EUCTR2021-000598-95-ES进行中（未招募）1 期
A Phase 2, randomized, double-blind, placebo-controlled, multi-center trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 or other disorders
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Camurus AB
- 入组人数
- 40
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
- •Male or female patient, >18 years old at the time of screening
- •ARDS according to the Berlin definition at the time of randomization:
- •- PaO2/FiO2 <300 mmHg (<40 kPa) with positive end-expiratory pressure or CPAP > or = 5 cm H2O on Day 1
- •- Bilateral lung opacities not fully explained by effusions, lobular/lung collapse, or nodules as determined by chest imaging (X-ray or computed tomography [CT] scan)
- •- Respiratory failure not fully explained by cardiac failure or fluid overload
- •Written informed consent provided by the patient (or legally authorized representative) prior to performing any trial related procedures
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •A candidate for hospice or palliative care
- •Treatment with somatostatin analogue (e.g. octreotide or lanreotide), pasireotide, bromocriptine/cabergoline or pegvisomant in the past 3 months or plans to receive such treatment during the trial period
- •Treatment with chloroquine or hydroxychloroquine in the past 30 days
- •Treatment with concomitant medication(s) with a known risk of Torsades de Pointes within 7 days prior to screening
- •Currently taking part in another interventional clinical trial
- •History of hypersensitivity or allergy to octreotide
- •Evidence of poorly controlled diabetes (hemoglobin A1c > or = 10%) at screening
- •Known history of, or evidence at screening of, QT prolongation, or having other risk factors for Torsades de Pointes according to the Investigator’s judgement
- •Hepatic- or pancreatic-related disorder, including hepatic cirrhosis, viral hepatitis, gallbladder or bile duct disease, acute or chronic pancreatitis or symptomatic cholelithiasis
- •Cardiac disease:
- •- Myocardial infarction or coronary artery bypass graft within 6 months, or
- •- Ongoing arrhythmias, complete left bundle branch block or high-grade atrioventricular heart block
- •Untreated or uncontrolled hypothyroidism
- •Abnormal liver laboratory parameters at screening: aspartate aminotransferase or alanine aminotransferase > or = 3.0 × upper limit of normal (ULN) combined with total bilirubin >2 × ULN and amylase or lipase > or = 3.0 × ULN
- •Severe renal failure requiring dialysis
- •Malignancy or other irreversible disease or condition for which 6-month mortality is estimated at 50% or more
- •Pre-existing neuromuscular disease impairing spontaneous ventilation
- •Any other serious medical condition that, in the Investigator’s opinion, may prevent the patient from safely participating in the trial
- •Pregnant or lactating women
- •On the staff, affiliated with, or a family member of the personnel directly involved with this trial
研究者
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