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

• Sponsor: Institute of Liver and Biliary Sciences, India (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04345640
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 114.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhoses	Other: no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Apr 10, 2020
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Spontaneous recovery or death in both groups [90 days]

Secondary Outcome Measures

1. Severity of prior as well as present decompensation in both groups [90 days]

2. Duration of prior as well as present decompensation in both groups [90 days]

3. Improvement in severity assessment Indices Model for End Stage Liver Disease (MELD) scores in both groups [90 days]

4. Improvement in severity assessment Indices Child-Turcotte-Pugh (CTP) scores in both groups [90 days]

5. Improvement in severity assessment Indices Sequential Organ Failure Assessment (SOFA) scores in both groups [90 days]

6. Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II in both groups [90 days]

7. Improvement in severity assessment Indices Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF SOFA) scores in both groups. [90 days]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. All patients of COVID-19 positive

2. Age 18-70 years

Exclusion Criteria:

1. No Valid consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Liver and 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: NCT04345640
• Other Study ID Numbers: ILBS-COVID-01
• First Posted: Apr 14, 2020
• Last Update Posted: Sep 3, 2020
• Last Verified: Apr 1, 2020

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

Study Results

No Results Posted as of Sep 3, 2020