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

This is a two-way (retrospective and prospective) study of COVID-19 infection in anobservational cohort of patients with chronic hepatitis B treated with antiviral therapy.Patients with chronic hepatitis B who received anti-HBV treatment in the SecondDepartment of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical Universityfrom February 2022 to December 2023 were enrolled. After enrollment, demographic data ofpatients, information on antiviral treatment of chronic hepatitis B, COVID-19vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 topre enrollment, and data on HBV virus and serology, clinical biochemistry, liver and lungimaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients werecollected. After enrollment, prospective anti-HBV treatment, HBV virology, clinicalbiochemistry, liver imaging and COVID-19 infection and morbidity were observed. Thepatients with COVID-19 infection during the prospective observation period were observedfor COVID-19 infection, onset and treatment, including body temperature, clinicalsymptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry,disease severity, time of virus negative conversion, hospital stay and outcome. Theinfluence of COVID-19 infection on liver disease and the influence of interferon anti-HBVtreatment 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.

Recruiting
Chronic Hepatitis B
Covid-19 Infection

Drug: Interferon

The naive treated patients with chronic hepatitis B were given antiviral treatment with
interferon according to their condition.
Other Name: peg-interferon alpha

Drug: nucleoside analogues

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 70 Years
Countries
China
Locations

Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing, China

Investigator: Yao Xie, Doctor
Contact: 8610-84322200
xieyao00120184@sina.com

Contacts

Yao Xie, Doctor
8610-84322200
xieyao00120184@sina.com

Yao Xie, Doctor, Principal Investigator
Beijing Ditan Hospital

Beijing Ditan Hospital
NCT Number
Keywords
chronic hepatitis
COVID-19 infection
Interferon
MeSH Terms
Infections
Communicable Diseases
COVID-19
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Interferons
Interferon-alpha