Lung function impairment and injury in post COVID 19 infection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 4.SGRQ: Respirtory symptoms, problems, treatment & activities
研究概览
简要总结
Since the initial reports of the recent new COVID-19 virus infection (SARS-CoV2) in December 2019, the outbreak has rapidly spread and escalated resulting in this disease being formally declared a pandemic on 11 March 2020 by the World Health Organization.
Transmission dynamics are currently evolving and high person-to-person spread has been confirmed in community and healthcare settings in China and other countries.
Pneumonia appears to be the most frequent serious manifestation of infection and Acute respiratory distress syndrome (ARDS) is the major complication in patients, with high fatality rate. These are likely to heal with fibrosis and result in residual lung damage and lung function impairment. This has not been well studied. When the study was conceived, only one study in China has tested lung function in a small number of subjects, subsequently few others had published their findings. There are no studies from India. We propose to evaluate these patients with lung function testing, exercise capacity, lung scarring as seen by imaging and health related quality of life
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult inpatients (more than 18 years and older) with positive SARS-CoV-2 RNA detection (throat swab) results and diagnosed with COVID-19
- •Willing to sign informed consent.
排除标准
- •Patients not willing to consent or unable to come for follow-up.
结局指标
主要结局
4.SGRQ: Respirtory symptoms, problems, treatment & activities
时间窗: 4 to 6 weeks, 3 months, 6 months
2.6 Min walk test parameters: 6 min walk distance, Distance Saturation Product, Lowest SPO2, Dyspnea Borg scale
时间窗: 4 to 6 weeks, 3 months, 6 months
1.Lung function paramenters: FEV1, FVC, TLC, RV, DLco, DLco/VA
时间窗: 4 to 6 weeks, 3 months, 6 months
3.CXR/HRCT: Fibrosis, Consolidation, bronchiectasis etc.
时间窗: 4 to 6 weeks, 3 months, 6 months
次要结局
未报告次要终点