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

Liver Cirrhoses Clinical Trial

Official title:

The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver - The Pan Asia-Pacific Prospective Multi-centre Observational Study (APCOLIS STUDY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04345640
• Other study ID #: ILBS-COVID-01
• Status: Recruiting
• Start date: April 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Ashok Choudhary, DM
• Phone: 01146300000
• Email: akchoudhury[@]ilbs.in
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. All patients of COVID-19 positive

2. Age 18-70 years

Exclusion Criteria:

1. No Valid consent

Related Conditions & MeSH terms

• Liver Cirrhoses
• Liver Cirrhosis

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous recovery or death in both groups		90 days
Secondary	Severity of prior as well as present decompensation in both groups		90 days
Secondary	Duration of prior as well as present decompensation in both groups		90 days
Secondary	Improvement in severity assessment Indices Model for End Stage Liver Disease (MELD) scores in both groups		90 days
Secondary	Improvement in severity assessment Indices Child-Turcotte-Pugh (CTP) scores in both groups		90 days
Secondary	Improvement in severity assessment Indices Sequential Organ Failure Assessment (SOFA) scores in both groups		90 days
Secondary	Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II in both groups		90 days
Secondary	Improvement in severity assessment Indices Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF SOFA) scores in both groups.		90 days