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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InflaRx GmbH

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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