We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04611243
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : August 23, 2021
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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