NCT04333420

Randomized, Controlled Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: InflaRx GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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.

Conditions

• Severe COVID-19 Pneumonia

Interventions

Type	Name	Description
DRUG	IFX-1 + BSC	Phase II study part: IFX-1 + BSC
DRUG	BSC	Phase II study part: BSC
DRUG	IFX-1 + SOC	Phase III study part: IFX-1 + SOC
DRUG	Placebo + SOC	Phase III study part: Placebo + SOC

Timeline

• Start date: 2020-03-31
• Primary completion: 2021-10-31
• Completion: 2021-12-01
• First posted: 2020-04-03
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

48 sites across 9 countries: Belgium, Brazil, France, Germany, Mexico, Netherlands, Peru, Russia, South Africa

Regulatory

• FDA-regulated drug study