Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

InflaRx GmbH

Conditions:

Severe COVID-19 Pneumonia

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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 par...

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.

Eligibility Criteria

Inclusion

  • Phase II
  • At least 18 years of age or older
  • Clinically evident or otherwise confirmed severe pneumonia
  • SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)

Exclusion

  • Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for \> 2 months
  • Patient moribund or expected to die in next 24h according to the judgment of the investigator
  • Known severe congestive heart failure (New York Heart Association \[NYHA\] Class III- IV)
  • Received organ or bone marrow transplantation in past 3 months
  • Known cardio-pulmonary mechanical resuscitation in past 14 days
  • Phase III:
  • Inclusion Criteria:
  • At least 18 years of age or older
  • Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP administration)
  • Patients with a PaO2 / FiO2 ratio of \< 200 and \> 60 at randomization (one representative measurement within 6h before randomization)
  • SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)

Key Trial Info

Start Date :

March 31 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2021

Estimated Enrollment :

399 Patients enrolled

Trial Details

Trial ID

NCT04333420

Start Date

March 31 2020

End Date

December 1 2021

Last Update

June 5 2023

Active Locations (48)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 12 (48 locations)

1

InflaRx Site #1107

Aalst, Belgium

2

InflaRx Site #1102

Brussels, Belgium

3

InflaRx Site #1104

Leuven, Belgium

4

InflaRx Site #1106

Lodelinsart, Belgium