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

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

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

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Dr Ashok Choudhary, DM; Phone Number: 01146300000; Email: akchoudhury@ilbs.in

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of liver and Biliary Sciences
      • Contact: Dr Ashok Choudhary, DM; Phone Number: 01146300000; Email: akchoudhury@ilbs.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All Covid-19 patients with or without liver disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. No Valid consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covid-19 with liver disease	Other: no intervention; no intervention
Covid-19 without liver disease	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Spontaneous recovery or death in both groups	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Severity of prior as well as present decompensation in both groups	90 days
Duration of prior as well as present decompensation 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
Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II 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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-COVID-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No