Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- 6 minute walk distance
研究概览
简要总结
(a) Objectives
- To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years.
- To assess the longevity of the serology response to SARS-CoV2.
- To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model
- To investigate the SARS-CoV-2 specific cellular and humoral immunities as well as their determinant factors from community subjects who have received different types of COVID-19 vaccines.
- To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)
详细描述
The health conditions of adults (N=300) who recovered from varying severity of COVID-19 will be assessed and their blood are collected at 6, 12, 24 and 36 months after discharge. The assessment package includes: lung function tests, 6-min walk distance, chest radiographs/CT, and SF36 General Health questionnaire. Blood samples from community cohorts will be collected from before and up to 36 months after receiving one of the three COVID-19 vaccines (N=200 per vaccine type). The kinetics of SARS-CoV-2 specific humoral and cellular immunities from both convalescent and vaccinated cohorts are determined by neutralization assay and by measuring specific T cell responses upon stimulation of SARS-CoV-2 specific peptide library respectively. The antiviral level of the human plasma with various neutralization titer collected from different vaccinated cohorts will be tested in mouse model and ADCC assay.
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 who have been discharged from hospital following treatment for COVID-19 -
排除标准
- •Unwilling to be follow up
结局指标
主要结局
6 minute walk distance
时间窗: 3 years
meters
Lung volume
时间窗: 3 years
Litres
spirometry
时间窗: 3 years
FEV1 and FVC
次要结局
- quality of life by SF36 questionnaire(3 years)
- serology and T cell response(3 years)
研究者
Prof David Shu Cheong Hui
Professor
Chinese University of Hong Kong
