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

• ClinicalTrials.gov Identifier: NCT04611243
• Recruitment Status: Recruiting
• First Posted: November 2, 2020
• Last Update Posted: August 23, 2021
• Sponsor: Chinese University of Hong Kong
• Collaborators: The University of Hong Kong; Health and Medical Research Fund
• Information provided by (Responsible Party): Prof David Shu Cheong Hui, Chinese University of Hong Kong

Tracking Information

• First Submitted Date: June 29, 2020
• First Posted Date: November 2, 2020
• Last Update Posted Date: August 23, 2021
• Actual Study Start Date: May 22, 2020
• Estimated Primary Completion Date: August 18, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2021)

• spirometry [ Time Frame: 3 years ]
  FEV1 and FVC
• Lung volume [ Time Frame: 3 years ]
  Litres
• 6 minute walk distance [ Time Frame: 3 years ]
  meters

Original Primary Outcome Measures (submitted: October 29, 2020)

• spirometry [ Time Frame: 2 years ]
  FEV1 and FVC
• Lung volume [ Time Frame: 2 years ]
  Litres
• 6 minute walk distance [ Time Frame: 2 years ]
  meters

Current Secondary Outcome Measures (submitted: August 17, 2021)

• quality of life by SF36 questionnaire [ Time Frame: 3 years ]
  scores in all domains
• serology and T cell response [ Time Frame: 3 years ]
  titers

Original Secondary Outcome Measures (submitted: October 29, 2020)

• quality of life by SF36 questionnaire [ Time Frame: 2 years ]
  scores in all domains
• serology and T cell response [ Time Frame: 2 years ]
  titers

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Blood will be taken for serology testing and T cell response after discharge, 6, 12, 18 and 24 months.

• 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.

Condition

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

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
• 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

Study Groups/Cohorts

• COVID survivors
• Vaccination with CoronaVac vaccine
  Intervention: Biological: Vaccination with Coronavac vaccine
• Vaccination with BionTech vaccine
  Intervention: Biological: Vaccination with BionTech Vaccine
• 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).
  Intervention: Biological: third dose vaccination with 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).
  Intervention: Biological: third dose vaccination with BionTech vaccine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 17, 2021): 700
• Original Estimated Enrollment (submitted: October 29, 2020): 80
• Estimated Study Completion Date: February 17, 2025
• Estimated Primary Completion Date: August 18, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Exclusion Criteria: Unwilling to be follow up

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Susanna Ng, MBChB; 85235053128; drsssng@gmail.com

Contact: Karen Yiu, BSc; 85235053532; ysyiu@cuhk.edu.hk

• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT04611243
• Other Study ID Numbers: 2020.229
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: data pending

• Current Responsible Party: Prof David Shu Cheong Hui, Chinese University of Hong Kong
• Original Responsible Party: Same as current
• Current Study Sponsor: Chinese University of Hong Kong
• Original Study Sponsor: Same as current

Collaborators

• The University of Hong Kong
• Health and Medical Research Fund

Investigators

• Principal Investigator: David S Hui, MD; Chinese University of Hong Kong

• PRS Account: Chinese University of Hong Kong
• Verification Date: August 2021