| CTRI Number |
CTRI/2020/06/025858 [Registered on: 13/06/2020] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Observational study on suspected COVID 19 patients admitted to ICU |
|
Scientific Title of Study
|
Epidemiological study of patients admitted in intensive care unit with severe acute respiratory illness with possible diagnosis of COVID19 (EPIC19) |
| Trial Acronym |
EPIC 19 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amarja Ashok Havaldar |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical college |
| Address |
Department of Critical Care medicine St Johns Hospital Bangalore
KARNATAKA Department of Critical Care medicine St Johns
Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India
Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarja Ashok Havaldar |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical college |
| Address |
Department of Critical Care medicine St Johns Hospital Bangalore
KARNATAKA Department of Critical Care medicine St Johns
Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India
Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarja Ashok Havaldar |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical college |
| Address |
Department of Critical Care medicine St Johns Hospital Bangalore
KARNATAKA Department of Critical Care medicine St Johns
Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India
Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9036082112 |
| Fax |
|
| Email |
amarjahavaldar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Amarja Ashok Havaldar |
| Address |
Department of Critical Care medicine, St Johns Hospital Bangalore
KARNATAKA Bangalore KARNATAKA |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Sangle |
Apollo Hospital Nashik |
Department of Critical care
Nashik
MAHARASHTRA |
8975580465
dras9111984@gmail.com |
| Dr Jayprakash |
RIMS |
Department of Critical care medicine
Ranchi
JHARKHAND |
8084715507
dr.jay_prakash@rediffmail.com |
| Dr Amarja Ashok Havaldar |
St Johns Medical college |
Department of Critical
Care medicine, St
Johns Hospital
Bangalore
KARNATAKA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9036082112
amarjahavaldar@rediffmail.com |
| Dr Munta Kartik |
Yashoda Hospital |
Department of Critical care
Hyderabad
TELANGANA |
9885263990
dr.kartikmunta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Apollo Hospital Nashik |
Approved |
| RIMS Ranchi |
Approved |
| St Johns Medical college |
Approved |
| Yashoda Hospital |
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, (2) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with severe acute respiratory illness and with possible diagnosis of COVID, requiring intensive care will be included |
|
| ExclusionCriteria |
| Details |
Patients with respiratory failure or pneumonia not explained by COVID will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the epidemiology and clinical characteristics of patients admitted with SARI possibly due to COVID19 and their outcome
|
ICU mortality
at 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of ventilator free days
ICU length of stay
ICU mortality
Study correlation between steroid and mortality
Correlation between different biomarkers and mortality
|
Hospital mortality at 90 days |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
22/06/2020 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is the study on epidemiology and clinical profile of the COVID suspected patients admitted in ICU Planeed for publication at the end of the study. Planned for collaboration with other centres from INDIA For multicentric project |