Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
- Conditions
- Lung FunctionQuality of LifeCovid19Exercise Capacity
- Interventions
- Biological: Vaccination with BionTech VaccineBiological: third dose vaccination with CoronaVac vaccineBiological: third dose vaccination with BionTech vaccineBiological: Vaccination with Coronavac vaccine
- Registration Number
- NCT04611243
- Lead Sponsor
- Chinese University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 700
Patients who have been discharged from hospital following treatment for COVID-19 -
Unwilling to be follow up
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vaccination with BionTech vaccine Vaccination with BionTech Vaccine - third dose vaccination with CoronaVac 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). third dose vaccination with BionTech 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). Vaccination with CoronaVac vaccine Vaccination with Coronavac vaccine -
- Primary Outcome Measures
Name Time Method Lung volume 3 years Litres
6 minute walk distance 3 years meters
spirometry 3 years FEV1 and FVC
- Secondary Outcome Measures
Name Time Method serology and T cell response 3 years titers
quality of life by SF36 questionnaire 3 years scores in all domains
Trial Locations
- Locations (1)
Prince of Wales Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong