WHO Public Health Emergency "Solidarity" Clinical Trial for COVID-19 Treatments
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All cause Mortality
研究概览
简要总结
In early 2020 there were no approved anti-viral treatments for COVID19 Infection. The SOLIDARITY trial is a multicentre adaptive international randomised trial sponsored by Word Health Organization to determine the efficacy of Remdesivir (daily infusion for 10 days), or Acalabrutinib (orally twice daily for 10 days), or Interferon β1a(daily injection for 6 days) compared with local standard of care in patients admitted to hospital for COVID19 infection on all-cause mortality, stratified by severity of disease at the time of randomisation. The major secondary outcomes are duration of hospital stay and time to first receiving ventilation (or intensive care).
详细描述
Terminology: The novel coronavirus-induced disease first described in 2019 in China is designated COVID-19 (or COVID), and the pathogen itself (an RNA virus) is SARS-coronavirus-2 (SARS-CoV-2).
Background: In early 2020 there were no approved anti-viral treatments for COVID, and WHO expert groups advised that four re-purposed drugs, Remdesivir, Lopinavir (given with Ritonavir, to slow hepatic degradation), Interferon (β1a), and hydroxychloroquine (HCQ) should be evaluated in an international randomised trial. In addition, WHO provided guidelines that local physicians may consider when COVID-19 is suspected on clinical management of severe acute respiratory infection. However, following an interim analyses, the interim results of HCQ vs standard of care and lopinavir/ritonavir vs standard of care from the Solidarity/Discovery trials, the Solidarity trial Executive Group decided to stop the HCQ and the Lopinavir/ritonavir arms on the 3rd of July, 2020 due to futility; leaving 3 arms, i.e., remdesivir, Interferon (β1a), and standard of care.
On the 6th of August 2020, due to a review of the rationale and clinical evidence, the Executive Group of the Steering Committee of the Solidarity trial recommended that a new arm should be opened in the Solidarity trial, to evaluate the clinical efficacy of Acalabrutinib.
Simplicity of procedures: To facilitate collaboration even in hospitals that have become overloaded, patient enrolment and randomisation (via the internet) and all other trial procedures are greatly simplified, and no paperwork at all is required. Once a hospital has obtained approval, electronic entry of patients who have given informed consent takes only a few minutes. At the end of it, the randomly allocated treatment is displayed on the screen and confirmed by electronic messaging.
Randomisation: Adults (age ≥18 years) recently hospitalised, or already in hospital, with definite COVID and, in the view of the responsible doctor, no contra-indication to any of the study drugs will be randomly allocated between
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consenting adults (age ≥18) hospitalised with definite COVID-19
- •Patients without known allergy or contra-indications to any of the of the therapies and without anticipated transfer within 72 hours to a non- study hospital.
- •Patients admitted to a collaborating hospital Exclusion Criteria
- •AVAILABLE study drugs are contra-indicated (e.g., because of patient characteristics, chronic liver or heart disease, or some concurrent medication).
排除标准
- 未提供
研究组 & 干预措施
Local Standard of Care
Local Standard of Care
干预措施: Standard of Care (Other)
Remdesivir
Remdesivir (daily infusion for 10 days)
干预措施: Remdesivir (Drug)
Acalabrutinib
Acalabrutinib (orally twice daily for 10 days)
干预措施: Acalabrutinib (Drug)
Interferon
Interferon β1a(daily injection for 6 days).
干预措施: Interferon beta-1a (Drug)
结局指标
主要结局
All cause Mortality
时间窗: Number of days from hospital admission up to 28 days post discharge
次要结局
- Time to admission to the intensive care unit(Number of days from hospital admission to day of admission to intensive care unit up to 28 days post admission)
- Duration of hospital stay(Number of days from hospital admission to discharge up to 28 days post admission)
- Time to first receiving ventilation(Number of days from hospital admission to day of receiving ventilatory support up to 28 days post admission)