A Real-world Retrospective Study of Disease Outcomes in Non-severe Coronavirus Disease 2019 (COVID-19) Patients With Risk Factors for Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Percentage of patients with COVID-19 progression
研究概览
简要总结
Retrospective analysis of real-world disease outcomes in non-severe COVID-19 patients with high risk factors of progression to severe disease, including death, without definitive anti-SARS-CoV-2 treatment
详细描述
This is a retrospective, observational, real-world study to review outcomes of Mild to Moderate COVID-19 patients admitted to Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine (hereinafter referred to as Ruijin Hospital) from March to June 2022. These patients should be with risk factors for progression to severe disease (including death) and without definitive anti-novel coronavirus (SARS-CoV-2) treatment. The database of this study will be the hospital information system (HIS) of Ruijin Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Age ≥18 years old;
- •A record of positive SARS-CoV-2 nucleic acid test results on the day of admission or on the second day;
- •Diagnosed as mild or common novel coronavirus pneumonia on admission, or with at least one of the following COVID-19-related symptoms on admission: fever, cough, sore throat, nasal congestion or runny nose, headache, muscle pain, nausea, vomiting, diarrhea , shortness of breath or difficulty breathing, chills or chills;
- •Documented or diagnosed high risk factors for progression to severe COVID-19 (including death) with one or more of the following:
- •Age ≥ 60 years
- •Cardiovascular disease (including congenital heart disease) or high blood pressure
- •Chronic lung disease (eg chronic obstructive pulmonary disease [COPD], asthma [moderate to severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
- •Has an immunosuppressive disorder or is receiving immunosuppressive therapy (eg, long-term use of corticosteroids or other immunosuppressive drugs leading to decreased immune function)
- •Obese or overweight (BMI>25 kg/m2)
- •Sickle cell disease
- •Active cancer
- •Chronic kidney disease
- •Current smokers
- •Neurodevelopmental disorders (eg, cerebral palsy, Down syndrome) or other conditions that cause medical complexity (eg, genetic or metabolic syndrome and severe congenital anomalies)
- •Need for relevant medical support (not related to COVID-19) (eg tracheostomy, gastrostomy or positive pressure ventilation, etc.)
排除标准
- •Diagnosed with severe/critical COVID-19 before or on the day of admission;
- •There is a data record of having received the following treatments before progression to severe/critical COVID-19:
- •Nematicavir/ritonavir combination package (ie Paxlovid)
- •SARS-CoV-2 monoclonal antibody (Ambavirumab/Romisevirumab)
- •Convalescent COVID-19 plasma
- •Other anti-SARS-CoV-2 drugs under investigation
结局指标
主要结局
Percentage of patients with COVID-19 progression
时间窗: up to 3 months
Percentage of patients with COVID-19 progression (defined as progression to severe/critical COVID-19 or death from any cause).
次要结局
- Length of hospital stay(up to 3 months)
- chest CT scan(up to 3 months)
- Percentage of participants(up to 3 months)
- SARS-CoV-2(up to 3 months)
- SARS-CoV-2 continuous negative(up to 3 months)
- SARS-CoV-2 Ct values(up to 3 months)
- safety(up to 3 months)