Clinical trial NCT04422379: COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study
Official title: COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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

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.

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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

Primary outcomes:
measure: COVID-19 Positive Case
timeFrame: 4-8 weeks
measure: COVID-19 Positive Case
timeFrame: 4-8 weeks
Secondary outcomes:
measure: COVID-19 Positive Case
timeFrame: 4-8 weeks
measure: COVID-19 Positive Case
timeFrame: 4-8 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation)
state: Dlelhi
Study officials:
affiliation: Max healthcare
name: Kaushal Madan, DM
role: PRINCIPAL_INVESTIGATOR
References: