European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 290
- 试验地点
- 92
- 主要终点
- Occurrence of disease progression within 14 days (primary end point, EU SolidAct part A)
研究概览
简要总结
EU SolidAct is a randomized, multifactorial, adaptive platform trial for COVID-19 and emerging infectious diseases and pandemics. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to hospital with COVID-19. The platform is designed for running phase 2 and phase 3 trials, and with modular data capture (end point/safety data, biobanking, add-on studies) depending on the capacity of participating sites. The study consists of two parts with different primary end points depending on disease stage: EU SolidAct part A includes hospitalized patients with moderate disease, whereas EU SolidAct part B includes hospitalized patients with severe and critical disease.
详细描述
There is an urgent need for developing an adaptive pan-European research platform for rapid and coordinated investigation of new candidate drugs during ongoing pandemics. EU-SolidAct is an Adaptive Platform Trial master protocol developed for evaluating drug interventions in hospitalized patients with COVID-19. While this master protocol is developed for therapeutic interventions in hospitalized patients, it could also form the basis for trial protocols on other interventions and/or in non-hospitalized populations. The protocol is additionally developed to facilitate a joint European response to the challenge of evaluating interventions during future epidemics. The described disease states and endpoints may need to be adapted to the epidemic in question.
EU-SolidAct is a European, multicentre, randomized, parallel, phase 2 and 3 platform trial on drug interventions, both new and repurposed, single or in combination, in hospitalized adult patients with moderate or severe COVID-19, as defined by the WHO Working Group on the Clinical Characterisation and Management of COVID-191. Participants with moderate disease (WHO score 4-5) will be eligible for EU-SolidAct Part A, whereas participants with severe/critical disease (WHO score 6-9) will be eligible for EU-SolidAct Part B. This might include participants progressing from Part A.
In Part A of phase 3 confirmatory trials, the primary objective is to determine the effect of therapeutic interventions on occurrence of disease progression, from moderate disease to severe/critical disease or death within 14 days. In Part B, the primary objective is to determine the effect of therapeutic interventions on occurrence of death within 60 days.
In phase 2 the default objective for both parts is to explore the effect of the therapeutic intervention on respiratory dysfunction at day 5. Other objectives, e.g. effect on virological outcomes may be considered based on the treatment mode of action.
In phase 3 trials, both superiority and non-inferiority hypotheses may be evaluated. In phase 2 trials, only superiority hypotheses will be evaluated. In addition to single treatments, combination of treatments could also be assessed through factorial design. EU-SolidAct is designed to be adaptive and to enable inclusion of hospitals in Europe and beyond, regardless of epidemic waves and available resources. This requires the master protocol to be modular, ranging from a core set of outcomes to more advanced data capture. Hospitals will access the study on different pre-set levels, ranging from a core set of clinical endpoints and safety measures, to a more advanced level with biobanking and possibilities for add-on studies
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)
盲法说明
Corresponding placebo tablets
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active arm
4mg Baricitinib up to 14 days + SoC
干预措施: Baricitinib (Drug)
Comparator
Matching placebo up to 14 days + SoC
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of disease progression within 14 days (primary end point, EU SolidAct part A)
时间窗: 14 days
The primary outcome for phase 3 trials in EU SolidAct part A is occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10)
SpO2/FiO2-ratio at day 5 (primary end point, phase 2 trials)
时间窗: 5 days
In phase 2 exploratory trials, the default primary objective for both part A and B is to explore the effect of the intervention on respiratory dysfunction assessed by SpO2/FiO2-ratio at day 5
Occurrence of death within 60 days (primary end point, EU SolidAct part B)
时间窗: 60 days
The primary outcome for phase 3 trials in EU SolidAct part B is occurrence of death within 60 days
次要结局
- Occurrence of disease progression within 28 days (shared secondary end point for part A and B)(28 days)
- Disease state at Day 15 and Day 29 (shared secondary end point for part A and B)(28 days)
- Time to first hospital discharge (shared secondary end point for part A and B)(90 days)
- SpO2/FiO2-ratio at Day 3, 5 and 8 (shared secondary end point for part A and B)(8 days)
- Occurrence of serious adverse events within 90 days (shared secondary end point for part A and B)(90 days)
- Time to sustained recovery (shared secondary end point for part A and B)(90 days)
- Time from randomization to recovery (shared secondary end point for part A and B)(90 days)
- Viral clearance during hospitalization (shared secondary end point for part A and B)(Days 1, 3, 5, 8 and 15)
- Patient related outcomes at day 90 (shared secondary end point for part A and B)(90 days)
研究者
Marius Trøseid
Associated professor, MD, PhD
Oslo University Hospital