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Clinical Trials/NCT04611243
NCT04611243
Recruiting
N/A

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

Chinese University of Hong Kong1 site in 1 country700 target enrollmentMay 22, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lung Function
Sponsor
Chinese University of Hong Kong
Enrollment
700
Locations
1
Primary Endpoint
6 minute walk distance
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

(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)

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 22, 2020
End Date
February 17, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof David Shu Cheong Hui

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Patients who have been discharged from hospital following treatment for COVID-19 -

Exclusion Criteria

  • Unwilling to be follow up

Outcomes

Primary Outcomes

6 minute walk distance

Time Frame: 3 years

meters

Lung volume

Time Frame: 3 years

Litres

spirometry

Time Frame: 3 years

FEV1 and FVC

Secondary Outcomes

  • quality of life by SF36 questionnaire(3 years)
  • serology and T cell response(3 years)

Study Sites (1)

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