World Health Organization, Geneva, Switzerland
University of British Columbia, Vancouver, British Columbia, Canada.
BMJ Open. 2023 Aug 17;13(8):e071346. doi: 10.1136/bmjopen-2022-071346.
SARS-CoV-2 has been identified as the cause of the disease officially named COVID-19, primarily a respiratory illness. COVID-19 was characterised as a pandemic on 11 March 2020. It has been estimated that approximately 20% of people with COVID-19 require oxygen therapy. Oxygen has been listed on the WHO Model List of Essential Medicines List and Essential Medicines List for Children for almost two decades. The COVID-19 pandemic has highlighted, more than ever, the acute need for scale-up of oxygen therapy. Detailed data on the use of oxygen therapy in low-and-middle income countries at the patient and facility level are needed to target interventions better globally.
We aim to describe the requirements and use of oxygen at the facility and patient level of approximately 4500 patients with COVID-19 in 30 countries. Our objectives are specifically to characterise type and duration of different modalities of oxygen therapy delivered to patients; describe demographics and outcomes of hospitalised patients with COVID-19; and describe facility-level oxygen production and support. Primary analyses will be descriptive in nature. Respiratory support transitions will be described in Sankey plots, and Kaplan-Meier models will be used to estimate probability of each transition. A multistate model will be used to study the course of hospital stay of the study population, evaluating transitions of escalating respiratory support transitions to the absorbing states.
WHO Ad Hoc COVID-19 Research Ethics Review Committee (ERC) has approved this global protocol. When this protocol is adopted at specific country sites, national ERCs may make require adjustments in accordance with their respective national research ethics guidelines. Dissemination of this protocol and global findings will be open access through peer-reviewed scientific journals, study website, press and online media.
NCT04918875.
SARS-CoV-2 已被确定为正式命名为 COVID-19 的疾病的病因，主要是一种呼吸道疾病。COVID-19 于 2020 年 3 月 11 日被认定为大流行。据估计，大约 20%的 COVID-19 患者需要氧疗。氧气已被列入世界卫生组织基本药物清单和儿童基本药物清单近二十年。COVID-19 大流行比以往任何时候都更突出了大规模扩大氧疗的迫切需要。需要在患者和医疗机构层面提供有关低中等收入国家使用氧疗的详细数据，以便在全球范围内更好地确定干预措施的目标。
我们旨在描述大约 30 个国家的 4500 名 COVID-19 患者在医疗机构和患者层面的氧气需求和使用情况。我们的具体目标是描述给予患者的不同类型和持续时间的氧疗；描述 COVID-19 住院患者的人口统计学和结局；描述医疗机构层面的氧气生产和支持。主要分析将具有描述性。呼吸支持的转变将在 Sankey 图中描述，Kaplan-Meier 模型将用于估计每个转变的概率。多状态模型将用于研究研究人群的住院病程，评估升级呼吸支持转变为吸收状态的过程。
世界卫生组织临时 COVID-19 研究伦理审查委员会 (ERC) 已批准该全球方案。当该方案在特定国家/地区站点实施时，国家/地区 ERC 可能需要根据各自的国家/地区研究伦理准则进行调整。本方案和全球研究结果将通过同行评议的科学期刊、研究网站、新闻和在线媒体公开获取。
NCT04918875。
