| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response (Others) - nil
- 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
- Who will be able to view these files?
Response (Others) - nil
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 10-01-2021 and end date provided 10-01-2022?
Response (Others) - nil
- 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
|