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

NCT04611243 | Recruiting DMC

• 1 other identifier: 2020.229
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

(a) Objectives

1. 1.To assess the full lung function, exercise capacity, quality of life in patients with COVID-19 over 2 years.
2. 2.To assess the longevity of the serology response to SARS-CoV2.
3. 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. 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. 5.To assess the third booster dose for subjects who have poor antibody response despite having received two doses of CoronaVac (Sinovac)

Conditions

Lung Function; Exercise Capacity; Quality of Life; Covid19

Outcome Measures

Primary Outcomes (3)

• spirometry

  FEV1 and FVC

  3 years

• Lung volume

  Litres

  3 years

• 6 minute walk distance

  meters

  3 years

Secondary Outcomes (2)

• quality of life by SF36 questionnaire

  3 years

• serology and T cell response

  3 years

Study Arms (5)

COVID survivors

Vaccination with CoronaVac vaccine

Biological: Vaccination with Coronavac vaccine

Vaccination with BionTech vaccine

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).

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).

Biological: third dose vaccination with BionTech vaccine

Interventions

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 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

third dose vaccination with BionTech vaccine

Vaccination with Coronavac vaccine BIOLOGICAL

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

Vaccination with CoronaVac vaccine

Vaccination with BionTech Vaccine BIOLOGICAL

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

Vaccination with BionTech vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The University of Hong Kong: collaborator
• Health and Medical Research Fund: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be taken for serology testing and T cell response after discharge, 6, 12, 18 and 24 months.

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine; Vaccination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• David S Hui, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna Ng, MBChB

CONTACT

85235053128; drsssng@gmail.com

Karen Yiu, BSc

CONTACT

85235053532; ysyiu@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: November 2, 2020
• Study Start: May 22, 2020
• Primary Completion: August 18, 2025
• Study Completion: February 17, 2026
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

HK (1)