333420
Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
Severe COVID-19 PneumoniaIFX-1 + BSCBSCIFX-1 + SOCPlacebo + SOC
brief 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)
started
Mar 31, 2020
primary completion
Oct 31, 2021
completion
Dec 1, 2021
last updated
Jun 5, 2023
detailed description
The phase II and Phase III portions enrolled patients subsequently.
1st patient was enrolled in the phase III portion on 1st October 2020.
official title
A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol