CTRI Number |
CTRI/2020/05/025487 [Registered on: 30/05/2020] Trial Registered Prospectively |
Last Modified On: |
06/09/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Case Control Study |
Study Design |
Other |
Public Title of Study
|
Development of Smell based test for identifying COVID-19 infection. |
Scientific Title of Study
|
Development of Sensory (Smell based) test to identify COVID-19 positive/negative/ at risk individuals. |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sanjay Kumar Bhadada |
Address |
Department of Endocrinology, PGIMER, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160014 India |
Phone |
9876602448 |
Fax |
|
Email |
bhadadask@rediffmail.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Mahendra Bishnoi |
Address |
NABI, Sector 81, Distt. Mohali, Punjab
Rupnagar PUNJAB 160055 India |
Phone |
|
Fax |
|
Email |
mbishnoi@gmail.com |
|
Details Contact Person Public Query
|
Name |
Dr Mahendra Bishnoi |
Address |
NABI, Sector 81, Distt. Mohali, Punjab
Rupnagar PUNJAB 160055 India |
Phone |
|
Fax |
|
Email |
mbishnoi@gmail.com |
|
Source of Monetary or Material Support
|
National Agri-Food Biotechnology Institute (NABI), Sector-81, Mohali, Punjab |
|
Primary Sponsor
|
Name |
National AgriFood Biotechnology Institute NABI |
Address |
Sector 81, Mohali, Punjab |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Prof Sanjay Bhadada |
Department of Endocrinology, PGIMER, Chandigarh |
COVID ward, Nehru Hospital Extension, PGIMER, Sector 12, Chandigarh.
And Research Block-B, PGIMER, Sec-12, Chandigarh. Chandigarh |
9876602448
bhadadask@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE, PGIMER, CHANDIGARH, INDIA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Coronavirus as the cause of diseases classified elsewhere |
Healthy Human Volunteers |
The quarentined subjects that will be COVID negative for the RT-PCR test, shall be considered as controls/ healthy. |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1. Symptomatic COVID19 positive patients, not critically ill or on ventilator, of any age/ sex and their relatives.
2. At risk individuals in quarantine (relatives and contact of positive individuals, symptomatic or asymptomatic) will also be recruited
3. As stated above sample size will be 300 initially irrespective of age/sex (no direct ratio) of the individuals
|
|
ExclusionCriteria |
Details |
1. Critically ill or on ventilator COVID19 positive patients, will be excluded.
2. The patients on a regular medication with probability of loss of smell and taste sensation will be excluded. Their history of any comorbidity which is related to smell sensation will be taken into account.
3. Those addicted to the chewing paan and similar materials will be excluded.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Economical, rapid, Make in India, a five-minute odor test that can present the identification, discrimination and thresholds of odor perceptions as a detection of suspected cases of COVID 19.
Sensory capabilities of COVID positive patients get damaged and thus can be used as tool of diagnosing infected / symptomatic COVID subjects |
The new diagnosed COVID positive cases will be tested will our odour test. Whereas those quarantined shall be monitored only after confirmation of their corona test report.
The odour test may be repeated on the recovered COVID patients either immediately or later. |
|
Secondary Outcome
|
Outcome |
TimePoints |
If we could do, the study may give correlation of genomic attributes of virus or mutations in relation to disease presentations. |
Such analysis will be conducted at approx 6th months or after the study |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
04/06/2020 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
Still there is no any publication from this work. It is a new study. |
Brief Summary
|
Rapid spread of the SARS-CoV-2 virus and concern
for viral transmission by ambulatory patients with minimal to no symptoms
underline the importance of identifying early or subclinical symptoms of
Covid-19 infection. Two such candidate symptoms include anecdotally reported
loss of smell (anosmia) and taste (ageusia). Available literature as well as
WHO guidelines have enumerated smell and taste loss as one of primary and
initial symptoms of infection.
Our group here at NABI is working on the sensory
receptors TRP channels since last 10 years with the question that how do we
sense food and what are its implications in obesity and type-2 diabetes. During
that time, we have been able to work with spices and herbs with unique and
characteristic odour. Using our understanding of chemosensory mechanisms, the
characteristic smell of herbs/spices commonly present in our kitchens and the
understanding that every Indian is aware of smell/odor of spices we will develop (economical, rapid, Make in
India) a five-minute odour test that can determine the identification,
discrimination and thresholds of odour perceptions (can be positively related
to taste loss) which on validation, may be an early indication of COVID-19.
Given the non-availability/expensive nature of testing kits, this test if
passed through will enable us do rapid and wider testing. In addition to this,
this test has a potential to be one of the scanning tests along with
temperature sensation (thermometer) at the entry points of hospitals,
government and private offices, shops and other places of public dealing in
order to have a safe cordon.
Diagnosis:
Recruitment of participants
- The patients already diagnosed positive for
COVID19 and are in PGIMER facility will be recruited for this study
whereas their healthy relatives or other normal individuals will be
screened for COVID19 by using confirmatory test through real-time PCR. For
supporting the study outcomes, the clinical samples and RNA samples can be
used for any genomic approach and association/ correlation with our test
results.
- At risk individuals in quarantine
(relatives and contact of positive individuals, symptomatic or
asymptomatic) will also be recruited. In their case, these will be
screened for COVID19 by using confirmatory test through real-time PCR.
This will enable us to correlate our smell test results with other symptoms.
In total 100 COVID19 positive individuals and
100 at risk quarantine will be recruited. Also, 100 healthy individuals
(COVID19 negative) will be recruited to understand that our smell panel is
easily detectable by normal healthy individuals.
Hence, study groups will be:
I.
COVID19 positive group (N=100).
II.
At risk quarantined individuals (N=100).
III.
Healthy individuals (negative for COVID19)
(N=100).
|