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

NCT04883177 | Completed DMC

• 1 other identifier: CHESS2101
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 37

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.

Conditions

COVID-19; Liver Disease; Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events within 7 days after each injection

  up to 7 days after each injection

Secondary Outcomes (5)

• Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0

  up to 28 days after each injection

• Antibody serological conversion rate in populations with liver disease after COVID-19 vaccination

  the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination

• Neutralizing antibody titers in blood samples after vaccination

  the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination

• Antibody IgM titers in blood samples after vaccination

  the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination

• Antibody IgG titers in blood samples after vaccination

  the day of the first dose of vaccination (baseline) and 14 days, 28 days, 90 days, and 180 days after the second dose of vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Populations With Liver Disease who Complete the whole-course COVID-19 vaccination

You may qualify if:

• Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver disease, cirrhosis, liver cancer, liver transplant subjects, etc.;
• Receiving the whole-course COVID-19 vaccination for 14 days or more;
• Volunteer to participate in this study.

You may not qualify if:

• Younger than 18 years old;
• Women during pregnancy or lactation;
• Research on other situations deemed unsuitable for selection.

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• LanZhou University: collaborator
• Huashan Hospital: collaborator
• The Sixth People's Hospital of Shenyang City: collaborator
• Xingtai City People's Hospital: collaborator
• Jinchang Central Hospital: collaborator
• Baoding People's Hospital: collaborator
• The Third People's Hospital of Zhenjiang City: collaborator
• Shanxi Bethune Hospital: collaborator
• Wuhan Jinyintan Hospital: collaborator
• Jincheng People's Hospital: collaborator
• The Third People's Hospital of Tibet Autonomous Region: collaborator
• People's Hospital of Ningxia Hui Autonomous Region: collaborator
• Fuling Central Hospital of Chongqing City: collaborator
• Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region: collaborator
• The Central Hospital of Lishui City: collaborator
• The Third People's Hospital of Linfen City: collaborator
• Yibin First People's Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• Wuxi Fifth People's Hospital: collaborator
• Qingyang People's Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Beilun Hospital of Traditional Chinese Medicine: collaborator
• Henan Provincial People's Hospital: collaborator
• Qingdao Sixth People's Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Shandong Provincial Hospital: collaborator
• Beijing YouAn Hospital: collaborator
• The First People's Hospital of Taicang: collaborator
• The Third People's Hospital of Taiyuan: collaborator
• Tianjin Second People's Hospital: collaborator
• Tianjin Third Central Hospital: collaborator
• Qishan Hospital of Yantai City: collaborator
• Affiliated Hospital of Yunnan University: collaborator
• The First People's Hospital of Yunnan: collaborator
• The Fourth Affiliated Hospital of Zhejiang University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (37)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing You'an Hospital

Beijing, Beijing Municipality, China

Location

Chongqing Fuling Central Hospital

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Jinchang Central Hospital

Jinchang, Gansu, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Qingyang People's Hospital

Qingyang, Gansu, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Xingtai People's Hospital

Xingtai, Hebei, China

Location

Baoding People's Hospital

Baoding, Heibei, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

Wuhan Jinyintan Hospital

Wuhan, Hubei, China

Location

The First People's Hospital of Taicang

Taicang, Jiangsu, China

Location

Wuxi Fifth People's Hospital

Wuxi, Jiangsu, China

Location

The Affiliated Third Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

Jinzhou Central Hospital

Jinzhou, Liaoning, China

Location

Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Qingdao Sixth People's Hospital

Qingdao, Shandong, China

Location

Qishan Hospital of Yantai City

Yantai, Shandong, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Jincheng People's Hospital

Jincheng, Shanxi, China

Location

The Third People's Hospital of Linfen City

Linfen, Shanxi, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Location

Taiyuan Third People's Hospital

Taiyuan, Shanxi, China

Location

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

Chengdu, Sichuan, China

Location

Yibin First People's Hospital

Yibin, Sichuan, China

Location

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Location

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Location

The Third People's Hospital of Tibet Autonomous Region

Lhasa, Tibet, China

Location

Affiliated Hospital of Yunnan University

Kunming, Yunnan, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Location

The Central Hospital of Lishui City

Lishui, Zhejiang, China

Location

Beilun Hospital of Traditional Chinese Medicine

Ningbo, Zhejiang, China

Location

The Fourth Affiliated Hospital of Zhejiang University

Yiwu, Zhejiang, China

Location

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• World Health Organization. Coronavirus disease (COVID-2019) situation reports[EB/OL]. https: //www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/.

  BACKGROUND

• Sarin SK, Choudhury A, Lau GK, Zheng MH, Ji D, Abd-Elsalam S, Hwang J, Qi X, Cua IH, Suh JI, Park JG, Putcharoen O, Kaewdech A, Piratvisuth T, Treeprasertsuk S, Park S, Wejnaruemarn S, Payawal DA, Baatarkhuu O, Ahn SH, Yeo CD, Alonzo UR, Chinbayar T, Loho IM, Yokosuka O, Jafri W, Tan S, Soo LI, Tanwandee T, Gani R, Anand L, Esmail ES, Khalaf M, Alam S, Lin CY, Chuang WL, Soin AS, Garg HK, Kalista K, Batsukh B, Purnomo HD, Dara VP, Rathi P, Al Mahtab M, Shukla A, Sharma MK, Omata M; APASL COVID Task Force, APASL COVID Liver Injury Spectrum Study (APCOLIS Study-NCT 04345640). Pre-existing liver disease is associated with poor outcome in patients with SARS CoV2 infection; The APCOLIS Study (APASL COVID-19 Liver Injury Spectrum Study). Hepatol Int. 2020 Sep;14(5):690-700. doi: 10.1007/s12072-020-10072-8. Epub 2020 Jul 4.

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MeSH Terms

Conditions

COVID-19; Liver Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Digestive System Diseases

Study Officials

• Xiaolong Qi, MD

  LanZhou University

  STUDY CHAIR

• Wenhong Zhang, MD

  Huashan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, CHESS Center, Institute of Portal Hypertension

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 12, 2021
• Study Start: May 11, 2021
• Primary Completion: January 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (37)