NCT05470894

Brief Summary

The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is still raging across the world and vaccination is expected to lead us out of this pandemic. Although the efficacy of these vaccines is beyond doubt, safety still remains a concern. Liver injury, such as autoimmune hepatitis (AIH), has been reported after COVID-19 vaccination. The aim of this prospective study is to investigate the spectrum and profile of liver injury after COVID-19 vaccination in Asia-Pacific region and to explore the potential risk factors for the development of liver injury.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

July 21, 2022

Last Update Submit

March 21, 2025

Conditions

Subjects After COVID-19 Vaccination

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with liver injury after COVID-19 vaccination

    The COVID-19 vaccine-related liver injury (such as elevated liver enzymes, total bilirubin, etc.) was recorded and its spectrum and profile were evaluated.

    Within 24 weeks after COVID-19 vaccination

Study Arms (1)

COVID-19 Vaccination Group

Subjects who have received at lease one dose of approved COVID-19 vaccine

Biological: Approved COVID-19 vaccine

Interventions

Approved COVID-19 vaccineBIOLOGICAL

Vaccination for COVI9-19

COVID-19 Vaccination Group

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects after COVID-19 vaccination

You may qualify if:

  • Subjects who have received at least one dose of approved COVID-19 vaccine;
  • Volunteer to participate in this study.

You may not qualify if:

  • No valid consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Humanity & Health Medical Group Limited

Hong Kong, Hong Kong

Location

Nihon University School of Medicine

Tokyo, Japan

Location

Tokyo University

Tokyo, Japan

Location

Study Officials

  • George Lau, MD

    Humanity & Health Medical Group

    PRINCIPAL INVESTIGATOR

  • Masao Omata, MD, PhD

    Tokyo University

    PRINCIPAL INVESTIGATOR

  • Tatsuo Kanda, MD, PhD

    Nihon University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 22, 2022

Study Start

September 5, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations

HK(1)JP(2)