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CTRI Number  CTRI/2020/09/028084 [Registered on: 28/09/2020] Trial Registered Prospectively
Last Modified On: 26/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effects of Traditional Nasal Saline (Simply Saline) and a Novel Nasal Salt on Aerosol Cleansing  
Scientific Title of Study   Nasal Calcium Salts for Clearing Exhaled Bioaerosols in healthy volunteers and in asymptomatic and midly symptomatic SARS COV 2 patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Carolin Elizabeth George 
Designation  Consultant 
Affiliation  Bangalore Baptist Hospital 
Address  Community Health Department 4th floor, Room No:01, Asha block, Bangalore Baptist Hospital Bellary road, Hebbal, Bengaluru

Bangalore
KARNATAKA
560024
India 
Phone  9972156838  
Fax    
Email  carolinelizabethj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Carolin Elizabeth George 
Designation  Consultant 
Affiliation  Bangalore Baptist Hospital 
Address  Community Health Department 4th floor, Room No:01, Asha block, Bangalore Baptist Hospital Bellary road, Hebbal, Bengaluru

Bangalore
KARNATAKA
560024
India 
Phone  9972156838  
Fax    
Email  carolinelizabethj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Carolin Elizabeth George 
Designation  Consultant 
Affiliation  Bangalore Baptist Hospital 
Address  Community Health Department 4th floor, Room No:01, Asha block, Bangalore Baptist Hospital Bellary road, Hebbal, Bengaluru

Bangalore
KARNATAKA
560024
India 
Phone  9972156838  
Fax    
Email  carolinelizabethj@gmail.com  
 
Source of Monetary or Material Support  
Azim Premji Foundation 134, Marathahalli - Sarjapur Rd, next to Wipro Corporate Office, Doddakannelli, Bengaluru, Karnataka 560035 
 
Primary Sponsor  
Name  Bangalore Baptist Hospital 
Address  Bangalore baptist hospital Bellary road, Hebbal Bengaluru-560024 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Carolin Elizabeth George  Bangalore Baptist Hospital  COVID ward and Research department Bangalore Baptist Hospital Bellary Road Hebbal
Bangalore
KARNATAKA 
9972156838

carolinelizabethj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Any person between 6 to 60 years 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasal mist calcium salts   100 mg through Nasal administration once for 5 minutes  
Comparator Agent  Normal Saline  100 mg through Nasal administration once for 5 minutes  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Phase1:
. Health care workers or the general public
. Willing for nasal spray treatment

Phase2:
Asymptomatic or mild COVID case with a Positive nasopharyngeal swab for SARS-Cov-2 (RT-PCR) not more than two weeks  
 
ExclusionCriteria 
Details  Phase1:
Any symptoms suggestive of SARS-Cov-2


Phase2:

. Nasal spray administered less than 12 hours
before the study
. active treatment with medications with a
known side effect of dry mouth
. current or prior mucosal head and neck
cancer treatment,
. acute or chronic upper aerodigestive tract
infection,
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Exhaled bioaerosol count (particles per liter of air)   Exhaled bioaerosol count (particles per liter of air)@ 15,30,45 minutes and 1Hr  
 
Secondary Outcome  
Outcome  TimePoints 
Nasal irritation  Nasal irritation @ 15,30,45 minutes and 1Hr  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   05/10/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Edwards D,Hickey A, Batycky R, Griel L,Lipp M,Dehaan W, Clarke R, et al.A New Natural Defense Against Airborne Pathogens.QRB Discovery. 2020; 1: e5. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study aims to compare the effects of nasal mist calcium salts to normal saline (Simply Saline Nasal Spray) on exhaled bioaerosol count (particles per liter of air) in healthy patients .  Studies conducted by Dr. David Edwards (Harvard Engineering) and his collaborators demonstrate that inhalation of mixed solutions of calcium chloride and sodium chloride reduce exhaled bioaerosol count in both animal and human studies.  Respiratory droplets and aerosols are the suspected mode of transmission for SARS-CoV-2.

The Coronavirus disease 2019 (COVID-19) is an unprecedented pandemic which has led to millions being affected and thousands dying every day across the world, including India.  Airborne infectious disease including COVID 19 transmits through the air by particles we exhale during natural breathing, most of these particles are less than a single micron in size, and not effectively filtered by conventional face masks.  Cleaning our airways of these particles is a hygienic measure that complements the wearing of face masks, the washing of hands, and social distancing, and can be of particular value in our current COVID-19 pandemic. A new product developed by Harvard Professor of the Practice of Biomedical Engineering David A. Edwards claims to be able to provide a nearly 100% reduction in the particles present in exhaled air — thus reducing the potential transmission of SARS-CoV-2 both into, and out of, the lungs while breathing. These scientists were looking ways to address the need for a broad prophylactic and anti-contagion defence against respiratory viral and bacterial infections for the last 15 years, using salt compositions to amplify natural antimicrobial defences of the respiratory system by incorporating three ions, all of which are abundant in human tissues: calcium, sodium and chloride.

 Initial studies showed promising benefits. Hypertonic calcium chloride and sodium chloride solution delivered to the respiratory system appears to have potential as both hygienic and therapeutic biodefense against airborne pathogens. Hygienically, these physiological salts coat the surfaces of airway lining fluid to diminish breakup and clear away the sub-micron bioaerosol droplets that are not effectively captured by masks. By potentially boosting natural immunological defences — strengthening the barrier function of the airway lining fluid and promoting the secretion of β-defensin 2 from nasal and bronchial epithelial tissues — these salts may also act therapeutically for antimicrobial prophylaxis or treatment. While our results suggest that calcium and sodium chloride salt combinations may be therapeutically useful against bacterial and viral infections including influenza, rhinovirus and pneumonia, the results point to an immediate hygienic value in the fight against any airborne infectious disease, including COVID-19, by cleaning the airways of the small airborne droplets that carry airborne infection.

We wanted to see the effectiveness of the same as it has the capability of rapid large-scale implementation. We propose to do two randomised control trials, the first one on apparently health volunteers to see whether the proposed intervention reduces the exhaled aerosol count (hygienic bio defence). In the second RCT, we would be looking for the therapeutic biodefence, the effect of the intervention on the SARS CoV 2 viral load.

 
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