Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)

Summary

This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age, * with acute respiratory failure related to COVID-19 and * Recently admitted in ICU or equivalent structure (within 48 hours) for COVID-19 related respiratory failure * without invasive mechanical ventilation and * requiring oxygen support ≥ 5L/min to obtain a transcutaneous O2 saturation \> 94% A total of 150 participants, will be randomized in a 2:1 ratio to receive either Plerixafor (n=100) or placebo (n=50) as a continuous IV infusion for 7 days (from D1 to D8) in addition to standard of care (e.g. glucocorticoids...). Safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) during the study.

Timeline

Start

2022-07-19

Primary completion

2022-10

Completion

2022-10

Drugs

Indications