CClinicalTrials.gg
RecruitingNCT04611243Updated Aug 21, 2024

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

An observational study in Lung Function, Exercise Capacity and Quality of Life, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started May 2020; still recruiting 6 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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)
Read the 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.

02

Conditions studied

  • Lung Function
  • Exercise Capacity
  • Quality of Life
  • Covid19

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 700 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (about 80) who have been discharged following treatment for COVID-19 will be followed up at the Prince of Wales Hospital at 4 weeks after discharge, 6, 12, 18 and 24 months.

Eligibility criteria

Inclusion Criteria: Patients who have been discharged from hospital following treatment for COVID-19 -

Exclusion Criteria: Unwilling to be follow up

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • COVID survivors
  • Vaccination with CoronaVac vaccine

    Biological: Vaccination with Coronavac vaccine

  • Vaccination with BionTech vaccine

    Biological: Vaccination with BionTech Vaccine

  • third dose vaccination with CoronaVac vaccine

    We propose to invite 80 participants who have already completed the 2 doses vaccination of CoronaVac with low level of neutralizing antibody at 1-month post-vaccination to join this additional study. They will be randomized to receive a booster dose of Coronavac or BionTech in equal numbers (n=40 each group).

    Biological: third dose vaccination with CoronaVac vaccine

  • third dose vaccination with BionTech vaccine

    We propose to invite 80 participants who have already completed the 2 doses vaccination of CoronaVac with low level of neutralizing antibody at 1-month post-vaccination to join this additional study. They will be randomized to receive a booster dose of Coronavac or BionTech in equal numbers (n=40 each group).

    Biological: third dose vaccination with BionTech vaccine

Interventions

  • Biologicalthird dose vaccination with CoronaVac vaccine

    Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of CoronaVac vaccine

  • Biologicalthird dose vaccination with BionTech vaccine

    Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine

  • BiologicalVaccination with Coronavac vaccine

    Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart

  • BiologicalVaccination with BionTech Vaccine

    Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart

06

What researchers measure

Primary outcomes

  1. spirometry

    FEV1 and FVC

    Time frame: 3 years

  2. Lung volume

    Litres

    Time frame: 3 years

  3. 6 minute walk distance

    meters

    Time frame: 3 years

Secondary outcomes

  1. quality of life by SF36 questionnaire

    scores in all domains

    Time frame: 3 years

  2. serology and T cell response

    titers

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Prince of Wales Hospital
    Hong Kong, Hong Kong
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — data pending

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04611243
Lead sponsor
Chinese University of Hong Kong
Collaborators
The University of Hong Kong, Health and Medical Research Fund
Responsible party
Prof David Shu Cheong Hui (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Nov 2, 2020
Start date
May 22, 2020
Primary completion
Aug 18, 2025 (estimated)
Completion
Feb 17, 2026 (estimated)
Last update
Aug 21, 2024

Study contacts

Susanna Ng, MBChB
Contact
drsssng@gmail.com
85235053128
Karen Yiu, BSc
Contact
ysyiu@cuhk.edu.hk
85235053532
David S Hui, MD
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion