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Recruiting NCT04611243

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

— Observational Lung Function Exercise Capacity Quality of Life Covid19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: third dose vaccination with CoronaVac vaccine, third dose vaccination with BionTech vaccine, Vaccination with Coronavac vaccine, Vaccination with BionTech Vaccine.
Who it may be relevant to
Registry conditions: Lung Function, Exercise Capacity, Quality of Life, Covid19. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

(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.

Interventions

  • 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

Primary outcome measures

  • spirometry [Time frame: 3 years]
  • Lung volume [Time frame: 3 years]
  • 6 minute walk distance [Time frame: 3 years]
Secondary outcome measures (2)
  • quality of life by SF36 questionnaire [Time frame: 3 years]
  • serology and T cell response [Time frame: 3 years]

Eligibility criteria

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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Hong Kong

Publications

  • Chan KKP, Ng SSS, Lui GCY, Leung HS, Wong KT, Chu WCW, Chan TO, Yiu KYS, Tso EYK, To KW, Ngai JCL, Yip TWH, Lo RLP, Ng JKC, Ko FWS, Hui DSC. Comparison of the 12-month impact of COVID-19 and SARS on physiological capacity and health-related quality of life. BMC Pulm Med. 2023 Nov 14;23(1):441. doi: 10.1186/s12890-023-02750-8. PMID 37964259

Identifiers

NCT: NCT04611243 · 2020.229

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