Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,130
- 试验地点
- 2
- 主要终点
- Time to all-cause mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization
研究概览
简要总结
Coronavirus-2019 disease (COVID-19) and community-acquired pneumonia are significant problems of modern medicine. Pneumonia is the most common severe complication of COVID-19. But at the same time, COVID-19 is not the only cause of community-acquired pneumonia. Moreover, pneumonia is only one of the numerous possible severe complications of COVID-19. Medical centers specialized for the hospital treatment of patients with severe COVID-19 and community-acquired pneumonia were organized in different regions of Russia during coronavirus pandemic-2020. The indications for hospitalization to one of these centers based in the National Medical and Surgical Center (NMSC) are: confirmed or suspected severe COVID-19 or community-acquired pneumonia.
A prospective medical registry of such patients hospitalized to NMSC, is intended to analyze and compare their clinical and instrumental data, co-morbidity, treatment, short-term and long-term outcomes in real clinical practice.
Stage 1. Hospital treatment in NMSC
Duration of this stage: from the date of admission to the hospital up to the date of discharge from the hospital / or up to the date of death during the reference hospitalization. The date of admission to the hospital will be the date of enrollment to the study.
Evaluation of electronic health record data using the Medical Information System (MIS). Assessment of the outcomes of the hospital phase (discharge from the hospital, death) and significant events (acute respiratory and pulmonary failure, requiring mechanical ventilation; cardiovascular events - myocardial infarction, cerebral stroke, acute heart failure, paroxysmal heart rhythm disturbances, bleedings, thrombosis of large vessels and thromboembolic complications). A survey of patients to clarify data on risk factors, somatic diseases, and drug therapy before hospitalization.
COVID-19 was diagnosed when severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was confirmed by Polymerase chain reaction (PCR). Pneumonia was confirmed according to computerized tomography (CT) data.
Stage 2. Prospective outpatient follow-up for 24 months
Duration of this stage: 24 months after discharge from the hospital This work will be delivered by investigators from the National Medical Research Center for Therapy and Preventive Medicine.
Evaluation of long-term outcomes and events among residents of Moscow and the Moscow Region according to a patient survey (contact by phone for 30-60 days, 6 months, 12 and 24 months after discharge from the hospital) and medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients hospitalized to the National Medical and Surgical Center named after N.I.Pirogov of the Ministry of Health of Russia (NMSC) with suspected or confirmed COVID-19 or community-acquired pneumonia.
- •Age 18 years and older.
- •Permanent residency in Russia.
排除标准
- •Permanent residency outside of Russia.
- •The patient's refusal to participate in the study.
结局指标
主要结局
Time to all-cause mortality, nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization
时间窗: from discharge up to two years after reference hospitalization
Time to all-cause mortality or Artificial Pulmonary Ventilation (APV)
时间窗: from admission to discharge or death during reference hospitalization, assessed up to 90 days
Overall survival
时间窗: from admission to discharge or death during reference hospitalization, assessed up to 90 days
次要结局
- Proportion of patients with Hb <90 g/l (9.0 g/dl) at any point during hospitalization(from admission to discharge or death during reference hospitalization, assessed up to 90 days)
- Proportion of patients with severe pneumonia(from admission to discharge or death during reference hospitalization, assessed up to 90 days)
- Proportion of patients with low oxygen saturation value(from admission to discharge or death during reference hospitalization, assessed up to 90 days)
- Proportion of patients hospitalized or transferred to Intensive Care Unit (ICU)(from admission to discharge or death during reference hospitalization, assessed up to 90 days)
- Overall survival(from discharge up to two years after reference hospitalization)
- Time to nonfatal myocardial infarction, nonfatal cerebral stroke, and coronary or carotid revascularization(from discharge up to two years after reference hospitalization)
- Time to pneumonia/recurrent pneumonia(from discharge up to two years after reference hospitalization)
- Time to primary or recurrent coronavirus infection disease (COVID-19)(from discharge up to two years after reference hospitalization)