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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Quality of Life; Covid19; Exercise Capacity; Lung Function

Treatments: Biological: Vaccination with BionTech Vaccine; Biological: Vaccination with Coronavac vaccine; Biological: third dose vaccination with CoronaVac vaccine; Biological: third dose vaccination with BionTech vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04611243

2020.229

Details and patient eligibility

About

(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)

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: Unwilling to be follow up

Trial design

700 participants in 5 patient groups

COVID survivors

Vaccination with CoronaVac vaccine

Treatment:

Biological: Vaccination with Coronavac vaccine

Vaccination with BionTech vaccine

Treatment:

Biological: Vaccination with BionTech Vaccine

third dose vaccination with CoronaVac vaccine

Description:

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).

Treatment:

Biological: third dose vaccination with CoronaVac vaccine

third dose vaccination with BionTech vaccine

Description:

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).

Treatment:

Biological: third dose vaccination with BionTech vaccine