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Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy

The Observational Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05792878
Enrollment
600
Registered
2023-03-31
Start date
2022-09-01
Completion date
2023-12-01
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B, COVID-19 Infection

Keywords

chronic hepatitis, COVID-19 infection, interferon

Brief summary

This is a two-way (retrospective and prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on HBV virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti-HBV treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti-HBV treatment on COVID-19 infection, its pathogenesis and prognosis were studied.

Detailed description

This is a two-way (retrospective+prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on hepatitis B virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti hepatitis B virus treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti hepatitis B virus treatment on COVID-19 infection, its pathogenesis and prognosis were explored.

Interventions

The naive treated patients with chronic hepatitis B were given antiviral treatment with interferon according to their condition.

The naive treated patients with chronic hepatitis B were given antiviral treatment with nucleoside analogues according to their condition.

Sponsors

Beijing Ditan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 1\) HBsAg positive for 6 months. * 2\) Patients undergoing initial or ongoing antiviral treatment. * 3\) HBeAg status and HBV DNA level are not limited.

Exclusion criteria

* 1\) Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis. * 2\) At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc. - 3) Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.

Design outcomes

Primary

MeasureTime frameDescription
The rate of COVID-19 infection.48 weeks after therapyThe rate of chronic hepatitis B patients infected with COVID-19 after initial antiviral treatment.

Secondary

MeasureTime frameDescription
The rate of severe disease after COVID-19 infection.48 weeks after therapyThe rate of severe disease after COVID-19 infection for chronic hepatitis B patients after initial antiviral treatment.
The hospitalization rate and duration of COVID-19.48 weeks after therapyThe hospitalization rate and duration of COVID-19 for chronic hepatitis B patients after initial antiviral treatment.

Countries

China

Contacts

Primary ContactYao Xie, Doctor
xieyao00120184@sina.com8610-84322200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026