COVID-19 PneumoniaHBV-C19NCT07154212
Hepatitis B Virus Reactivation in COVID-19
An observational study of COVID-19 Pneumonia and Hypoxemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The aim of this observational cohort study was to evaluate adherence to hepatitis B virus (HBV) screening guidelines in a country characterized by low HBV prevalence and assess the potential reactivation and progression of HBV infection in anti-HBV core antigen antibodies (anti-HBc) positive patients receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Hypoxemia, Hepatitis B
- What is being tested?
- Hepatitis B virus infection
- How many people
- 1,793 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Nov 2020to 8 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized and treated with corticosteroids for covid-19
Who may be able to join
- hospitalized adult patients with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ribonucleic acid (RNA) polymerase chain reaction (PCR) test
- supplemental oxygen
- treated with corticosteroids for COVID-19 pneumonia
Who cannot join
- age under 18 years
- hospitalized for medical conditions unrelated to COVID-19
- received corticosteroid therapy for non-COVID-19 reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing the Risk of Hepatitis B Virus Reactivation in COVID-19 Patients Treated With Corticosteroids
The aim of this observational cohort study was to evaluate adherence to hepatitis B virus (HBV) screening guidelines in a country characterized by low HBV prevalence and assess the potential reactivation and progression of HBV infection in anti-HBV core antigen antibodies (anti-HBc) positive patients receiving corticosteroids for coronavirus disease 2019 (COVID-19).
- Conditions
- COVID-19 Pneumonia, Hypoxemia, Hepatitis B
- Being tested
- Hepatitis B virus infection
- Medical subject headings
- Hypoxia, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B virus infectionDiagnostic test
anti-hepatitis B virus core antigen positive serologic status
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B virus infected patients receiving corticosteroids for COVID-19 pneumonia | Not described Receives: Diagnostic Test: Hepatitis B virus infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV reactivation
number (%) of patients with HBV reactivation
Measured: at least 3 months post treatment with corticosteroids
number (%) of patients with HBV reactivation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Nov 2020
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,793 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154212
- Sponsor's protocol ID
- HBV in covid
- Acronym
- HBV-C19
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymous data generated or analyzed during this study are available from the corresponding author upon reasonable request.
Publications
Stupica D, Collinet-Adler S, Grasic JJ, Jurisevic D, Kejzar N, Poljak M, Stamol T. The risk of hepatitis B virus reactivation in COVID-19 patients treated with corticosteroids: a retrospective observational cohort study. BMC Infect Dis. 2026 Jan 20;26(1):352. doi: 10.1186/s12879-026-12610-5.
PubMed 41559625
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing the Risk of Hepatitis B Virus Reactivation in COVID-19 Patients Treated With Corticosteroids
- ClinicalTrials.gov ID
- NCT07154212
- Acronym / sponsor ID
- HBV-C19 / HBV in covid
- Conditions
- COVID-19 Pneumonia, Hypoxemia, Hepatitis B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,793 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 4 Sep 2025 (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 aim of this observational cohort study was to evaluate adherence to hepatitis B virus (HBV) screening guidelines in a country characterized by low HBV prevalence and assess the potential reactivation and progression of HBV infection in anti-HBV core antigen antibodies (anti-HBc) positive patients receiving corticosteroids for coronavirus disease 2019 (COVID-19).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B virus infected patients receiving corticosteroids for COVID-19 pneumonia | – | Diagnostic Test: Hepatitis B virus infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized and treated with corticosteroids for covid-19
Key inclusion criteria (3 listed)
- hospitalized adult patients with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ribonucleic acid (RNA) polymerase chain reaction (PCR) test
- supplemental oxygen
- treated with corticosteroids for COVID-19 pneumonia
Key exclusion criteria (3 listed)
- age under 18 years
- hospitalized for medical conditions unrelated to COVID-19
- received corticosteroid therapy for non-COVID-19 reasons
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 |
|---|---|---|
| Hepatitis B virus infectionanti-hepatitis B virus core antigen positive serologic status | Diagnostic test | Hepatitis B virus infected patients receiving corticosteroids for COVID-19 pneumonia |
Primary outcome
HBV reactivation
Time frame: at least 3 months post treatment with corticosteroids
number (%) of patients with HBV reactivation
number (%) of patients with HBV reactivation
Time frame: one year
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 4 Sep 2025.
- Derived from this study: PubMed 41559625Stupica D, Collinet-Adler S, Grasic JJ, Jurisevic D, Kejzar N, Poljak M, Stamol T. The risk of hepatitis B virus reactivation in COVID-19 patients treated with corticosteroids: a retrospective observational cohort study. BMC Infect Dis. 2026 Jan 20;26(1):352. doi: 10.1186/s12879-026-12610-5.
- Individual participant dataSharing planned: Yes. All anonymous data generated or analyzed during this study are available from the corresponding author upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Hypoxemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 3 inclusion and 3 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
HBV reactivation (time frame: at least 3 months post treatment with corticosteroids). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07154212, which also lists 1 linked publication.
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 4 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.