| CTRI Number |
CTRI/2020/04/024914 [Registered on: 29/04/2020] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Characteristics of seriously ill COVID-19 patients admitted to a tertiary care centre |
|
Scientific Title of Study
|
Epidemiology and clinical characteristics of COVID- 19 patients requiring critical care in a tertiary care teaching hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sulagna Bhattacharjee |
| Designation |
Assistant Professor, Dept of Anaesthesiology Pain medicine & Critical Care, AIIMS, New Delhi |
| Affiliation |
AIIMS, New Delhi |
| Address |
96, Gautam Nagar, 2nd floor, Shanti Kutir, New Delhi
Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi-110029
South
DELHI
110049
India |
| Phone |
09818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sulagna Bhattacharjee |
| Designation |
Assistant Professor, Dept of Anaesthesiology Pain medicine & Critical Care, AIIMS, New Delhi |
| Affiliation |
AIIMS, New Delhi |
| Address |
96, Gautam Nagar, 2nd floor, Shanti Kutir, New delhi
Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi-110029
South
DELHI
110049
India |
| Phone |
09818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sulagna Bhattacharjee |
| Designation |
Assistant Professor, Dept of Anaesthesiology Pain medicine & Critical Care, AIIMS, New Delhi |
| Affiliation |
AIIMS, New Delhi |
| Address |
96, Gautam Nagar, 2nd floor, Shanti Kutir, New Delhi
Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi-110029
South
DELHI
110049
India |
| Phone |
09818212531 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Sulagna Bhattacharjee |
| Address |
Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Sulagna Bhattacharjee |
AIIMS, New Delhi |
Rooms No 5011, 5th floor, Teaching Block, AIIMS, New Delhi-110029
South
DELHI |
9818212531
bhattacharjee.sulagna85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
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: J128||Other viral pneumonia, (3) ICD-10 Condition: J128||Other viral pneumonia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling WHO case definition of COVID-19 and admitted in an ICU at AIIMS, New Delhi. |
|
| ExclusionCriteria |
| Details |
Patients or relatives who refused to provide consent or have unproven or suspected COVID- 19 infection will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess ICU mortality in COVID-19 patients admitted to the intensive care unit of AIIMS, New Delhi |
Till ICU stay/ or upto 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To know the incidence of ARDS, AKI, cardiac injury/dysfunction in COVID-19 patients
2. Incidence of prolonged ICU stay (more than 2 weeks)
3. Risk factors associated with poor outcome (mortality or prolonged ICU stay)
|
Till ICU stay |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/05/2020 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Novel Corona virus is a RNA virus, causing COVID-19 disease, leads to lower respiratory tract infection, around around 5 to 10% patients may require respiratory support. 60 adult patients with proven COVID-19 disease admitted to COVID ICU in AIIMS, New Delhi, will be recruited in this epidemiological study. Primary outcome of this study is to assess the ICU mortality, secondary outcomes will be to assess incidence of ARDS, AKI, cardiovascular dysfunction, risk factors for prolonged ICU stay and poor outcome. All baseline demographic and clinical factors will be studied. |