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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04611243
Enrollment
700
Registered
2020-11-02
Start date
2020-05-22
Completion date
2026-02-17
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Exercise Capacity, Lung Function, Quality of Life

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.

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

Sponsors

The University of Hong Kong
CollaboratorOTHER
Health and Medical Research Fund
CollaboratorOTHER_GOV
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Unwilling to be follow up \-

Design outcomes

Primary

MeasureTime frameDescription
spirometry3 yearsFEV1 and FVC
Lung volume3 yearsLitres
6 minute walk distance3 yearsmeters

Secondary

MeasureTime frameDescription
quality of life by SF36 questionnaire3 yearsscores in all domains
serology and T cell response3 yearstiters

Countries

Hong Kong

Contacts

Primary ContactSusanna Ng, MBChB
drsssng@gmail.com85235053128
Backup ContactKaren Yiu, BSc
ysyiu@cuhk.edu.hk85235053532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026