Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.