Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05792878 |
| Other study ID # |
DTXY26 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Beijing Ditan Hospital |
| Contact |
Yao Xie, Doctor |
| Phone |
8610-84322200 |
| Email |
xieyao00120184[@]sina.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
