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

NCT ID: NCT05792878

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis B COVID-19 Infection

Keywords

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chronic hepatitis COVID-19 infection interferon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Interferon treatment group

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.

Interferon

Intervention Type DRUG

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

nucleoside analogues treatment group

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

nucleoside analogues

Intervention Type DRUG

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

Interventions

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Interferon

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

Intervention Type DRUG

nucleoside analogues

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

Intervention Type DRUG

Other Intervention Names

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peg-interferon alpha NAs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Ditan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yao Xie

Director of Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yao Xie, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

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Department of Hepatology Division 2, Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yao Xie, Doctor

Role: CONTACT

Phone: 8610-84322200

Email: [email protected]

Facility Contacts

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Yao Xie, Doctor

Role: primary

Other Identifiers

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DTXY26

Identifier Type: -

Identifier Source: org_study_id