Cardiopulmonary and Immunological Impacts of Covid-19 in a Cohort of Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- measurement of pulmonary function changes either obstructive or restrictive also lung diffusion and if there is remaining interstitial fibrosis
研究概览
简要总结
Study rationale and aim: Resolving the COVID-19 pandemic quickly hinges on a crucial factor: how well a person's immune system remembers SARS-CoV-2, the virus behind the disease, after an infection has resolved and the patient is back in good health. This phenomenon, called immune memory, helps our bodies avoid reinfection by a bug persons have had before and influences the potency of life-saving treatments and vaccines. Also, the new coronavirus causes cardiac and pulmonary inflammation. So, our study planned to measure the cardiopulmonary and immunological changes in treated COVID-19 patients. Specific objectives: Measurement the duration of existence of COVID-19 IgM and IgG antibody in patient's plasma, detection of cardiac changes, pulmonary radiological and functional changes after COVID-19 infection. This could help detection of functional impairment in COVID-19 survivors which may have economic and social impact. Also, investigator will assess possible protective immune response following infection which may affect vaccination schedule. Methods: One hundred RT- PCR positive COVID-19 patients will be enrolled. HRCT chest, lateral flow immunoassay, spirometry, DLCO and Echo will be done on after 3, 6 and 12 months of discharge.
详细描述
• Background and significance:
COVID-19 (Coronavirus Disease-2019) is a public health emergency of international concern. Radiological, lung function changes were reported in different studies of pulmonary viral infection.
After a patient has recovered from severe acute respiratory syndrome (SARS), CT shows transient interlobular septal thickening and reticulation over a course of several weeks to months. The reticulation appears after the 2nd week and peaks around the 4th week. One-third of patients with persistent respiratory symptoms will have imaging findings of fibrosis, including interlobular and intralobular reticulation, traction bronchiectasis, and, rarely, honeycombing. Areas of air trapping, caused by damage to ciliated respiratory epithelium, have been reported in 92% of patients who have recovered from pneumonia and are less likely to resolve completely. Likewise, in patients with MERS, although the majority fully recover, 33% show evidence of lung fibrosis on follow-up imaging. These patients were commonly older, had prolonged ICU admission, and had greater lung involvement in the acute phase of the disease.
CT was performed 1 year after MERS-CoV infection in 65 (89%) patients. Radiological sequelae were revealed in 25% (4/16), 63% (19/30), and 95% (18/19) of patients in the no, mild, and severe pneumonia groups, respectively (P < 0.001). The median radiological sequelae score was 0, 1, and 3 in the no, mild, and severe pneumonia groups, respectively, and the radiological sequelae scores were significantly correlated with the severity of pneumonia (P < 0.001). The finding that more severe MERS pneumonia resulted in more impaired lung function strongly suggests that pulmonary sequelae can remain at least 1 year after MERS-CoV pneumonia, which is also supported by the correlation of radiological sequela correlated with the severity of MERS pneumonia.
A previous study showed that 24% of SARS survivors have impaired DLCO and 5% reduced lung volume at 12 months.
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
- •pcr positive for covid -19 who are survived
排除标准
- •dead patient uncooperative
结局指标
主要结局
measurement of pulmonary function changes either obstructive or restrictive also lung diffusion and if there is remaining interstitial fibrosis
时间窗: 12 months
pulmonary function include lung volumes in millimetre and lung capacities
measurement for cardiac function and ejection fraction changes and if there is changes in pulmonary artery pressure
时间窗: 12 months
Ejection fraction ,myocardial contractility,pulmonary artery pressure
次要结局
- assessment of IGM and IGG level and if there is immunological changes(12 months)