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Status unknownNCT04345640Updated Sep 3, 2020

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

An observational study in Liver Cirrhoses, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Institute of Liver and Biliary Sciences, India · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 70 Years
Sex
All
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Study 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

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Conditions studied

  • Liver Cirrhoses

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03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All Covid-19 patients with or without liver disease

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. No Valid consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Covid-19 with liver disease

    Covid-19 with liver disease

    Other: no intervention

  • Covid-19 without liver disease

    Covid-19 without liver disease

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

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What researchers measure

Primary outcomes

  1. Spontaneous recovery or death in both groups

    Time frame: 90 days

Secondary outcomes

  1. Severity of prior as well as present decompensation in both groups

    Time frame: 90 days

  2. Duration of prior as well as present decompensation in both groups

    Time frame: 90 days

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

    Time frame: 90 days

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

    Time frame: 90 days

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

    Time frame: 90 days

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

    Time frame: 90 days

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

    Time frame: 90 days

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Study locations

1 of 1 sites recruiting
  • Institute of Liver and Biliary Sciences
    New Delhi, Delhi 110070, India
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04345640
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Apr 14, 2020
Start date
Apr 10, 2020
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Sep 3, 2020

Study contacts

Dr Ashok Choudhary, DM
Contact
akchoudhury@ilbs.in
01146300000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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