Clinical trial NCT05792878: Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
Official title: The Observational Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
COVID-19 Infection
Keywords: chronic hepatitis
COVID-19 infection
interferon
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: During 48 weeks of the prospective observation period, the treated patients continuously use the original treatment. After the initial treatment patients are enrolled, they receive antiviral treatment with interferon or nucleoside analogues according to the needs of the disease. During the treatment period, the corresponding virology, serology, clinical biochemistry and liver imaging examinations of hepatitis B antiviral treatment were carried out every 3-6 months.

During COVID-19 infection, the patient shall be checked for clinical symptoms, clinical biochemistry, blood routine, pulmonary imaging, COVID-19 and antibodies, as well as other organs and functional indicators required by clinical needs.

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.

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.

Primary outcomes:
measure: The rate of COVID-19 infection.
timeFrame: 48 weeks after therapy
Secondary outcomes:
measure: The rate of severe disease after COVID-19 infection.
timeFrame: 48 weeks after therapy
measure: The hospitalization rate and duration of COVID-19.
timeFrame: 48 weeks after therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hepatology Division 2, Beijing Ditan Hospital
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital
name: Yao Xie, Doctor
role: PRINCIPAL_INVESTIGATOR
References: