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

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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

Study Description
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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)

Condition or disease Intervention/treatment
Lung Function Exercise Capacity Quality of Life Covid19 Biological: third dose vaccination with CoronaVac vaccine Biological: third dose vaccination with BionTech vaccine Biological: Vaccination with Coronavac vaccine Biological: 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 Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Function, Exercise Capacity, and Serology Responses in Patients With COVID-19
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : August 18, 2024
Estimated Study Completion Date : February 17, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. spirometry [ Time Frame: 3 years ]
    FEV1 and FVC

  2. Lung volume [ Time Frame: 3 years ]
    Litres

  3. 6 minute walk distance [ Time Frame: 3 years ]
    meters


Secondary Outcome Measures :
  1. quality of life by SF36 questionnaire [ Time Frame: 3 years ]
    scores in all domains

  2. serology and T cell response [ Time Frame: 3 years ]
    titers


Biospecimen Retention:   Samples Without DNA
Blood will be taken for serology testing and T cell response after discharge, 6, 12, 18 and 24 months.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Exclusion Criteria: Unwilling to be follow up

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611243


Contacts
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Contact: Susanna Ng, MBChB 85235053128 drsssng@gmail.com
Contact: Karen Yiu, BSc 85235053532 ysyiu@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Susanna So-Shan Ng    3505 2785    drsssng123@yahoo.com.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
The University of Hong Kong
Health and Medical Research Fund
Investigators
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Principal Investigator: David S Hui, MD Chinese University of Hong Kong
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Prof David Shu Cheong Hui, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04611243    
Other Study ID Numbers: 2020.229
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: data pending

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs