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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611243
• Other study ID #: 2020.229
• Status: Recruiting
• Start date: May 22, 2020
• Est. completion date: February 17, 2025

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Susanna Ng, MBChB
• Phone: 85235053128
• Email: drsssng[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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 information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: February 17, 2025
• Est. primary completion date: August 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria: Unwilling to be follow up

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Related Conditions & MeSH terms

• COVID-19
• Covid19
• Exercise Capacity
• Lung Function
• Quality of Life

Intervention

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
• 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
• Vaccination with Coronavac vaccine
Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart
• Vaccination with BionTech Vaccine
Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Health and Medical Research Fund, The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spirometry	FEV1 and FVC	3 years
Primary	Lung volume	Litres	3 years
Primary	6 minute walk distance	meters	3 years
Secondary	quality of life by SF36 questionnaire	scores in all domains	3 years
Secondary	serology and T cell response	titers	3 years