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NCT04422379 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04422379
Other study ID # COVID 19/LI/2020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 7, 2020
Est. completion date August 30, 2020

Study information
Verified date June 2020
Source Max Healthcare Insititute Limited
Contact Kaushal Madan, DM
Phone 9958787720
Email K_madan_2000@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 314
Est. completion date August 30, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
India Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation) New Delhi Dlelhi

Sponsors (1)
Lead Sponsor Collaborator
Max Healthcare Insititute Limited

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID-19 Positive Case To study the prevalence of liver live injury & factors associated with among patients in-fected with SARS-CoV-2. 4-8 weeks
Primary COVID-19 Positive Case 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 COVID-19 Positive Case To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients. 4-8 weeks
Secondary COVID-19 Positive Case To define the incidence of development of acute liver failure among these patients 4-8 weeks
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