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

NCT ID: NCT04422379

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-07

Study Completion Date

2020-08-30

Brief Summary

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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

Detailed Description

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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

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

\-

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Max Healthcare Insititute Limited

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaushal Madan, DM

Role: PRINCIPAL_INVESTIGATOR

Max healthcare

Locations

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Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation)

New Delhi, Dlelhi, India

Site Status

Countries

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India

Central Contacts

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Kaushal Madan, DM

Role: CONTACT

9958787720

Vivek Raj, DM

Role: CONTACT

9818921051

Facility Contacts

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Rajesh Saxena

Role: primary

9818474003

Other Identifiers

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COVID 19/LI/2020

Identifier Type: -

Identifier Source: org_study_id

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