| CTRI Number |
CTRI/2020/06/025802 [Registered on: 10/06/2020] Trial Registered Prospectively |
| Last Modified On: |
08/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study |
|
Scientific Title of Study
|
COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaushal Madan |
| Designation |
Director of Gastroenterology and Hepatology |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017
Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017
South
DELHI
110017
India |
| Phone |
9958787720 |
| Fax |
|
| Email |
K_madan_2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saroj Kumar Sbath |
| Designation |
GM |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017
Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017
South
DELHI
110017
India |
| Phone |
9999325464 |
| Fax |
|
| Email |
Saroj.kumar@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Saxena |
| Designation |
DGM |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017
Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017
South
DELHI
110017
India |
| Phone |
9818474003 |
| Fax |
|
| Email |
Rajesh.Saxena@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital Mandir Marg Press Enclave Road Saket New Delhi-110017 |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital |
| Address |
Mandir Marg, Press Enclave Road, Saket, new Dlehi-110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Raj |
Max Smart super Speciality Hospital, Press Enclave Road, Mandir Marg, Saket, New Delhi-110017 |
1st Floor, Clinical Research Department
South
DELHI |
9818921051
Vivek.Raj@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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- 30/4/2020 & prospective data from approval till 30/6/2020), will be included. |
|
| ExclusionCriteria |
| Details |
1. Patients less that 18 years old with COVID-19
2. Pregnant ladies with COVD-19
3. Unwilling to give consent for inclusion
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
• Prevalence of liver injury in patients infected with SARS-CoV-2 virus.
• Prevalence of new liver injury in patients having COVD-19 infection over underlying liver dis-eases.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Incidence of Acute liver failure
• Incidence of ACLF
• Mortality
|
4-8 weeks |
|
|
Target Sample Size
|
Total Sample Size="314"
Sample Size from India="314"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 and measure outcomes Prevalence of liver injury in patients
infected with SARS-CoV-2 virus and Prevalence of new liver injury in patients having
COVD-19 infection over underlying liver diseases as a primary outcomes and Incidence of Acute liver failure, Incidence of ACLF and Mortality as secondary outcome |