Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-28 @ 5:42 PM
Study NCT ID:
NCT04329559
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2020-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2020-03-29', 'studyFirstSubmitQcDate': '2020-03-29', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality of COVID-19 patients with liver cirrhosis', 'timeFrame': 'From illness onset of COVID-19 to death from any cause, up to 365 days', 'description': '7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis'}], 'secondaryOutcomes': [{'measure': 'Liver-related mortality of COVID-19 patients with liver cirrhosis', 'timeFrame': 'From illness onset of COVID-19 to death from liver-related cause, up to 365 days', 'description': '7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis'}, {'measure': 'Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis', 'timeFrame': 'From hospital admission to death, up to 365 days', 'description': 'Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis'}, {'measure': 'Baseline characteristics of COVID-19 patients with liver cirrhosis', 'timeFrame': '1 Day', 'description': 'Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Liver cirrhosis', 'Clinical outcome'], 'conditions': ['COVID-19', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '32091533', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32109013', 'type': 'BACKGROUND', '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.'}, {'pmid': '32145190', 'type': 'BACKGROUND', 'citation': 'Zhang 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.'}, {'pmid': '32203680', 'type': 'BACKGROUND', 'citation': 'Bangash 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.'}, {'pmid': '32170806', 'type': 'BACKGROUND', 'citation': 'Xu 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COVID-19 infection with pre-existing liver cirrhosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Aged 18 or above;\n* 2\\) Laboratory-confirmed COVID-19 infection;\n* 3\\) Pre-existing liver cirrhosis based on liver biopsy or clinical findings.\n\nExclusion Criteria:\n\n* 1\\) Pregnancy or unknown pregnancy status.'}, 'identificationModule': {'nctId': 'NCT04329559', 'briefTitle': 'COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study', 'orgStudyIdInfo': {'id': 'CHESS2002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dalian', 'country': 'China', 'facility': "Dalian Sixth People's Hospital", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Enshi', 'country': 'China', 'facility': 'Minda Hospital Affiliated to Hubei University for Nationalities', 'geoPoint': {'lat': 30.3, 'lon': 109.48333}}, {'city': 'Enshi', 'country': 'China', 'facility': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture', 'geoPoint': {'lat': 30.3, 'lon': 109.48333}}, {'city': 'Lanzhou', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Lishui', 'country': 'China', 'facility': 'The Central Hospital of Lishui City', 'geoPoint': {'lat': 28.46042, 'lon': 119.91029}}, {'city': 'Nanning', 'country': 'China', 'facility': 'Guangxi Zhuang Autonomous Region', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'The Sixth Peoples Hospital of Shenyang', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenzhen', 'country': 'China', 'facility': "Shenzhen Third People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Suizhou', 'country': 'China', 'facility': 'Suizhou Hospital, Hubei University of Medicine', 'geoPoint': {'lat': 31.71111, 'lon': 113.36306}}, {'city': 'Tianjin', 'country': 'China', 'facility': "Tianjin Second People's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Ankang Central Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xingtai', 'country': 'China', 'facility': "Xingtai People's Hospital", 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'city': 'Zhenjiang', 'country': 'China', 'facility': 'The Affiliated Third Hospital of Jiangsu University', 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}], 'overallOfficials': [{'name': 'Mingkai Chen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Renmin Hospital of Wuhan University'}, {'name': 'Xiaolong Qi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'LanZhou University'}, {'name': 'Fengmei Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Tianjin Second People's Hospital"}, {'name': 'Ye Gu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Sixth People's Hospital of Shenyang"}, {'name': 'Zicheng Jiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankang Central Hospital'}, {'name': 'Guo Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangxi Zhuang Autonomous Region'}, {'name': 'Yong Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dalian Sixth People's Hospital"}, {'name': 'Dengxiang Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Xingtai People's Hospital"}, {'name': 'Qing He, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shenzhen Third People's Hospital"}, {'name': 'Hua Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minda Hospital Affiliated to Hubei University for Nationalities'}, {'name': 'Zhengyan Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suizhou Hospital, Hubei University of Medicine'}, {'name': 'Bin Xiong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, {'name': 'Xiaodan Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture'}, {'name': 'Hongguang Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Third Hospital of Jiangsu University'}, {'name': 'Chuxiao Shao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Central Hospital of Lishui City'}, {'name': 'Hongmei Yue, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LanZhou University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'collaborators': [{'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'Minda Hospital Affiliated to Hubei University for Nationalities', 'class': 'UNKNOWN'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture', 'class': 'OTHER'}, {'name': "Tianjin Second People's Hospital", 'class': 'OTHER'}, {'name': "The Sixth People's Hospital of Shenyang", 'class': 'OTHER'}, {'name': 'Guangxi Zhuang Autonomous Region', 'class': 'UNKNOWN'}, {'name': "Shenzhen Third People's Hospital", 'class': 'OTHER'}, {'name': 'Ankang Central Hospital', 'class': 'OTHER'}, {'name': "Xingtai People's Hospital", 'class': 'OTHER'}, {'name': "Dalian Sixth People's Hospital", 'class': 'UNKNOWN'}, {'name': 'The Central Hospital of Lishui City', 'class': 'OTHER'}, {'name': 'The Affiliated Third Hospital of Jiangsu University', 'class': 'UNKNOWN'}, {'name': 'Suizhou Hospital, Hubei University of Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Institute of Portal Hypertension', 'investigatorFullName': 'Xiaolong Qi', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}