COVID-19 Vaccines in Patients With Chronic Liver Disease

Last updated: April 17, 2022
Sponsor: Beijing 302 Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT05017805
ky-2021-7-8-1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/Bscan).
  • Patients who are allergic to any component of the vaccine, or have a serious historyof 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 duringthe progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquiredangioedema / 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.

Study Design

Total Participants: 300
Study Start date:
August 15, 2021
Estimated Completion Date:
August 15, 2025

Study 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.

Connect with a study center

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing 100039
    China

    Active - Recruiting

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