| CTRI Number |
CTRI/2020/06/025848 [Registered on: 12/06/2020] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Analysis of Patients Hospitalized Due To Covid-19 |
|
Scientific Title of Study
|
Clinical Analysis of Patients Hospitalized Due To SARS-CoV-2 (Covid-19) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Bhadade |
| Designation |
Associate Professor |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Department of Medicine
Nair Hospital
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027122 |
| Fax |
|
| Email |
rakeshbhadade@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Minal Harde |
| Designation |
Associate Professor |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Department of anaesthesiology
TNMC and BYL nair Hospital
mumbai Central
Nair Hospital
Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027137 |
| Fax |
|
| Email |
minalharde@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Bhadade |
| Designation |
Associate Professor |
| Affiliation |
Topiwala National Medical College and BYL Nair Ch Hospital |
| Address |
Department of Medicine
Nair Hospital
MAHARASHTRA
400008
India |
| Phone |
02223027122 |
| Fax |
|
| Email |
rakeshbhadade@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| TNMC BYL Nair Hospital
AL nair Road
Mumbai central
08 |
|
|
Primary Sponsor
|
| Name |
TNMC BYL Nair Hospital |
| Address |
TNMC BYL Nair Hospital
Mumbai |
| Type of Sponsor |
Government medical college |
|
|
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 Rakesh Bhadade |
Topiwala National Medical College and BYL Nair Ch Hospital |
Department of Medicine
TNMC BYL Nair Hospital
Mumbai
MAHARASHTRA |
02223027122
rakeshbhadade@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECARP Topiwala National Medical College and BYL Nair Ch 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, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
consecutive Covid-19 patients admitted during the study period will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
children less than 18 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All Covid -19 Patients will be stratified according to demographic parameters, clinical symptoms, co-morbidities, clinical course, laboratory, and radiological features, treatment given, ICU care, complications, and outcome (discharge or death). We aimed to compare the above parameters in different clinical outcomes. |
Death Or Discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome of covid 19 positive patients in terms of death or discharge from hospital |
Death or discharge of the patient |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
21/06/2020 |
| 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="1" |
|
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
|
To understand the pattern of covid-19 infection detailed clinical analysis is necessary. We therefore propose an observational study of all the patients admitted as COVID-19 infection positive in public infectious disease hospital. Patients will be stratified according to demographic parameters, clinical symptoms, co-morbidities, clinical course, laboratory, and radiological features, treatment given, ICU care, complications, and outcome (discharge or death). We aimed to compare the above parameters in different clinical outcomes. This study will help to create a standard protocol which will help in identifying high risk COVID-19 patients and standardizing management protocol and promptly treating patients in high risk groups which is fundamental to decrease the overall mortality rate. |