NCT07154212

Brief 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 corticosteroids for coronavirus disease 2019 (COVID-19).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,793

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

September 2, 2025

Last Update Submit

September 2, 2025

Conditions

COVID-19 PneumoniaHypoxemiaHepatitis B

Outcome Measures

Primary Outcomes (2)

  • HBV reactivation

    number (%) of patients with HBV reactivation

    at least 3 months post treatment with corticosteroids

  • number (%) of patients with HBV reactivation

    one year

Study Arms (1)

Hepatitis B virus infected patients receiving corticosteroids for COVID-19 pneumonia

Diagnostic Test: Hepatitis B virus infection

Interventions

Hepatitis B virus infectionDIAGNOSTIC_TEST

anti-hepatitis B virus core antigen positive serologic status

Hepatitis B virus infected patients receiving corticosteroids for COVID-19 pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients hospitalized and treated with corticosteroids for covid-19

You may qualify if:

  • 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

You may not qualify if:

  • age under 18 years
  • hospitalized for medical conditions unrelated to COVID-19
  • received corticosteroid therapy for non-COVID-19 reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

HypoxiaHepatitis B

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

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

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 4, 2025

Study Start

November 1, 2020

Primary Completion

April 8, 2022

Study Completion

April 8, 2022

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

All anonymous data generated or analyzed during this study are available from the corresponding author upon reasonable request.

Locations

SL(1)