COVID-19 Vaccines in Patients With Chronic Liver Disease

Beijing 302 Hospital

Status

Enrolling

Conditions

Liver Disease Chronic

Treatments

Biological: COVID-19 Vaccines

Study type

Interventional

Funder types

Other

Identifiers

NCT05017805

ky-2021-7-8-1

Details and patient eligibility

About

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.

Full description

This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years.
Serum ALT and AST are both ≤ 80 U/L.
HIV and TPHA screening were negative.
Body temperature ≤37.0℃.

Exclusion criteria

Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B scan).
Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
Patients with cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.c.
Patients with urticaria within a year.
Patients with coagulation disorder.
Faintng during acupuncture treatment .
Patients who received other investigational drugs within one month.
Be receiving anti-TB treatment.
Other conditions determined by the researcher.