NCT04611243

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Function
• Exercise Capacity
• Quality of Life
• Covid19

Interventions

Type	Name	Description
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
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
BIOLOGICAL	Vaccination with Coronavac vaccine	Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart
BIOLOGICAL	Vaccination with BionTech Vaccine	Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart

Timeline

• Start date: 2020-05-22
• Primary completion: 2025-08-18
• Completion: 2026-02-17
• First posted: 2020-11-02
• Last updated: 2024-08-21

Locations

1 site across 1 country: Hong Kong