COVID-19 and Liver Injury in Patients With or Without Und... | NCT04422379

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

NCT04422379

Sponsor

Max Healthcare Insititute Limited

Status

Unknown status

Last Update Posted

Jun 9, 2020Actual

Enrollment

314Estimated

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2020Estimated

Primary Completion Date

Jul 30, 2020Estimated

Completion Date

Aug 30, 2020Estimated

First Submitted Date

Jun 7, 2020

First Submission Date that Met QC Criteria

Jun 7, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2020

Last Update Posted Date

Jun 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

To study the prevalence of liver live injury & factors associated with among patients in-fected with SARS-CoV-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

To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
To define the incidence of development of acute liver failure among these patients

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

314Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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 Outcomes

Measure	Description	Time Frame
COVID-19 Positive Case	To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.	4-8 weeks
COVID-19 Positive Case	To define the incidence of development of acute liver failure among these patients

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kaushal Madan, DM	Contact	9958787720		K_madan_2000@yahoo.com
Vivek Raj, DM	Contact	9818921051		Vivek.Raj@maxhealthcare.com

Overall Officials

Name	Affiliation	Role
Kaushal Madan, DM	Max healthcare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation)		New Delhi	Dlelhi	110017	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided