Clinical trial NCT04611243: Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
Official title: Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Function
Exercise Capacity
Quality of Life
Covid19
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Health and Medical Research Fund
First posted: 2020-11-02
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (about 80) who have been discharged following treatment for COVID-19 will be followed up at the Prince of Wales Hospital at 4 weeks after discharge, 6, 12, 18 and 24 months.

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.

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

Exclusion Criteria: Unwilling to be follow up

-

Primary outcomes:
measure: spirometry
timeFrame: 3 years
measure: Lung volume
timeFrame: 3 years
measure: 6 minute walk distance
timeFrame: 3 years
Secondary outcomes:
measure: quality of life by SF36 questionnaire
timeFrame: 3 years
measure: serology and T cell response
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: David S Hui, MD
role: PRINCIPAL_INVESTIGATOR
References: