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

• Conditions: COVID-19

• Registration Number: NCT04422379
• Lead Sponsor: Max Healthcare Insititute Limited

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

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-07
• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-06-07
• Last Update Submitted: 2020-06-07
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-07-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 314

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 Positive Case	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 Outcome Measures

Name	Time	Method
COVID-19 Positive Case	4-8 weeks	To define the incidence of development of acute liver failure among these patients

Trial Locations

Locations (1)

Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation); 🇮🇳 New Delhi, Dlelhi, India