| 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
|
|
|
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
|
|
|
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. |