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	Name  Address  NIL  NIL
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	Status  Not Applicable
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).