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

NCT ID: NCT04611243

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-22

Study Completion Date

2026-02-17

Brief Summary

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(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

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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.

Conditions

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Lung Function Exercise Capacity Quality of Life Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID survivors

No interventions assigned to this group

Vaccination with CoronaVac vaccine

Vaccination with Coronavac vaccine

Intervention Type BIOLOGICAL

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

Vaccination with BionTech vaccine

Vaccination with BionTech Vaccine

Intervention Type BIOLOGICAL

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).

third dose vaccination with CoronaVac vaccine

Intervention Type 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

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).

third dose vaccination with BionTech vaccine

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Vaccination with Coronavac vaccine

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

Intervention Type BIOLOGICAL

Vaccination with BionTech Vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

Health and Medical Research Fund

OTHER_GOV

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Prof David Shu Cheong Hui

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Hui, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Susanna Ng, MBChB

Role: CONTACT

85235053128

Karen Yiu, BSc

Role: CONTACT

85235053532

Facility Contacts

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Susanna So-Shan Ng

Role: primary

3505 2785

References

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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.

Reference Type DERIVED
PMID: 37964259 (View on PubMed)

Other Identifiers

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2020.229

Identifier Type: -

Identifier Source: org_study_id

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