Liver Injury After COVID-19 Vaccination
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 Vaccination Group Subjects who have received at lease one dose of approved COVID-19 vaccine |
Biological: Approved COVID-19 vaccine
Vaccination for COVI9-19
|
Outcome Measures
Primary Outcome Measures
- Number of subjects with liver injury after COVID-19 vaccination [Within 24 weeks 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects who have received at least one dose of approved COVID-19 vaccine;
-
Volunteer to participate in this study.
Exclusion Criteria:
- No valid consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Humanity & Health Medical Group Limited | Hong Kong | Hong Kong | ||
| 2 | Tokyo University | Tokyo | Japan |
Sponsors and Collaborators
- Humanity & Health Medical Group Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APCOVLI-2022-01