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NCT Number: NCT04611243

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)

Recruiting

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Key information

Conditions

Lung Function COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Exercise Capacity Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Quality of Life RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Susanna So-Shan Ng

CONTACT

[email protected]

3505 2785

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Unwilling to be follow up

-

Treatment and study plan

third dose vaccination with CoronaVac vaccine

Biological

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

Biological

Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine

Vaccination with Coronavac vaccine

Biological

Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart

Vaccination with BionTech Vaccine

Biological

Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Yiu, BSc

CONTACT

[email protected]

85235053532

Susanna Ng, MBChB

CONTACT

[email protected]

85235053128

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

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

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Nov 2, 2020
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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