| CTRI Number |
CTRI/2020/08/027169 [Registered on: 15/08/2020] Trial Registered Prospectively |
| Last Modified On: |
14/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Disease Profile of Covid-19 in patients admitted at AIIMS, Rishikesh |
|
Scientific Title of Study
|
To study the Disease Profileof Covid-19in patients at AIIMS, Rishikesh with focus on the demographical, clinical, laboratory, treatment, and outcome variables– a cross-sectional study (also known as ‘DPC19 – AIIMS Rishikesh’ study) |
| Trial Acronym |
DPC19 study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasan Kumar Panda |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of General Medicine, Sixth Floor, College Block, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9868999488 |
| Fax |
|
| Email |
prasan.med@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasan Kumar Panda |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of General Medicine, Sixth Floor, College Block, AIIMS Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9868999488 |
| Fax |
|
| Email |
prasan.med@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prasan Kumar Panda |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of General Medicine, Sixth Floor, College Block, AIIMS Rishikesh
UTTARANCHAL
249203
India |
| Phone |
9868999488 |
| Fax |
|
| Email |
prasan.med@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| Research cell, AIIMS, Rishikesh, Uttarakhand, India 249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Research cell, AIIMS, Rishikesh, Uttrarakhand, 249203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prasan Kumar Panda |
AIIMS |
Department of General Medicine, 6th floor, College block, AIIMS Rishieksh
Dehradun
UTTARANCHAL |
9868999488
prasan.med@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS Rishikesh |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All RT-PCR/Antigen lateral flow chromatographic immunoassay positive Covid-19 cases (Adult>18years) for next two years
2. Patient medical records available from April 2020 to present time for retrospective cohort
|
|
| ExclusionCriteria |
| Details |
1. Positive cases who have been admitted in other than Covid area where infectious disease reference has not been sorted |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Demographic details
2)Detailed History and physical examination findings
3)All laboratory investigations and imaging findings
4)Treatment and outcome details |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
25/08/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Justification for study: Covid-19 infection ispandemic now. It is an emerging infectious disease in many parts of the world.The presentation of the disease is highly variable. There are also regional differences in the clinical spectrum observed within India, probably due to antigenic variation of the organism and host factors. The treatment options for the disease are limited at present. Therefore, it is important to study the demographical factors contributing the disease occurrence, clinical presentations including their variability, laboratory details, treatment particulars, and outcomes of the Covid-19 in this region. This will improve the knowledge on this expanding clinical syndrome in our region.
Scope of the project:- This is intended to develop a preliminary Indian current data on the various aspects of course of illness of Covid-19.There seems to have a good scope to optimize and improve the existing practice in the current empirical antimicrobialera. The atypical manifestations will be described and predictors of mortality will be identified.Largely, the database of Covid-19 will be created for this region and it will help in planning many future studies. |