The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver.
1 other identifier
observational
1,000
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2020
CompletedStudy Start
First participant enrolled
April 10, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedSeptember 3, 2020
April 1, 2020
9 months
April 10, 2020
September 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Spontaneous recovery or death in both groups
90 days
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Covid-19 with liver disease
Covid-19 with liver disease
Covid-19 without liver disease
Covid-19 without liver disease
Interventions
Eligibility Criteria
All Covid-19 patients with or without liver disease
You may qualify if:
- All patients of COVID-19 positive
- Age 18-70 years
You may not qualify if:
- No Valid consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2020
First Posted
April 14, 2020
Study Start
April 10, 2020
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
September 3, 2020
Record last verified: 2020-04