COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study

June 7, 2020 updated by: Max Healthcare Insititute Limited

COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.

All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 & prospective data from approval till 30/6/2020), will be included

Study Overview

Status

Unknown

Conditions

Detailed Description

COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.

All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 & prospective data from approval till 30/6/2020), will be included Primary objectives

  1. To study the prevalence of liver live injury & factors associated with among patients in-fected with SARS-CoV-2.
  2. To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVD-19.

Secondary objectives

  1. To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
  2. To define the incidence of development of acute liver failure among these patients

Study Type

Observational

Enrollment (Anticipated)

314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Dlelhi
      • New Delhi, Dlelhi, India, 110017
        • Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will include all the COVID 19 patients (male & female) with minimum age 18 years old. And take 60% patient in Retrospective arm and 40% patient in prospective arm.

Description

Inclusion Criteria:All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 & prospective data from approval till 30/6/2020), will be included.

-

Exclusion Criteria:

  1. Patients less that 18 years old with COVID-19
  2. Pregnant ladies with COVD-19
  3. Unwilling to give consent for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Positive Case
Time Frame: 4-8 weeks
To study the prevalence of liver live injury & factors associated with among patients in-fected with SARS-CoV-2.
4-8 weeks
COVID-19 Positive Case
Time Frame: 4-8 weeks
To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVID-19.
4-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 Positive Case
Time Frame: 4-8 weeks
To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
4-8 weeks
COVID-19 Positive Case
Time Frame: 4-8 weeks
To define the incidence of development of acute liver failure among these patients
4-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max Healthcare Insititute Limited

Investigators

  • Principal Investigator: Kaushal Madan, DM, max healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 7, 2020

Primary Completion (Anticipated)

July 30, 2020

Study Completion (Anticipated)

August 30, 2020

Study Registration Dates

First Submitted

June 7, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID 19/LI/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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