The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT05167305
• Collaborator: (none)
• Enrollment: 1,316
• Location: 1
• Actual Duration (Days): 9
• Patients Per Site Per Month: 4450.6

Study Details

Study Description

Brief Summary

Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate.

Monitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases	Other: This is an observational study

Study Design

• Study Type: Observational
• Actual Enrollment: 1316 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease-A Record Based Cross-Sectional Study.
• Actual Study Start Date: Dec 22, 2021
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
liver disease without COVID-19 infection-April-May 2019	Other: This is an observational study; This is an observational study
liver disease without COVID-19 infection -April- May 2021	Other: This is an observational study; This is an observational study

Outcome Measures

Primary Outcome Measures

1. Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019. [Until discharge or death]

Secondary Outcome Measures

1. Comparison of 30 days readmission rate of patients of liver disease. [Day 30]

2. Comparison of 31 to 90 days readmission rate of patients of liver disease. [Day 31-90]

3. Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients of liver disease requiring hospital admission

Exclusion Criteria:

1. Active COVID-19 infection at time of admission or acquiring during hospital stay.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver & Biliary Sciences	New Delhi	Delhi	India	110070

Sponsors and Collaborators

• Institute of Liver and Biliary Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Liver and Biliary Sciences, India
• ClinicalTrials.gov Identifier: NCT05167305
• Other Study ID Numbers: ILBS-COVID-07
• First Posted: Dec 22, 2021
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases

Study Results

No Results Posted as of Jan 4, 2022