NCT05373459

Brief Summary

A new wave of COVID-19 infections, mainly caused by the Omicron/ Delta variant, has been sweeping the globe since the start of 2022. In response, the administration of a third dose of COVID-19 vaccine was considered to address potential waning immunity over time and reduced effectiveness against the Omicron/ Delta variant. The pandemic also resulted in many infections among health care workers (HCWs) and their households. In this study, a retrospective analysis would perform on risk of COVID-19 infection and their outcome in relation to their COVID-19 vaccination history by using the data repository from one of the Hong Kong private hospitals. HCWs were required to submit a standardized online self-declaration form for report of 1) demographic of the HCWs, 2) symptoms related history and 3) COVID-19 exposure history once they were COVID-19 confirmed by rapid antigen test against COVID-19 and/or polymerase chain reaction (PCR) test for COVID-19. Subsequent follow up such as contact tracing, COVID-19 PCR testing results of these HCWs and status of return to work were captured by the infection control team in a systematic manner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,167

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

May 12, 2022

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • COVID-19 Infection

    Number of participants with COVID-19 infected

    During 1 February - 31 March 2022

  • Number of days return to work after COVID-19 infection

    Number of days return to work after COVID-19 infection

    During 1 February - 31 March 2022

Study Arms (2)

Health care workers without third COVID-19 booster

Health care workers received less than 3 doses of COVID-19 vaccine

HCWs with third COVID-19 booster

Health care workers received at least 3 doses of COVID-19 vaccine

Biological: Third COVID-19 booster

Interventions

Third COVID-19 booster

HCWs with third COVID-19 booster

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All full time staff members of the private hospital

You may qualify if:

  • All full time staff members of the private hospital

You may not qualify if:

  • History of COVID-19 before 2022

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Sanatorium & Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

COVID-19 vaccine booster shot

Study Officials

  • Jonpaul Sze Tsing Zee, MBChB

    Hong Kong Sanatorium & Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Infectious Disease

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 13, 2022

Study Start

May 16, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations