COVID-19NCT04329559
COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
An observational study of COVID-19 and Liver Cirrhosis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 15 sites in China.
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 cirrhosis 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 Cirrhosis
- How many people
- 21 participants
- Where
- 15 sitesChina
- Study dates
- 30 Mar 2020to 10 Feb 2021
- How long will I take part?
- 1 Year
- 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: Patients with COVID-19 infection with pre-existing liver cirrhosis
Who may be able to join
- 1) Aged 18 or above;
- 2) Laboratory-confirmed COVID-19 infection;
- 3) Pre-existing liver cirrhosis based on liver biopsy or clinical findings.
Who cannot join
- 1) Pregnancy or unknown pregnancy status.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Dalian Sixth People's Hospital
Dalian
Minda Hospital Affiliated to Hubei University for Nationalities
Enshi
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Enshi
The First Hospital of Lanzhou University
Lanzhou
The Central Hospital of Lishui City
Lishui
Guangxi Zhuang Autonomous Region
Nanning
The Sixth Peoples Hospital of Shenyang
Shenyang
Shenzhen Third People's Hospital
Shenzhen
Suizhou Hospital, Hubei University of Medicine
Suizhou
Tianjin Second People's Hospital
Tianjin
Ankang Central Hospital
Wuhan
Renmin Hospital of Wuhan University
Wuhan
Wuhan Union Hospital
Wuhan
Xingtai People's Hospital
Xingtai
The Affiliated Third Hospital of Jiangsu University
Zhenjiang
About this study
Official title: Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational 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 cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
Read the detailed description
Coronavirus disease 2019 (COVID-19) pandemic with severe acute respiratory syndrome coronavirus 2 (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 cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
- Conditions
- COVID-19, Liver Cirrhosis
- Keywords
- COVID-19, Liver cirrhosis, Clinical outcome
- Medical subject headings
- COVID-19, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality of COVID-19 patients with liver cirrhosis
7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis
Measured: From illness onset of COVID-19 to death from any cause, up to 365 days
Secondary outcomes (3)
Liver-related mortality of COVID-19 patients with liver cirrhosis
7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis
Measured: From illness onset of COVID-19 to death from liver-related cause, up to 365 days
Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis
Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis
Measured: From hospital admission to death, up to 365 days
Baseline characteristics of COVID-19 patients with liver cirrhosis
Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start30 Mar 2020
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 21 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, LanZhou University, Minda Hospital Affiliated to Hubei University for Nationalities, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Tianjin Second People's Hospital, Shenyang Sixth People's Hospital, Guangxi Zhuang Autonomous Region, Shenzhen Third People's Hospital, Ankang Central Hospital, Xingtai People's Hospital, Dalian Sixth People's Hospital, The Central Hospital of Lishui City, Affiliated Hospital of Jiangsu University, Suizhou Hospital, Hubei University of Medicine
- Responsible party
- Principal investigator, Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Mingkai Chen, MD, Study chair, Renmin Hospital of Wuhan UniversityXiaolong Qi, MD, Study chair, LanZhou UniversityFengmei Wang, MD, Principal investigator, Tianjin Second People's HospitalYe Gu, MD, Principal investigator, Shenyang Sixth People's HospitalZicheng Jiang, MD, Principal investigator, Ankang Central HospitalGuo Zhang, MD, Principal investigator, Guangxi Zhuang Autonomous RegionYong Zhang, MD, Principal investigator, Dalian Sixth People's HospitalDengxiang Liu, MD, Principal investigator, Xingtai People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329559
- Sponsor's protocol ID
- CHESS2002
- Status last verified
- Feb 2021
- First submitted
- 29 Mar 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Guan 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 32109013Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available.
PubMed 32145190Bangash MN, Patel J, Parekh D. COVID-19 and the liver: little cause for concern. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):529-530. doi: 10.1016/S2468-1253(20)30084-4. Epub 2020 Mar 20. No abstract available.
PubMed 32203680Xu L, Liu J, Lu M, Yang D, Zheng X. Liver injury during highly pathogenic human coronavirus infections. Liver Int. 2020 May;40(5):998-1004. doi: 10.1111/liv.14435. Epub 2020 Mar 30.
PubMed 32170806
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT04329559
- Acronym / sponsor ID
- CHESS2002
- Conditions
- COVID-19, Liver Cirrhosis
- Keywords
- COVID-19, Liver cirrhosis, Clinical outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, LanZhou University, Minda Hospital Affiliated to Hubei University for Nationalities, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Tianjin Second People's Hospital, Shenyang Sixth People's Hospital, Guangxi Zhuang Autonomous Region, Shenzhen Third People's Hospital, Ankang Central Hospital, Xingtai People's Hospital, Dalian Sixth People's Hospital, The Central Hospital of Lishui City, Affiliated Hospital of Jiangsu University, Suizhou Hospital, Hubei University of Medicine
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
Detailed description
Coronavirus disease 2019 (COVID-19) pandemic with severe acute respiratory syndrome coronavirus 2 (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 cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COVID-19 infection with pre-existing liver cirrhosis
Key inclusion criteria (3 listed)
- 1) Aged 18 or above;
- 2) Laboratory-confirmed COVID-19 infection;
- 3) Pre-existing liver cirrhosis based on liver biopsy or clinical findings.
Key exclusion criteria (1 listed)
- 1) Pregnancy or unknown pregnancy status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality of COVID-19 patients with liver cirrhosis
Time frame: From illness onset of COVID-19 to death from any cause, up to 365 days
7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis
3 secondary outcomes
Liver-related mortality of COVID-19 patients with liver cirrhosis
Time frame: From illness onset of COVID-19 to death from liver-related cause, up to 365 days
Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis
Time frame: From hospital admission to death, up to 365 days
Baseline characteristics of COVID-19 patients with liver cirrhosis
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Background: PubMed 32109013Guan 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.
- Background: PubMed 32145190Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available.
- Background: PubMed 32203680Bangash MN, Patel J, Parekh D. COVID-19 and the liver: little cause for concern. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):529-530. doi: 10.1016/S2468-1253(20)30084-4. Epub 2020 Mar 20. No abstract available.
- Background: PubMed 32170806Xu L, Liu J, Lu M, Yang D, Zheng X. Liver injury during highly pathogenic human coronavirus infections. Liver Int. 2020 May;40(5):998-1004. doi: 10.1111/liv.14435. Epub 2020 Mar 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingkai Chen, MD study chair
Renmin Hospital of Wuhan University
Xiaolong Qi, MD study chair
LanZhou University
Fengmei Wang, MD principal investigator
Tianjin Second People's Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Liver Cirrhosis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 15 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 1 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
All-cause mortality of COVID-19 patients with liver cirrhosis (time frame: From illness onset of COVID-19 to death from any cause, up to 365 days). 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 NCT04329559, which also lists 5 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 24 Feb 2021.