Lung FunctionNCT04611243
Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
An observational study of Lung Function and Exercise Capacity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Function, Exercise Capacity, Quality of Life
- What is being tested?
- third dose vaccination with CoronaVac vaccine, third dose vaccination with BionTech vaccine and Vaccination with Coronavac vaccine
- Type of treatment
- Vaccines
- How many people
- 700 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 May 2020to 17 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Susanna So-Shan Ng, 3505 2785, drsssng123@yahoo.com.hk
About this study
(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)
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.
- Conditions
- Lung Function, Exercise Capacity, Quality of Life, Covid19
- Being tested
- third dose vaccination with CoronaVac vaccine, third dose vaccination with BionTech vaccine, Vaccination with Coronavac vaccine, Vaccination with BionTech Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
third dose vaccination with CoronaVac vaccineBiological
Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of CoronaVac vaccine
third dose vaccination with BionTech vaccineBiological
Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine
Vaccination with Coronavac vaccineBiological
Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart
Vaccination with BionTech VaccineBiological
Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart
| Study group | Role | What they receive |
|---|---|---|
| COVID survivors | Not described | |
| Vaccination with CoronaVac vaccine | Not described Receives: Biological: Vaccination with Coronavac vaccine | |
| Vaccination with BionTech vaccine | Not described Receives: 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). Receives: 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). Receives: Biological: third dose vaccination with BionTech vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
spirometry
FEV1 and FVC
Measured: 3 years
Lung volume
Litres
Measured: 3 years
6 minute walk distance
meters
Measured: 3 years
Secondary outcomes (2)
quality of life by SF36 questionnaire
scores in all domains
Measured: 3 years
serology and T cell response
titers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start22 May 2020
- Primary completion18 Aug 2025 (estimated)
- Study completion17 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung FunctionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Health and Medical Research Fund
- Responsible party
- Principal investigator, Prof David Shu Cheong Hui, Chinese University of Hong Kong
- Investigators
- David S Hui, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611243
- Sponsor's protocol ID
- 2020.229
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2020
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data pending
Publications
Chan KKP, Ng SSS, Lui GCY, Leung HS, Wong KT, Chu WCW, Chan TO, Yiu KYS, Tso EYK, To KW, Ngai JCL, Yip TWH, Lo RLP, Ng JKC, Ko FWS, Hui DSC. Comparison of the 12-month impact of COVID-19 and SARS on physiological capacity and health-related quality of life. BMC Pulm Med. 2023 Nov 14;23(1):441. doi: 10.1186/s12890-023-02750-8.
PubMed 37964259
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04611243
- Acronym / sponsor ID
- 2020.229
- Conditions
- Lung Function, Exercise Capacity, Quality of Life, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Health and Medical Research Fund
- Study start
- 22 May 2020 (actual)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 17 Feb 2026 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(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)
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Biological: third dose vaccination with CoronaVac vaccineWe 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). |
| third dose vaccination with BionTech vaccine | – | Biological: third dose vaccination with BionTech vaccineWe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| third dose vaccination with CoronaVac vaccineHealthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of CoronaVac vaccine | Biological | third dose vaccination with CoronaVac vaccine |
| third dose vaccination with BionTech vaccineHealthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine | Biological | third dose vaccination with BionTech vaccine |
| Vaccination with Coronavac vaccineHealthy individuals to receive Coronavac vaccine 2 doses, 21 days apart | Biological | Vaccination with CoronaVac vaccine |
| Vaccination with BionTech VaccineHealthy individuals to receive BionTech vaccine 2 doses, 21 days apart | Biological | Vaccination with BionTech vaccine |
Primary outcome
spirometry
Time frame: 3 years
FEV1 and FVC
Lung volume
Time frame: 3 years
Litres
6 minute walk distance
Time frame: 3 years
meters
2 secondary outcomes
quality of life by SF36 questionnaire
Time frame: 3 years
serology and T cell response
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Derived from this study: PubMed 37964259Chan KKP, Ng SSS, Lui GCY, Leung HS, Wong KT, Chu WCW, Chan TO, Yiu KYS, Tso EYK, To KW, Ngai JCL, Yip TWH, Lo RLP, Ng JKC, Ko FWS, Hui DSC. Comparison of the 12-month impact of COVID-19 and SARS on physiological capacity and health-related quality of life. BMC Pulm Med. 2023 Nov 14;23(1):441. doi: 10.1186/s12890-023-02750-8.
- Individual participant dataSharing planned: Undecided. data pending
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Hui, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function and Exercise Capacity, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanna Ng, MBChB (85235053128, drsssng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spirometry (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.