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

(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)

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Covid19; Exercise Capacity; Lung Function
• Intervention / Treatment: Biological: Vaccination with Coronavac vaccine; Biological: Vaccination with BionTech Vaccine; Biological: third dose vaccination with CoronaVac vaccine; Biological: third dose vaccination with BionTech vaccine

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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Susanna Ng, MBChB; Phone Number: 85235053128; Email: drsssng@gmail.com
• Study Contact Backup: Name: Karen Yiu, BSc; Phone Number: 85235053532; Email: ysyiu@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Susanna So-Shan Ng; Phone Number: 3505 2785; Email: drsssng123@yahoo.com.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID survivors
Vaccination with CoronaVac vaccine	Biological: Vaccination with Coronavac vaccine; Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart
Vaccination with BionTech vaccine	Biological: Vaccination with BionTech Vaccine; Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart
third dose vaccination with CoronaVac vaccine; 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).	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; 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).	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spirometry	FEV1 and FVC	3 years
Lung volume	Litres	3 years
6 minute walk distance	meters	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life by SF36 questionnaire	scores in all domains	3 years
serology and T cell response	titers	3 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: The University of Hong Kong; Health and Medical Research Fund
• Investigators: Principal Investigator: David S Hui, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Estimated): August 18, 2025
• Study Completion (Estimated): February 17, 2026

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2020.229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: data pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No