Defining COVID-19 Infection Severity on Presentation to Hospital: a Multicentre Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
In the assessment of severity in coronavirus disease 2019 (COVID-19), the modified Brit_x0002_ish Thoracic Society (mBTS)，CURB65 et al. rules identifies patients with severe pneumonia but not patients who might be suitable for home management. A multicentre prospective study was conducted to derive and validate a practical severity assessment model for stratifying adults hospitalised with COVID-19 into different management groups.
详细描述
- Screening interested participants should sign the appropriate informed consent (ICF) prior to completion any study procedures.
- The investigator will review symptoms, risk factors, and other non-invasive inclusion and exclusion criteria.
- The following is the general sequence of events during the 30-day evaluation period:
- Completion of baseline procedures Participants were assessed for 30 days and completed all safety monitoring.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with novel coronavirus infection meeting the criteria of The New Coronavirus Pneumonia Diagnosis and Treatment Program (Ninth Edition);
- •Participants are willing to participate in this study and follow the research plan;
- •Participants or legally authorized representatives can give written informed consent approved by the Ethics Review Committee that manages the website.
排除标准
- •pneumonia was (a) not the primary cause for hospital admission, (b) an expected terminal event,or (c) distal to bronchial obstruction;
- •patients with tuberculosis,bronchiectasis,solid organ and haematological malignancies or human immuno deficiency virus (HIV) infection;
- •patients who had been in hospital within the previous 14days, were immunocompromised,or had previously been entered in the study;
- •nursing home residents.Participation in other clinical study.
结局指标
主要结局
Mortality
时间窗: 30days
Mortality within 30days after diagnosis; Death from any cause
Deterioration of the condition
时间窗: Day 1 to 30 days
Deterioration of the condition: refer to Guidelines for the Diagnosis and Treatment of Novel Coronavirus Infection by the National Health Commission (Trial Version 9) The development from asymptomatic to mild/general-type. The development from mild to general-type/severe type The development from general-type to severe/critical type The development from severe to critical type
次要结局
- Time to sustained disappearance of clinical symptoms(Up to 30 days)
- Safety assessment Results: such as AEs and SAEs through Day 30(Up to 30 days)
- Percentage of participants with no clinical symptom(Day 3, 5, 7, 10, 14, 21 and 28)
- Percentage of participants who turned negative for SARS-CoV-2 and/or COVID-19 antigen(Day 3, 5, 7, 10, 14, 28)