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Clinical Trials/NCT04422379
NCT04422379
Unknown
Not Applicable

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

Max Healthcare Insititute Limited1 site in 1 country314 target enrollmentJune 7, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Max Healthcare Insititute Limited
Enrollment
314
Locations
1
Primary Endpoint
COVID-19 Positive Case
Last Updated
5 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
June 7, 2020
End Date
August 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Max Healthcare Insititute Limited
Responsible Party
Sponsor

Eligibility Criteria

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

  • Patients less that 18 years old with COVID-19
  • Pregnant ladies with COVD-19
  • Unwilling to give consent for inclusion

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • COVID-19 Positive Case(4-8 weeks)

Study Sites (1)

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