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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04883177
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : May 12, 2021
Sponsor:
Collaborators:
LanZhou University
Huashan Hospital
The Sixth People's Hospital of Shenyang City
Xingtai City People's Hospital
Jinchang Central Hospital
Baoding People's Hospital
The Third People's Hospital of Zhenjiang City
Shanxi Bethune Hospital
Wuhan Jinyintan Hospital
Jincheng People's Hospital
The Third People's Hospital of Tibet Autonomous Region
People's Hospital of Ningxia Hui Autonomous Region
Fuling Central Hospital of Chongqing City
Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
The Central Hospital of Lishui City
The Third People's Hospital of Linfen City
Yibin First People's Hospital
Jingzhou Central Hospital
Wuxi Fifth People's Hospital
Qingyang People's Hospital
The First Affiliated Hospital of Anhui Medical University
Beilun Hospital of Traditional Chinese Medicine
Henan Provincial People's Hospital
Qingdao Sixth People's Hospital
The First Affiliated Hospital of Xiamen University
Shandong Provincial Hospital
Beijing YouAn Hospital
The First People's Hospital of Taicang
Taiyuan Third People's Hospital
Tianjin Second People's Hospital
Tianjin Third Central Hospital
Qishan Hospital of Yantai City
Affiliated Hospital of Yunnan University
The First People's Hospital of Yunnan
The Fourth Affiliated Hospital of Zhejiang University
Third Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Chongqing Medical University
Information provided by (Responsible Party):
Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

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.

Condition or disease
COVID-19 Liver Disease Vaccine Reaction

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101): a Multicenter Cohort Study
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : May 10, 2023
Estimated Study Completion Date : May 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases




Primary Outcome Measures :
  1. Number of participants with adverse events within 7 days after each injection [ Time Frame: up to 7 days after each injection ]

Secondary Outcome Measures :
  1. Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0 [ Time Frame: up to 28 days after each injection ]
  2. Antibody serological conversion rate in populations with liver disease after COVID-19 vaccination [ Time Frame: 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 ]
  3. Neutralizing antibody titers in blood samples after vaccination [ Time Frame: 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 ]
  4. Antibody IgM titers in blood samples after vaccination [ Time Frame: 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 ]
  5. Antibody IgG titers in blood samples after vaccination [ Time Frame: 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Populations With Liver Disease who Complete the whole-course COVID-19 vaccination
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04883177


Contacts
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Contact: Jitao Wang, MD +8618632957579 wangjt302@163.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
LanZhou University
Huashan Hospital
The Sixth People's Hospital of Shenyang City
Xingtai City People's Hospital
Jinchang Central Hospital
Baoding People's Hospital
The Third People's Hospital of Zhenjiang City
Shanxi Bethune Hospital
Wuhan Jinyintan Hospital
Jincheng People's Hospital
The Third People's Hospital of Tibet Autonomous Region
People's Hospital of Ningxia Hui Autonomous Region
Fuling Central Hospital of Chongqing City
Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
The Central Hospital of Lishui City
The Third People's Hospital of Linfen City
Yibin First People's Hospital
Jingzhou Central Hospital
Wuxi Fifth People's Hospital
Qingyang People's Hospital
The First Affiliated Hospital of Anhui Medical University
Beilun Hospital of Traditional Chinese Medicine
Henan Provincial People's Hospital
Qingdao Sixth People's Hospital
The First Affiliated Hospital of Xiamen University
Shandong Provincial Hospital
Beijing YouAn Hospital
The First People's Hospital of Taicang
Taiyuan Third People's Hospital
Tianjin Second People's Hospital
Tianjin Third Central Hospital
Qishan Hospital of Yantai City
Affiliated Hospital of Yunnan University
The First People's Hospital of Yunnan
The Fourth Affiliated Hospital of Zhejiang University
Third Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital of Chongqing Medical University
Investigators
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Study Chair: Xiaolong Qi, MD LanZhou University
Study Chair: Wenhong Zhang, MD Huashan Hospital
Publications:
World Health Organization. Coronavirus disease (COVID-2019) situation reports[EB/OL]. https: //www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/.
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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Responsible Party: Xiaolong Qi, Chief, CHESS Center, Institute of Portal Hypertension, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT04883177    
Other Study ID Numbers: CHESS2101
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases