Clinical trial NCT04883177: Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101)
Official title: Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101): a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Liver Disease
Vaccine Reaction
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Huashan Hospital
name: The Sixth People's Hospital of Shenyang City
name: Xingtai City People's Hospital
name: Jinchang Central Hospital
name: Baoding People's Hospital
name: The Third People's Hospital of Zhenjiang City
name: Shanxi Bethune Hospital
name: Wuhan Jinyintan Hospital
name: Jincheng People's Hospital
name: The Third People's Hospital of Tibet Autonomous Region
name: People's Hospital of Ningxia Hui Autonomous Region
name: Fuling Central Hospital of Chongqing City
name: Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
name: The Central Hospital of Lishui City
name: The Third People's Hospital of Linfen City
name: Yibin First People's Hospital
name: Jingzhou Central Hospital
name: Wuxi Fifth People's Hospital
name: Qingyang People's Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Beilun Hospital of Traditional Chinese Medicine
name: Henan Provincial People's Hospital
name: Qingdao Sixth People's Hospital
name: The First Affiliated Hospital of Xiamen University
name: Shandong Provincial Hospital
name: Beijing YouAn Hospital
name: The First People's Hospital of Taicang
name: The Third People's Hospital of Taiyuan
name: Tianjin Second People's Hospital
name: Tianjin Third Central Hospital
name: Qishan Hospital of Yantai City
name: Affiliated Hospital of Yunnan University
name: The First People's Hospital of Yunnan
name: The Fourth Affiliated Hospital of Zhejiang University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital of Chongqing Medical University
First posted: 2021-05-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Populations With Liver Disease who Complete the whole-course COVID-19 vaccination

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.

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.

