Subjects After COVID-19 VaccinationNCT05470894
Liver Injury After COVID-19 Vaccination
An observational study of Subjects After COVID-19 Vaccination, run by Humanity & Health Medical Group Limited at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects After COVID-19 Vaccination
- What is being tested?
- Approved COVID-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 379 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 5 Sep 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects after COVID-19 vaccination
Who may be able to join
- Subjects who have received at least one dose of approved COVID-19 vaccine;
- Volunteer to participate in this study.
Who cannot join
- No valid consent.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)
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
- Being tested
- Approved COVID-19 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approved COVID-19 vaccineBiological
Vaccination for COVI9-19
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Vaccination Group | Subjects who have received at lease one dose of approved COVID-19 vaccine Receives: Biological: Approved COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 weeks after COVID-19 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start5 Sep 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects After COVID-19 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity & Health Medical Group Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo University, Nihon University School of Medicine
- Responsible party
- Sponsor
- Investigators
- George Lau, MD, Principal investigator, Humanity & Health Medical GroupMasao Omata, MD, PhD, Principal investigator, Tokyo UniversityTatsuo Kanda, MD, PhD, Principal investigator, Nihon University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470894
- Sponsor's protocol ID
- APCOVLI-2022-01
- Status last verified
- Mar 2025
- First submitted
- 21 Jul 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APASL Post-COVID-19 Vaccination Liver Injury (APCOVLI Study)
- ClinicalTrials.gov ID
- NCT05470894
- Acronym / sponsor ID
- APCOVLI-2022-01
- Conditions
- Subjects After COVID-19 Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Humanity & Health Medical Group LimitedUniversity, hospital or other
- Collaborators
- Tokyo University, Nihon University School of Medicine
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Vaccination Group | – | Biological: Approved COVID-19 vaccineSubjects who have received at lease one dose of approved COVID-19 vaccine |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects after COVID-19 vaccination
Key inclusion criteria (2 listed)
- Subjects who have received at least one dose of approved COVID-19 vaccine;
- Volunteer to participate in this study.
Key exclusion criteria (1 listed)
- No valid consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Approved COVID-19 vaccineVaccination for COVI9-19 | Biological | COVID-19 Vaccination Group |
Primary outcome
Number of subjects with liver injury after COVID-19 vaccination
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Lau, MD principal investigator
Humanity & Health Medical Group
Masao Omata, MD, PhD principal investigator
Tokyo University
Tatsuo Kanda, MD, PhD principal investigator
Nihon University School of Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects After COVID-19 Vaccination, run by Humanity & Health Medical Group Limited at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with liver injury after COVID-19 vaccination (time frame: Within 24 weeks after COVID-19 vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.