EUCTR2021-001245-13-NL进行中（未招募）1 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 (LEONARDO) - LEONARDO
4Living Biotech SAS0 个研究点目标入组 150 人开始时间: 2022年1月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •I1 Male or female = 18 years of age,
- •I2 Using contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies,
- •I3 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),
- •I4 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
- •I5 Not requiring immediate (within 24-36 hours) invasive mechanical ventilation according to investigator's judgment,
- •I6 Confirmed pneumoniae due to SARS-CoV-2 with Laboratoryconfirmed 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,
- •I7 Acute respiratory failure requiring oxygen support (= 5L/min) to achieve a transcutaneous oxygen saturation > 94%,
- •I8 Estimated glomerular filtration rate (eGFR) > 50 mL/min/1.73m² by the CKD-EPI (Chronic Kidney Disease – Epidemiology Collaboration) equation.
- •Patients vaccinated against SARS-CoV-2 can be included in the study.
- •During the whole study, patients will receive standard of care for ethical reasons (e.g. glucocorticoids)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •E1 Pregnancy or breast feeding,
- •E2 Anticipated transfer to another hospital, which is not a study site within 72 hours of randomisation,
- •E3 Need for Invasive mechanical ventilation at time of inclusion,
- •E4 Evidence of uncontrolled bacterial pneumopathy or active infection other than SARS-Cov-2 (laboratory confirmation),
- •E5 Primitive pulmonary arterial hypertension,
- •E6 Cardio-vascular co-morbidity:
- •o History of vascular ischemic events (myocardial infarction or stroke) or congestive heart failure or peripheral arterial disease,
- •o History or current significant cardiac rhythm disorders (e.g., ventricular tachycardia),
- •o Known medical history of proven symptomatic postural hypotension,
- •E7 Evolutive cancer including acute and chronic leukaemia,
- •E8 Inadequate haematological function defined by:
- •o Neutrophil count < 1.0 x 109/L,
- •o Haemoglobin < 9.0 g/dL (90 g/L),
- •o Platelets < 100 x 109/L,
- •E9 Kaliemia < 3.5 mmol/L and/or total Calcemia < 2.2 mmol/L,
- •E10 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,
- •E11 Patients with known allergy to Plerixafor or its excipients.
- •E12 Previous (within 4 weeks) or current participation in another clinical study other than an observational study.
研究者
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