MedTrace Logo

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

NCT04333420 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2023-06-05

Study results available
· View outcomes & findings →

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)

Conditions

  • Severe COVID-19 Pneumonia

Interventions

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

Sponsors & Collaborators

  • InflaRx GmbH

    lead INDUSTRY

Principal Investigators

  • A Vlaar, MD, PhD · University Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-31
Primary Completion
2021-10-31
Completion
2021-12-01
FDA Drug
Yes

Countries

  • Belgium
  • Brazil
  • France
  • Germany
  • Mexico
  • Netherlands
  • Peru
  • Russia
  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333420 on ClinicalTrials.gov