| CTRI Number |
CTRI/2022/03/040908 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
COVID-19 pneumonia in patients with underlying fatty liver |
|
Scientific Title of Study
|
A Retrospective, Observational, Multicentre study on Outcomes of COVID-19 pneumonia in patients with underlying fatty liver |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaushal Madan |
| Designation |
Director Gastroenterology and Hepatology |
| Affiliation |
Max Smart Super Specialty Hospital |
| Address |
Department of Gastroenterology & Hepatology, Ground Floor
Max Smart Super Speciality Hospital, Saket
South
DELHI
110017
India |
| Phone |
09958787720 |
| Fax |
|
| Email |
k_madan_2000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaushal Madan |
| Designation |
Director Gastroenterology and Hepatology |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Department of Gastroenterology & Hepatology, Ground Floor
Max Smart Super Speciality Hospital, Saket
South
DELHI
110017
India |
| Phone |
09958787720 |
| Fax |
|
| Email |
k_madan_2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Saxena |
| Designation |
GM Clinical Research |
| Affiliation |
Max Super Speciality Hospital |
| Address |
7th Floor, Office of Research, West Block, Max Super Speciality Hospital, Saket, (A unit of Max Healthcare Institute Limited) 1, Press Enclave Road, Saket, New Delhi-110017, India
South
DELHI
110017
India |
| Phone |
9818474003 |
| Fax |
|
| Email |
rajesh.saxena@maxhealthcare.com |
|
|
Source of Monetary or Material Support
|
| Max Smart Super Speciality Hospital A unit of Gujarmal Modi Hospital and Research Centre for Medical Sciences |
|
|
Primary Sponsor
|
| Name |
MAX Smart Super specialty Hospital A unit of Gujarmal Modi Hospital |
| Address |
Mandir Marg Press Enclave Road Saket New Delhi |
| 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 Kaushal Madan |
Max Smart Super Speciality Hospital A unit of Gujarmal Modi Hospital |
Department of Gastroenterology & Hepatology, Ground Floor Max Smart Super Speciality Hospital, Saket
South
DELHI |
9968407407
k_madan_2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee (MHEC) |
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 |
1. Patients who are positive for SARS CoV-2 nasopharyngeal swab RT-PCR
2. Patients with no history of underlying liver cirrhosis, fatty liver
3. Patients with no history of underlying liver cancer
4. Patients with no cardiac ailment
5. Patients with a CT severity score of > 1
6. Availability of upper abdominal cuts on the HRCT chest |
|
| ExclusionCriteria |
| Details |
1. Patients how are negative for SARS CoV-2 nasopharyngeal swab RT-PCR
2. Patients with known history of underlying cirrhosis.
3. Patients with known history of underlying liver cancer
4. Patients with CHF
5. Patients with a CT severity score of < 1
6. Non-availability of upper abdominal cuts on the HRCT chest
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality rates of patients with COVID-19 pneumonia with underlying fatty liver |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Morbidity rates of patients with COVID-19 pneumonia with underlying fatty liver.
The morbidity parameters to be studied are:
1. Need for ICU admission
2. Need for Ventilatory support
3. Length of ICU stay
4. Length of hospital stay
|
30 Days |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
15/03/2022 |
| 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="5"
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)?
Response - NO
|
|
Brief Summary
|
The Pandemic of COVID-19 has led to significant morbidity and mortality across the world since the early part of 2020. The Severe acute respiratory syndrome SARS CoV-2 primary affects the respiratory system and most deaths are related to the severe viral pneumonia and respiratory failure. However, other organ systems also seem to get affected to a variable degree. Patients who have underling co-morbidity seem to be more predisposed to worst outcomes. Almost 1/3rd to 3/4th of patients with COVID-19 have been reported to have some degree of liver injury at the time of presentation. Due to this patients with preexisting liver disease, especially those with cirrhosis have been reported to develop decompensation when they acquire infection with SARS-CoV-2. The data on the outcomes , especially mortality of COVID-19 among patient who have underlying fatty liver is limited and is fraught with ascertainment bias.
|