Primary outcomes:
measure: Number of participants with adverse events within 7 days after each injection
timeFrame: up to 7 days after each injection
Secondary outcomes:
measure: Overall incidence of adverse reactions within 28 days as assessed by CTCAE v4.0
timeFrame: up to 28 days after each injection
measure: Antibody serological conversion rate in populations with liver disease after COVID-19 vaccination
timeFrame: 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
measure: Neutralizing antibody titers in blood samples after vaccination
timeFrame: 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
measure: Antibody IgM titers in blood samples after vaccination
timeFrame: 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
measure: Antibody IgG titers in blood samples after vaccination
timeFrame: 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
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing You'an Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Fuling Central Hospital
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Jinchang
country: China
facility: Jinchang Central Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Qingyang
country: China
facility: Qingyang People's Hospital
state: Gansu
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Baoding
country: China
facility: Baoding People's Hospital
state: Heibei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Jinyintan Hospital
state: Hubei
city: Taicang
country: China
facility: The First People's Hospital of Taicang
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Fifth People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Third Hospital of Jiangsu University
state: Jiangsu
city: Jinzhou
country: China
facility: Jinzhou Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: Sixth People's Hospital of Shenyang
state: Liaoning
city: Yinchuan
country: China
facility: People's Hospital of Ningxia Hui Autonomous Region
state: Ningxia Hui Autonomous Region
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Sixth People's Hospital
state: Shandong
city: Yantai
country: China
facility: Qishan Hospital of Yantai City
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
city: Jincheng
country: China
facility: Jincheng People's Hospital
state: Shanxi
city: Linfen
country: China
facility: The Third People's Hospital of Linfen City
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan Third People's Hospital
state: Shanxi
city: Chengdu
country: China
facility: Hospital of the Chengdu Office of the People's Government of Tibet Autonomous Region
state: Sichuan
city: Yibin
country: China
facility: Yibin First People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
city: Lasa
country: China
facility: The Third People's Hospital of Tibet Autonomous Region
state: Tibet
city: Kunming
country: China
facility: Affiliated Hospital of Yunnan University
state: Yunnan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Lishui
country: China
facility: The Central Hospital of Lishui City
state: Zhejiang
city: Ningbo
country: China
facility: Beilun Hospital of Traditional Chinese Medicine
state: Zhejiang
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: LanZhou University
name: Xiaolong Qi, MD
role: STUDY_CHAIR
affiliation: Huashan Hospital
name: Wenhong Zhang, MD
role: STUDY_CHAIR
References:
citation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
citation: World Health Organization. Coronavirus disease (COVID-2019) situation reports[EB/OL]. https: //www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/.
citation: 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.
citation: Iavarone M, D'Ambrosio R, Soria A, Triolo M, Pugliese N, Del Poggio P, Perricone G, Massironi S, Spinetti A, Buscarini E, Vigano M, Carriero C, Fagiuoli S, Aghemo A, Belli LS, Luca M, Pedaci M, Rimondi A, Rumi MG, Invernizzi P, Bonfanti P, Lampertico P. High rates of 30-day mortality in patients with cirrhosis and COVID-19. J Hepatol. 2020 Nov;73(5):1063-1071. doi: 10.1016/j.jhep.2020.06.001. Epub 2020 Jun 9.
citation: Qi X, Wang J, Li X, Wang Z, Liu Y, Yang H, Li X, Shi J, Xiang H, Liu T, Kawada N, Maruyama H, Jiang Z, Wang F, Takehara T, Rockey DC, Sarin SK; COVID-Cirrhosis-CHESS Group. Clinical course of COVID-19 in patients with pre-existing decompensated cirrhosis: initial report from China. Hepatol Int. 2020 Jul;14(4):478-482. doi: 10.1007/s12072-020-10051-z. Epub 2020 May 22.
citation: Moon AM, Webb GJ, Aloman C, Armstrong MJ, Cargill T, Dhanasekaran R, Genesca J, Gill US, James TW, Jones PD, Marshall A, Mells G, Perumalswami PV, Qi X, Su F, Ufere NN, Barnes E, Barritt AS, Marjot T. High mortality rates for SARS-CoV-2 infection in patients with pre-existing chronic liver disease and cirrhosis: Preliminary results from an international registry. J Hepatol. 2020 Sep;73(3):705-708. doi: 10.1016/j.jhep.2020.05.013. Epub 2020 May 21. No abstract available.
citation: Qi X, Liu Y, Wang J, Fallowfield JA, Wang J, Li X, Shi J, Pan H, Zou S, Zhang H, Chen Z, Li F, Luo Y, Mei M, Liu H, Wang Z, Li J, Yang H, Xiang H, Li X, Liu T, Zheng MH, Liu C, Huang Y, Xu D, Li X, Kang N, He Q, Gu Y, Zhang G, Shao C, Liu D, Zhang L, Li X, Kawada N, Jiang Z, Wang F, Xiong B, Takehara T, Rockey DC; COVID-Cirrhosis-CHESS Group. Clinical course and risk factors for mortality of COVID-19 patients with pre-existing cirrhosis: a multicentre cohort study. Gut. 2021 Feb;70(2):433-436. doi: 10.1136/gutjnl-2020-321666. Epub 2020 May 20. No abstract available.
citation: He Q, Zhang G, Gu Y, Wang J, Tang Q, Jiang Z, Shao C, Zhang H, Chen Z, Ma B, Liu D, Xie G, Xu D, Huang Y, Zhang H, Liang M, Huang H, Wang Y, Liu H, Yang J, Pan H, Zou S, Li F, Wang F, Liu C, Wang W, Xiong B, Li X, Liu L, Yang J, Qi X. Clinical Characteristics of COVID-19 Patients With Pre-existing Hepatitis B Virus Infection: A Multicenter Report. Am J Gastroenterol. 2021 Feb 1;116(2):420-421. doi: 10.14309/ajg.0000000000000924. No abstract available.
citation: Cornberg M, Buti M, Eberhardt CS, Grossi PA, Shouval D. EASL position paper on the use of COVID-19 vaccines in patients with chronic liver diseases, hepatobiliary cancer and liver transplant recipients. J Hepatol. 2021 Apr;74(4):944-951. doi: 10.1016/j.jhep.2021.01.032. Epub 2021 Feb 6.
citation: Xia S, Duan K, Zhang Y, Zhao D, Zhang H, Xie Z, Li X, Peng C, Zhang Y, Zhang W, Yang Y, Chen W, Gao X, You W, Wang X, Wang Z, Shi Z, Wang Y, Yang X, Zhang L, Huang L, Wang Q, Lu J, Yang Y, Guo J, Zhou W, Wan X, Wu C, Wang W, Huang S, Du J, Meng Z, Pan A, Yuan Z, Shen S, Guo W, Yang X. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials. JAMA. 2020 Sep 8;324(10):951-960. doi: 10.1001/jama.2020.15543.
citation: Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.
citation: Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. doi: 10.1016/S1473-3099(20)30843-4. Epub 2020 Nov 17.