Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients With ventiLatory Support (ESSENTIAL) A Randomized, Double-blind, Placebo-controlled Study With Adaptive Features
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Inotrem
- 入组人数
- 220
- 试验地点
- 17
- 主要终点
- Incidence of adverse events until day 28
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will be tested versus placebo.
All patients with a diagnosis of COVID-19, and a requirement for respiratory support will be considered for study participation. The applicable local requirements for informed consent will be followed. Where permissible, an emergency consent procedure will be followed for patients unable to provide consent by themselves. All potential study patients will receive standard of care treatment throughout the study. Patients will receive a continuous intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment with study drug must be initiated as early as possible but no later than 48 hours after the initiation of ventilatory support (Patients will be treated for 5 days or until discharge from critical care, whichever is sooner). Follow-up visits will be performed on days 8 and 14. The end of study visit is at day 28. A further follow up visit will be undertaken on day 60.
详细描述
ESSENTIAL was a randomized, double-blind, placebo-controlled trial, in which one dose of nangibotide was tested versus placebo. It took place in 14 sites in France and Belgium. The study was overseen by an independent Data Monitoring Committee (DMC).
The study was divided into two parts running sequentially without unblinding. Part 1 evaluated safety and tolerability study and included 60 patients, randomized in a 2:1 ratio of nangibotide to placebo. Part 2 included all recruited patients with an initially planned sample size of 370 patients, randomized in a 1:1 ratio of nangibotide to placebo.
All patients or their legally authorised representatives provided written informed consent or, in relevant countries, an independent physician, confirmed patient eligibility for enrolment in the trial.
Patients received a continuous intravenous infusion of nangibotide at 1.0 mg/kg/h or a matching placebo for 5 days (or until discharge from ICU, whichever was sooner). The treatment was in addition to standard of care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided informed consent (emergency consent according to local regulations where approved)
- •Age 18 to 75 years (inclusive)
- •Admitted to an intensive care unit
- •Treatment with High Flow Nasal Oxygen, non-invasive ventilation or invasive mechanical ventilation for acute respiratory failure caused by COVID-19 for less than 48 hours
- •A PaO2:FiO2 ratio of <200mmHg (<26.7kPa) with a FiO2 ≥0.6
- •Confirmed laboratory diagnosis of COVID-19 within 7 days of meeting screening criteria
排除标准
- •Known pregnancy (positive urine or serum pregnancy test)
- •Ongoing treatment with an immunomodulatory agent not included in the standard of care for COVID-19 (including participation in clinical trials of such agents)".
- •Body mass index (BMI) ≥ 40 kg/m2or weight ≥ 130 kg
- •Anticipated transfer to another hospital, which is not a study site within 72 hours
- •Expected to die within 6 months of treatment due to underlying chronic disease
- •Limitations of care in place during current hospital admission
研究组 & 干预措施
nangibotide
Continuous infusion of experimental agent for up to 120 hours
干预措施: nangibotide (Drug)
placebo
Continuous infusion of matched placebo for up to 120 hours
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of adverse events until day 28
时间窗: 28 days
Part 1
Clinical Status (7-point Ordinal Scale) assessed at Day 28
时间窗: 28 days
Part 2
次要结局
未报告次要终点