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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

Conditions
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Lung Function, Exercise Capacity, Quality of Life, Covid19

Intervention / Treatment
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* Biological: third dose vaccination with CoronaVac vaccine
* Biological: third dose vaccination with BionTech vaccine
* Biological: Vaccination with Coronavac vaccine
* Biological: Vaccination with BionTech Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been discharged from hospital following treatment for COVID-19 - Exclusion Criteria: Unwilling to be follow up -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID survivors<br> | |
| Vaccination with CoronaVac vaccine<br> | Biological: Vaccination with Coronavac vaccine<br>* Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart<br>|
| Vaccination with BionTech vaccine<br> | Biological: Vaccination with BionTech Vaccine<br>* Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart<br>|
| third dose vaccination with CoronaVac vaccine<br>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<br>* Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of CoronaVac vaccine<br>|
| third dose vaccination with BionTech vaccine<br>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<br>* Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spirometry | FEV1 and FVC | 3 years | 
| Lung volume | Litres | 3 years | 
| 6 minute walk distance | meters | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life by SF36 questionnaire | scores in all domains | 3 years | 
| serology and T cell response | titers | 3 years |