| CTRI Number |
CTRI/2020/11/029067 [Registered on: 12/11/2020] Trial Registered Prospectively |
| Last Modified On: |
11/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
A study to look out outcomes of treated COVID-19 patients admitted to a private hospital in Bangalore |
|
Scientific Title of Study
|
A retrospective study of presentation, treatment and outcome of COVID-19 patients admitted to a private hospital in Bangalore |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Girish Namagondlu |
| Designation |
Consultant Nephrologist |
| Affiliation |
ColumbiaAsia Hospital, Hebbal |
| Address |
Room No.12
Department of Nephrology
Kirloskar Business Park
Bellary Road, Hebbal
Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9880825431 |
| Fax |
|
| Email |
girishnamagondlu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Girish Namagondlu |
| Designation |
Consultant Nephrologist |
| Affiliation |
ColumbiaAsia Hospital, Hebbal |
| Address |
Room No.12
Department of Nephrology
Kirloskar Business Park
Bellary Road, Hebbal
Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9880825431 |
| Fax |
|
| Email |
girishnamagondlu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Girish Namagondlu |
| Designation |
Consultant Nephrologist |
| Affiliation |
ColumbiaAsia Hospital, Hebbal |
| Address |
Room No.12
Department of Nephrology
Kirloskar Business Park
Bellary Road, Hebbal
Bangalore
Bangalore
KARNATAKA
560024
India |
| Phone |
9880825431 |
| Fax |
|
| Email |
girishnamagondlu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ColumbiaAsia Hospital |
| Address |
Kirloskar Business park
Bellary road
Hebbal
Bangalore |
| 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 |
| Girish Namagondlu |
ColumbiaASia Hospital Hebbal |
Department of Nephrology
Room 12
Kirloskar business park
Bellary road
Hebbal, Bangalore 560024
Bangalore
KARNATAKA |
9880825431
girishnamagondlu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ColumbiaAsiaHospitals |
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: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
COVID positive patients admitted from June 2020 to sep2020 |
|
| ExclusionCriteria |
| Details |
age <18yrs
covid positive outpatiens |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Recovery and fatality rates of treated COVID admissions at our centre
|
Baseline and at 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| readmissions |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/11/2020 |
| 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="0"
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
|
Background First case of COVID in India was reported in January 2020. COVID pandemic in India peaked around September 2020. Case fatality rates in India seems lower than rest of the world. Over 5000 articles of COVID-19 have been published in peer reviewed journals from various countries. Despite high case load and commendable treatment in India, very few publications have featured in peer reviewed journals. Indian data would be very useful for us to understand the impact of various regimens recommended by ICMR . Its been proven that SARS COV-2 affects kidneys and results in acute kidney injury. Incidence of acute kidney injury in COVID patients varies for 5% to 40% according to various studies in the literature. Our study also aims to know the renal outcomes in COVID positive patients in our subset of population.
Primary Objective To find out presentations, manifestations, treatment, case fatality rates and outcomes of COVID positive patients admitted to a private hospital in Bangalore
Secondary Objective To know the Incidence of Acute kidney injury and kidney outcomes related to COVID positive patients |