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COVID-19NCT04883177

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

An observational study of COVID-19 and Liver Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 37 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Liver Disease, Vaccine Reaction
How many people
1,000 participants
Where
37 sitesChina
Study dates
11 May 2021to 1 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Baoding People's Hospital

    Baoding, Heibei

  • Beijing You'an Hospital

    Beijing, Beijing Municipality

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

    Chengdu, Sichuan

  • Chongqing Fuling Central Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Jinchang Central Hospital

    Jinchang, Gansu

  • Jincheng People's Hospital

    Jincheng, Shanxi

  • Jinzhou Central Hospital

    Jinzhou, Liaoning

  • Affiliated Hospital of Yunnan University

    Kunming, Yunnan

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The Third People's Hospital of Tibet Autonomous Region

    Lhasa, Tibet

  • The Third People's Hospital of Linfen City

    Linfen, Shanxi

  • The Central Hospital of Lishui City

    Lishui, Zhejiang

  • Beilun Hospital of Traditional Chinese Medicine

    Ningbo, Zhejiang

  • Qingdao Sixth People's Hospital

    Qingdao, Shandong

  • Qingyang People's Hospital

    Qingyang, Gansu

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

  • Sixth People's Hospital of Shenyang

    Shenyang, Liaoning

  • The First People's Hospital of Taicang

    Taicang, Jiangsu

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

  • Taiyuan Third People's Hospital

    Taiyuan, Shanxi

  • Tianjin Second People's Hospital

    Tianjin, Tianjin Municipality

  • Tianjin Third Central Hospital

    Tianjin, Tianjin Municipality

  • Wuhan Jinyintan Hospital

    Wuhan, Hubei

  • Wuxi Fifth People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Xingtai People's Hospital

    Xingtai, Hebei

  • Qishan Hospital of Yantai City

    Yantai, Shandong

  • Yibin First People's Hospital

    Yibin, Sichuan

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia

  • The Fourth Affiliated Hospital of Zhejiang University

    Yiwu, Zhejiang

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The Affiliated Third Hospital of Jiangsu University

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: Effectiveness and Safety of the COVID-19 Vaccination for Patients With Liver Disease (CHESS2101): a Multicenter Cohort Study

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.

Read the 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.

Medical subject headings
COVID-19, Liver Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 7 days after each injection

Secondary outcomes (5)

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

    Measured: up to 28 days after each injection

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2021
  2. Study start11 May 2021
  3. Primary completion1 Jan 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883177
Sponsor's protocol ID
CHESS2101
Status last verified
Apr 2023
First submitted
29 Apr 2021
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32109013

  • 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.

    PubMed 32623632

  • 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.

    PubMed 32526252

  • 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.

    PubMed 32440857

  • 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.

    PubMed 32446714

  • 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.

    PubMed 32434831

  • 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.

    PubMed 32925195

  • 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.

    PubMed 33563499

  • 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.

    PubMed 32789505

  • 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.

    PubMed 33378609

  • 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.

    PubMed 33217362

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Liver Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 37 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events within 7 days after each injection (time frame: up to 7 days after each injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04883177, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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