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最高研发阶段批准上市 |
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首次获批日期2008-12-15 |
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.
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.
100 项与 4Living Biotech 相关的临床结果
0 项与 4Living Biotech 相关的专利(医药)
100 项与 4Living Biotech 相关的药物交易
100 项与 4Living Biotech 相关的转化医学