Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
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ClinicalTrials.gov Identifier: NCT04611243 |
Recruitment Status :
Recruiting
First Posted : November 2, 2020
Last Update Posted : August 23, 2021
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(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)
Condition or disease | Intervention/treatment |
---|---|
Lung Function Exercise Capacity Quality of Life Covid19 | Biological: third dose vaccination with CoronaVac vaccine Biological: third dose vaccination with BionTech vaccine Biological: Vaccination with Coronavac vaccine Biological: Vaccination with BionTech Vaccine |
Study Type : | Observational |
Estimated Enrollment : | 700 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19 |
Actual Study Start Date : | May 22, 2020 |
Estimated Primary Completion Date : | August 18, 2024 |
Estimated Study Completion Date : | February 17, 2025 |

Group/Cohort | Intervention/treatment |
---|---|
COVID survivors | |
Vaccination with CoronaVac vaccine |
Biological: Vaccination with Coronavac vaccine
Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart |
Vaccination with BionTech vaccine |
Biological: Vaccination with BionTech Vaccine
Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart |
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).
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Biological: third 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 |
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
Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine |
- spirometry [ Time Frame: 3 years ]FEV1 and FVC
- Lung volume [ Time Frame: 3 years ]Litres
- 6 minute walk distance [ Time Frame: 3 years ]meters
- quality of life by SF36 questionnaire [ Time Frame: 3 years ]scores in all domains
- serology and T cell response [ Time Frame: 3 years ]titers
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria: Patients who have been discharged from hospital following treatment for COVID-19 -
Exclusion Criteria: Unwilling to be follow up
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611243
Contact: Susanna Ng, MBChB | 85235053128 | drsssng@gmail.com | |
Contact: Karen Yiu, BSc | 85235053532 | ysyiu@cuhk.edu.hk |
Hong Kong | |
Prince of Wales Hospital | Recruiting |
Hong Kong, Hong Kong | |
Contact: Susanna So-Shan Ng 3505 2785 drsssng123@yahoo.com.hk |
Principal Investigator: | David S Hui, MD | Chinese University of Hong Kong |
Responsible Party: | Prof David Shu Cheong Hui, Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT04611243 |
Other Study ID Numbers: |
2020.229 |
First Posted: | November 2, 2020 Key Record Dates |
Last Update Posted: | August 23, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | data pending |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |