CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 399 enrolled
Drug / intervention
IFX-1 + BSC +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04333420
NCT04333420Phase 3Completed
CompareCT.gov

A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

InflaRx GmbH·interventional·Posted Apr 3, 2020·Updated Jun 5, 2023

In Brief

A Phase 3 clinical trial evaluating IFX-1 + BSC, BSC, and 2 other interventions for Severe COVID-19 Pneumonia. Completed, enrolled 399 participants across 48 sites in 9 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere COVID-19 Pneumonia
CountriesBelgium, Brazil, France, Germany, Mexico, Netherlands, Peru, Russia, South Africa
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 3, 2020
Enrollment StartMar 31, 2020
Primary CompletionOct 31, 2021
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.2 years ago

Interventions

IFX-1 + BSCdrug

Phase II study part: IFX-1 + BSC

BSCdrug

Phase II study part: BSC

IFX-1 + SOCdrug

Phase III study part: IFX-1 + SOC

Placebo + SOCdrug

Phase III study part: Placebo + SOC