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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04611243
Other study ID # 2020.229
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 22, 2020
Est. completion date February 17, 2025

Study information

Verified date February 2023
Source Chinese University of Hong Kong
Contact Susanna Ng, MBChB
Phone 85235053128
Email drsssng@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date February 17, 2025
Est. primary completion date August 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients who have been discharged from hospital following treatment for COVID-19 - Exclusion Criteria: Unwilling to be follow up -

Study Design


Intervention

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
Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine
Vaccination with Coronavac vaccine
Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart
Vaccination with BionTech Vaccine
Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart

Locations

Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
Chinese University of Hong Kong Health and Medical Research Fund, The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary spirometry FEV1 and FVC 3 years
Primary Lung volume Litres 3 years
Primary 6 minute walk distance meters 3 years
Secondary quality of life by SF36 questionnaire scores in all domains 3 years
Secondary serology and T cell response titers 3 years
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