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CTRI Number  CTRI/2020/08/027465 [Registered on: 29/08/2020] Trial Registered Prospectively
Last Modified On: 10/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Nasal Wash and Gargle to Mitigate COVID-19 
Scientific Title of Study   Impact of Nasopharyngeal wash on Virion Load in COVID-19 Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  UDAY SANKAR CHATTERJEE 
Designation  Visiting Research Scholar 
Affiliation  MR Bangur Hospital,  
Address  Deshapran Shasmal Road, Tollygunge, Kolkata.
4, Gorky Terrace, Kolkata - 700017 Pediatric Surgery. Room No-608
Kolkata
WEST BENGAL
700033
India 
Phone  9831017686  
Fax    
Email  udaysankarchatterjee@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  UDAY SANKAR CHATTERJEE 
Designation  Visiting Research Scholar 
Affiliation  M.R. Bangur Hospital  
Address  241, Deshopran Shasmal Road,Tollygunge, Kolkata
4, Gorky Terrace, Kolkata - 700017 Pediatric Surgery. Room No-608
Kolkata
WEST BENGAL
700033
India 
Phone  9831017686  
Fax    
Email  udaysankarchatterjee@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  UDAY SANKAR CHATTERJEE 
Designation  Visiting Research Scholar 
Affiliation  M.R. Bangur Hospital 
Address  241, Deshopran Shasmal Road, Tollygunge, Kolkata
4, Gorky Terrace, Kolkata - 700017 Pediatric Surgery. Room No-608
Kolkata
WEST BENGAL
700033
India 
Phone  9831017686  
Fax    
Email  udaysankarchatterjee@yahoo.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Health Family Welfare Department Government of West Bengal 
Address  Swasthya Bhawan GN-29, Sector-V, Salt Lake, Kolkata - 700 091 
Type of Sponsor  Other [Ministry of Health] 
 
Details of Secondary Sponsor  
Name  Address 
MR Bangur Hospital  241,Deshapran Shasmal Road, Kolkata, Govt. of West Bengal  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sisir Naskar Superintendent  M R Bangur Hospital  241, Deshapran Shasmal Road, Tollygunge, Kolkata - 700033, Govt. of West Bengal
Kolkata
WEST BENGAL 
8240832513

sisir.sagnik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Post Graduate Medical Education & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Standard Treatment of COVID with Standard medications. No nasopharyngeal Wash.  
Intervention  Nasopharyngeal saline wash and shout gargle  Study group will be treated with Nasopharyngeal Saline wash along with Standard treatment for COVID 19 as follows. 1. Nasopharyngeal Wash with normal saline and pharyngeal SHOUT gargle with SALINE solution would be started as soon as the collection of nasopharyngeal swab for RT-PCR is completed. 2. Following that Nasopharyngeal Wash and pharyngeal SHOUT gargle would be continued for 48 hours: Daily in the morning evening and night. 3. Repeat collection of nasopharyngeal swab for RT-PCR to be done after 2 days in the morning 4 hours intermission from last nasopharyngeal wash and pharyngeal gargle. 4. Frequency of nasopharyngeal wash and pharyngeal gargle would be adjusted according to post-wash Virion Load. 5. Monitoring of biochemical, radiological parameters as per standard protocol would be continued both in control and in study group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Positive Patients of COVID-19  
 
ExclusionCriteria 
Details  Inability to perform nasopharyngeal saline wash 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction or absence of Virion Load in RT-PCR/ in patients of COVID-19 following nasopharyngeal wash would prevent Transmissibility, Severity and Fatality. Prophylactic Nasopharyngeal Wash with normal saline and pharyngeal gargle might prevent production of Virion Load that might avert COVID19 in population at large.   At Baseline, after 2days and after 4 days.  
 
Secondary Outcome  
Outcome  TimePoints 
Mitigation of Severity of COVID19   After 7days Changes in Clinical & Biochemical parameters (TLC, DLC, CRP, IL-6, )  
Decrease in Fatality  Number of patients transferred to Intensive care  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="251" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   04/09/2020 
Date of Study Completion (India) 05/01/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Preparing for Upload in Journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response (Others) -  nil

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  nil
  3. Who will be able to view these files?
    Response (Others) -  nil

  4. For what types of analyses will this data be available?
    Response (Others) -  nil

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 10-01-2021 and end date provided 10-01-2022?
    Response (Others) -  nil

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary
Modification(s)  

Background:

At the outset ‘External Virions’ replicate in Nasal epithelial cells and gradually creates load of ‘internal Virion’ in nasal cavity and pharynx as VMS (Virion-Mucus gel-Suspension). This Virion Load in VMS is the determining factor of length of Incubation period, Transmissibility of virions, Drug resistance, Severity and Fatality in COVID 19.

 Novelty:

At the outset, this COVID19 virions replicate in upper respiratory tract i.e. in naso-pharynx epithelium to produce the Virion Load necessary for further propagation and pathogenicity in Lung tissue. COVID19 virions replicate in superficial epithelial cells in nasal cavity not in any deeper tissues unlike HIV, Dengue and other virions. Therefore it is in our easy reach to wash out those virions from nasopharynx. This similar procedure is not possible for HIV, Dengue and other virions.

 Objectives:

 In this Therapeutic Trial we would like to wash the Nasopharynx with saline water and gargle with antimicrobial solution to wash out or decrease the Virion Load in VMS.

 Methods:

1. Nasopharyngeal Wash with normal saline and pharyngeal gargle with antimicrobial solution would be started as soon as the collection of nasopharyngeal swab is done.

2.   Following that Nasopharyngeal Wash and pharyngeal gargle would be continued for 48 hours: Daily in the morning and night.

3.   Repeat collection of nasopharyngeal swab for RT-PCR to be done after 2 days in the morning 12 hours intermission from last nasopharyngeal wash and pharyngeal gargle.

4. Frequency of nasopharyngeal wash and pharyngeal gargle would be adjusted according to post-wash Virion Load.

5. Monitoring of biochemical, radiological parameters as per standard protocol would be continued both in control and in study group.

   Expected Outcomes:

Reduced Virion Load in VMS in patients of COVID-19 would prevent Transmissibility, Severity and Fatality. Prophylactic Nasopharyngeal Wash with normal saline and pharyngeal gargle might prevent production of Virion Load that might avert COVID19 in population at large 




 
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