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

Recruiting

• Conditions: COVID-19 Infection; Chronic Hepatitis B
• Interventions: Drug: nucleoside analogues; Drug: Interferon

• Registration Number: NCT05792878
• Lead Sponsor: Beijing Ditan Hospital

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.

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nucleoside analogues treatment group	nucleoside analogues	Patients with chronic hepatitis B who received antiviral treatment with nucleoside analogues at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled
Interferon treatment group	Interferon	Patients with chronic hepatitis B who received antiviral treatment with Interferon at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled.

Primary Outcome Measures

Name	Time	Method
The rate of COVID-19 infection.	48 weeks after therapy	The rate of chronic hepatitis B patients infected with COVID-19 after initial antiviral treatment.

Secondary Outcome Measures

Name	Time	Method
The rate of severe disease after COVID-19 infection.	48 weeks after therapy	The 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 therapy	The hospitalization rate and duration of COVID-19 for chronic hepatitis B patients after initial antiviral treatment.

Trial Locations

Locations (1)

Department of Hepatology Division 2, Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China