| CTRI Number |
CTRI/2020/08/027323 [Registered on: 23/08/2020] Trial Registered Prospectively |
| Last Modified On: |
23/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
A survey to collect vital parameters and symptoms of participants at risk of COVID19 |
|
Scientific Title of Study
|
Prospective Observational Study to Monitor Participants at risk of COVID 19 |
| Trial Acronym |
POMPCO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Yadav |
| Designation |
Director |
| Affiliation |
Kailash Hospital |
| Address |
2nd Floor,
Dept. of Pulmonology, OPD-2
Kailash Complex,
Productivity Road
Alkapuri
Vadodara
GUJARAT
390007
India |
| Phone |
91-265-2960601 |
| Fax |
91-265-2960601 |
| Email |
kailashhospital@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Yadav |
| Designation |
Director |
| Affiliation |
Kailash Hospital |
| Address |
2nd Floor,
Dept. of Pulmonology, OPD-2
Kailash Complex,
Productivity Road
Alkapuri
Vadodara
GUJARAT
390007
India |
| Phone |
91-265-2960601 |
| Fax |
91-265-2960601 |
| Email |
kailashhospital@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Patel |
| Designation |
Head- Clinical Research |
| Affiliation |
Rhythm Heart Institute |
| Address |
Rhythm Heart Institute
Near Siddharth Bunglows
Sama-Savli Road
Vadodara
GUJARAT
390022
India |
| Phone |
02652541006 |
| Fax |
02652541006 |
| Email |
pmeghacr@gmail.com |
|
|
Source of Monetary or Material Support
|
| INNOWEAR TECHNOLOGIES PRIVATE LIMITED |
|
|
Primary Sponsor
|
| Name |
INNOWEAR TECHNOLOGIES PRIVATE LIMITED |
| Address |
No. 745 10th Main
3rd Block 3rd stage
Basaveshwar Nagar
Bengaluru |
| Type of Sponsor |
Other [Wearable Device Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| INNOWEAR TECHNOLOGIES PRIVATE LIMITED |
No. 745 10th Main
3rd Block 3rd stage
Basaveshwar Nagar
Bengaluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manoj Yadav |
Kailash Hospital |
Productivity Road
Vadodara
Vadodara
GUJARAT |
91-265-2960601
91-265-2960601
kailashhospital@yahoo.com |
| Megha Patel |
Rhythm Heart Institute- A Unit of SLPL |
Sama Savli Road
Vadodara
Vadodara
GUJARAT |
91-265-2541006
91-265-2541006
pmeghacr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Rhythm Heart Institute Ethics Committee |
Approved |
| Rhythm Heart Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Persons at heightened risk of COVID-19 |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants at risk of COVID19
1.Household or Close contacts of COVID-19 cases
2.Staff working in COVID care centres
3.COVID-19 Hotspots
|
|
| ExclusionCriteria |
| Details |
1 Age less than 18 years and over 80 years
2 Previous COVID-19 treated case
3 Terminally ill patients
4 Patients with any debilitating disease at discretion of Principal investigator especially severe COPD, severe IHD, Malignancy etc
5 Patients on medicines affecting heart rate like betablockers
6 Immunocompromised subjects
7 Pregnant subjects
8 Unable to use Pulse oximeter and thermometer
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Early detection of COVID-19
|
At Baseline
At 2 weeks
At 3 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Regular health monitor
2. Detection of other diseases based on parameters measured
|
14 days |
|
|
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)
|
26/08/2020 |
| 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="0"
Months="0"
Days="30" |
|
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
|
|
This observational
study will collect information about vital parameters like monitoring
Sp02,
Heart rate, Fever & Cough in participants. The collected data,
along with the symptoms, will be used to build algorithms for a wearable
health device for early detection of Covid-19.
The wearable can also be later used
to detect other diseases using relevant algorithms
The information collected from the
wearable can also be used as health passport for travellers
|
|