NCT05411575撤回2 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 14
- 主要终点
- To demonstrate that Plerixafor is able to reduce the need for invasive mechanical ventilation or death in severe COVID-19 patients admitted in Intensive Care Unit (ICU)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age,
- •Using contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Willing and able to provide written informed consent (or provided by legally acceptable representative if he/she is present and if in line with local regulations),
- •Admitted in ICU within 48 hours before randomization for COVID-19 related respiratory failure. (ICU or equivalent medical structure according to country specificities e.g., Acute Respiratory Care Unit, High Dependency Care Unit if they can provide: continuous IV infusion,continuous ECG, respiratory rate, percutaneous oxygen saturation screen monitoring, high flow nasal oxygen)
- •Not requiring immediate (within 24-36 hours) invasive mechanical ventilation according to investigator's judgment,
- •Confirmed pneumoniae due to SARS-CoV-2, Laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR (in nasopharynx or throat samples) or other commercial or public health assay in any specimen, performed within 2 weeks prior to randomization,
- •Acute respiratory failure requiring oxygen support (≥ 5L/min) to achieve a transcutaneous oxygen saturation > 94%,
- •Estimated glomerular filtration rate (eGFR) > 50 mL/min/1.73m2 by the CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) equation.
排除标准
- •Pregnancy or breast feeding,
- •Anticipated transfer to another hospital, which is not a study site within 72 hours of randomisation,
- •Need for Invasive mechanical ventilation at time of inclusion,
- •Evidence of uncontrolled bacterial pneumopathy or active infection other than SARS-Cov-2 (laboratory confirmation),
- •Primitive pulmonary arterial hypertension,
- •Cardio-vascular co-morbidity:
- •History of vascular ischemic events (myocardial infarction or stroke) or congestive heart failure or peripheral arterial disease,
- •History or current significant cardiac rhythm disorders (e.g., ventricular tachycardia),
- •Known medical history of proven symptomatic postural hypotension,
- •Known cancer (solid or blood) in the last 5 previous years or previous haematological disorders (malignancies and other chronic conditions) or having received bone marrow transplant,
- •Inadequate haematological function defined by:
- •Neutrophil count < 1.0 x 109/L,
- •Haemoglobin < 9.0 g/dL (90 g/L),
- •Platelets < 100 x 109/L,
- •Kaliemia < 3.5 mmol/L and/or total Calcemia < 2.2 mmol/L,
- •Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) > 3 x upper limit of normal (ULN) and/or Total bilirubin > 2 x ULN,
- •Patients with known allergy to Plerixafor or its excipients.
- •Previous (within 4 weeks) or current participation in another clinical study other than an observational study.
- •Patients with auto immune disease treated or not,
研究组 & 干预措施
Placebo
Placebo Comparator
continuous intravenous infusion for 7 days of Placebo
干预措施: Placebo (Other)
Plerixafor
Experimental
Plerixafor (Mozobil®) continuous intravenous infusion for 7 days
干预措施: Plerixafor 20 MG/ML [Mozobil] (Drug)
结局指标
主要结局
To demonstrate that Plerixafor is able to reduce the need for invasive mechanical ventilation or death in severe COVID-19 patients admitted in Intensive Care Unit (ICU)
时间窗: Day 1- Day 28
Proportion of patients with need for invasive mechanical ventilation or death between randomization and D28
次要结局
- To evaluate the efficacy of Plerixafor compared to placebo on Level of consciousness(Day 1-Day 8, Day 14, Day 28, Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D28(Day 1-Day 28)
- To evaluate the efficacy of Plerixafor compared to placebo on Ventilator-free days between randomization and D28(Day 1-Day 28)
- To evaluate the efficacy of Plerixafor compared to placebo on Duration of mechanical ventilation between randomization and D90(Day 1-Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on Length of ICU stay between randomization and D90(Day 1-Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on SpO2 status(Day 1-Day 8, Day 14, Day 28, Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on Safety/Lab tests(up to Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on Respiratory/oxygenation status(Day 1-Day 8, Day 14, Day 28, Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on CRP, fibrinogen and D-dimers levels(Day 1, Day 3, Day 8, Day 14, Day 28)
- To evaluate the efficacy of Plerixafor compared to placebo on Safety AEs(up to Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on Mortality between randomization and D90(Day 1-Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on Respiratory function including FEV1, FVC, PaO2 and Transfer Lung Capacity for carbon monoxide (TLCO), 6-minute walk test(Day 1-Day 90)
- To evaluate the efficacy of Plerixafor compared to placebo on Clinical improvement(Day 1, Day 8, Day 14 Day 28, Day 90)
研究者
研究点 (14)
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