The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver.

• Conditions: Liver Cirrhoses
• Interventions: Other: no intervention

• Registration Number: NCT04345640
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

To address the existing deficiencies in the knowledge regarding liver involvement and spectrum of clinical presentation and the impact of COVID-19 infection in patients of liver disease was planned. The present study will be a hospital based and the cases of confirmed COVID-19 infection will be evaluated in relation to liver involvement irrespective of pre-existing liver disease. The primary objective was to address the clinical presentation, biochemical alteration and outcomes of COVID-19 infection in subjects with chronic hepatitis, cirrhosis in comparison to those having infection in the absence of pre-existing liver disease

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-10
• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-14
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-03
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. All patients of COVID-19 positive
2. Age 18-70 years

Exclusion Criteria

1. No Valid consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Covid-19 with liver disease	no intervention	Covid-19 with liver disease
Covid-19 without liver disease	no intervention	Covid-19 without liver disease

Primary Outcome Measures

Name	Time	Method
Spontaneous recovery or death in both groups	90 days

Secondary Outcome Measures

Name	Time	Method
Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II in both groups	90 days
Duration of prior as well as present decompensation in both groups	90 days
Severity of prior as well as present decompensation in both groups	90 days
Improvement in severity assessment Indices Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF SOFA) scores in both groups.	90 days
Improvement in severity assessment Indices Model for End Stage Liver Disease (MELD) scores in both groups	90 days
Improvement in severity assessment Indices Child-Turcotte-Pugh (CTP) scores in both groups	90 days
Improvement in severity assessment Indices Sequential Organ Failure Assessment (SOFA) scores in both groups	90 days

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India