NCT05411575

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

A Randomized, Double-blind, Placebo-controlled, Two Parallel Groups, International Multicenter Trial to Evaluate the Effect of Plerixafor in Acute Respiratory Failure Related to COVID-19.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: 4Living Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Acute Respiratory Distress Syndrome
• COVID-19

Interventions

Type	Name	Description
DRUG	Plerixafor 20 MG/ML [Mozobil]	Plerixafor (Mozobil®) continuous intravenous infusion for 7 days
OTHER	Placebo	Placebo continuous intravenous infusion for 7 days

Timeline

• Start date: 2022-07-19
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2022-06-09
• Last updated: 2023-04-10

Locations

14 sites across 2 countries: Bulgaria, France