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临床试验/NCT04611243
NCT04611243招募中不适用

Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2020年5月22日最近更新:
适应症

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

  1. To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years.
  2. To assess the longevity of the serology response to SARS-CoV2.
  3. To investigate the association of the neutralization titer in plasma from different vaccinated cohorts to its protection of infection using in vivo model
  4. 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.
  5. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof David Shu Cheong Hui

Professor

Chinese University of Hong Kong

研究点 (1)

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