Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101)

NCT ID: NCT04883177

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2022-05-01

Brief Summary

COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver disease are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. Therefore, early inoculation of SARS-CoV-2 vaccine in patients with liver disease is an important protective measure. However, information on the effectiveness and safety of the COVID-19 vaccine for liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Detailed Description

Patients with liver disease, especially liver cirrhosis, hepatobiliary malignancies, candidates for liver transplantation, and individuals who are immunosuppressed after liver transplantation, have an increased risk of COVID-19 infection and increased mortality. Therefore, early inoculation of SARS-CoV-2 vaccine in liver disease patients is an important protective measure. A small number of SARS-CoV-2 vaccines have been tested in clinical trials in healthy individuals and have evidence of short-term safety, immunogenicity and efficacy. However, information on the effectiveness and safety of the COVID-19 vaccine for patients with liver disease remains to be determined. This muilticentre study (CHESS2101) aims to study the effectiveness and safety of the COVID-19 vaccination for patients with liver disease.

Conditions

COVID-19; Liver Disease; Vaccine Reaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver disease, cirrhosis, liver cancer, liver transplant subjects, etc.;

2. Receiving the whole-course COVID-19 vaccination for 14 days or more;

3. Volunteer to participate in this study.

Exclusion Criteria

1. Younger than 18 years old;

2. Women during pregnancy or lactation;

3. Research on other situations deemed unsuitable for selection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

The Sixth People's Hospital of Shenyang City

UNKNOWN

Sponsor Role: collaborator

Xingtai City People's Hospital

UNKNOWN

Sponsor Role: collaborator

Jinchang Central Hospital

UNKNOWN

Sponsor Role: collaborator

Baoding People's Hospital

UNKNOWN

Sponsor Role: collaborator

The Third People's Hospital of Zhenjiang City

UNKNOWN

Sponsor Role: collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role: collaborator

Wuhan Jinyintan Hospital

UNKNOWN

Sponsor Role: collaborator

Jincheng People's Hospital

OTHER

Sponsor Role: collaborator

The Third People's Hospital of Tibet Autonomous Region

UNKNOWN

Sponsor Role: collaborator

People's Hospital of Ningxia Hui Autonomous Region

OTHER

Sponsor Role: collaborator

Fuling Central Hospital of Chongqing City

OTHER

Sponsor Role: collaborator

Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region

UNKNOWN

Sponsor Role: collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role: collaborator

The Third People's Hospital of Linfen City

UNKNOWN

Sponsor Role: collaborator

Yibin First People's Hospital

UNKNOWN

Sponsor Role: collaborator

Jingzhou Central Hospital

OTHER

Sponsor Role: collaborator

Wuxi Fifth People's Hospital

UNKNOWN

Sponsor Role: collaborator

Qingyang People's Hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role: collaborator

Beilun Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Qingdao Sixth People's Hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Beijing YouAn Hospital

OTHER

Sponsor Role: collaborator

The First People's Hospital of Taicang

UNKNOWN

Sponsor Role: collaborator

The Third People's Hospital of Taiyuan

OTHER

Sponsor Role: collaborator

Tianjin Second People's Hospital

OTHER

Sponsor Role: collaborator

Tianjin Third Central Hospital

OTHER

Sponsor Role: collaborator

Qishan Hospital of Yantai City

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of Yunnan University

OTHER

Sponsor Role: collaborator

The First People's Hospital of Yunnan

OTHER

Sponsor Role: collaborator

The Fourth Affiliated Hospital of Zhejiang University

UNKNOWN

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Qi

Chief, CHESS Center, Institute of Portal Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaolong Qi, MD

Role: STUDY_CHAIR

LanZhou University

Wenhong Zhang, MD

Role: STUDY_CHAIR

Huashan Hospital

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing You'an Hospital

Beijing, Beijing Municipality, China

Chongqing Fuling Central Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Jinchang Central Hospital

Jinchang, Gansu, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Qingyang People's Hospital

Qingyang, Gansu, China

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Xingtai People's Hospital

Xingtai, Hebei, China

Baoding People's Hospital

Baoding, Heibei, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Wuhan Jinyintan Hospital

Wuhan, Hubei, China

The First People's Hospital of Taicang

Taicang, Jiangsu, China

Wuxi Fifth People's Hospital

Wuxi, Jiangsu, China

The Affiliated Third Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Jinzhou Central Hospital

Jinzhou, Liaoning, China

Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Shandong Provincial Hospital

Jinan, Shandong, China

Qingdao Sixth People's Hospital

Qingdao, Shandong, China

Qishan Hospital of Yantai City

Yantai, Shandong, China

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Jincheng People's Hospital

Jincheng, Shanxi, China

The Third People's Hospital of Linfen City

Linfen, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Taiyuan Third People's Hospital

Taiyuan, Shanxi, China

Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region

Chengdu, Sichuan, China

Yibin First People's Hospital

Yibin, Sichuan, China

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

The Third People's Hospital of Tibet Autonomous Region

Lhasa, Tibet, China

Affiliated Hospital of Yunnan University

Kunming, Yunnan, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

The Central Hospital of Lishui City

Lishui, Zhejiang, China

Beilun Hospital of Traditional Chinese Medicine

Ningbo, Zhejiang, China

The Fourth Affiliated Hospital of Zhejiang University

Yiwu, Zhejiang, China

Countries

China

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Other Identifiers

CHESS2101

Identifier Type: -

Identifier Source: org_study_id