NCT05470894

Liver Injury After COVID-19 Vaccination

APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 379 (actual)
• Sponsor: Humanity & Health Medical Group Limited · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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.

Conditions

• Subjects After COVID-19 Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Approved COVID-19 vaccine	Vaccination for COVI9-19

Timeline

• Start date: 2022-09-05
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-07-22
• Last updated: 2025-03-24

Locations

3 sites across 2 countries: Hong Kong, Japan

Regulatory

• FDA-regulated drug study