| CTRI Number |
CTRI/2021/07/034624 [Registered on: 06/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [non alcoholic hand sanitizer] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of PROTECT-C hand sanitizer in SARS-CoV-2 infected subjects. |
|
Scientific Title of Study
|
A prospective open label clinical trial to evaluate the topical viral load reduction potential of PROTECT-C hand sanitizer on SARS-CoV-2 infected subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LMRC/CRD/21-22/001 Ver 1.0 dated 1st June 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VG Vaidya |
| Designation |
Managing Trustee |
| Affiliation |
Lokmanya Medical Research Centre |
| Address |
Second floor, OPD1, Covid ward, 314/B Telco Road, Chinchwad
Pune
MAHARASHTRA
411033
India
Pune
MAHARASHTRA
411033
India |
| Phone |
9822057766 |
| Fax |
|
| Email |
drvgvclinical@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MR SUDESH MARUTRAO ROKADE |
| Designation |
DIRECTOR |
| Affiliation |
MIYAKAWA KOGYO INDIA PVT LTD |
| Address |
2ND FLOOR PLOT NO 18 FINAL PLOT 106 RAMTEKDI INDUSTRIAL AREA HADAPSAR PUNE 411013
Pune
MAHARASHTRA
411013
India |
| Phone |
8888815766 |
| Fax |
|
| Email |
inquiry@miyakawa.co.in |
|
Details of Contact Person
Public Query
|
| Name |
MR SWAPNIL DIGHE |
| Designation |
STRATEGY MARKETING |
| Affiliation |
MIYAKAWA KOGYO INDIA PVT LTD |
| Address |
2ND FLOOR PLOT NO 18 FINAL PLOT 106 RAMTEKDI INDUSTRIAL AREA HADAPSAR PUNE 411013
Pune
MAHARASHTRA
411013
India |
| Phone |
9011058070 |
| Fax |
|
| Email |
swapnildighe@gmail.com |
|
|
Source of Monetary or Material Support
|
| MIYAKAWA KOGYO INDIA PVT LTD
2ND FLOOR PLOT NO 18 FINAL PLOT 106 RAMTEKDI INDUSTRIAL AREA HADAPSAR PUNE 411013 |
|
|
Primary Sponsor
|
| Name |
MIYAKAWA KOGYO INDIA PVT LTD |
| Address |
2ND FLOOR PLOT NO 18 FINAL PLOT 106 RAMTEKDI INDUSTRIAL AREA HADAPSAR PUNE 411013 |
| Type of Sponsor |
Other [Manufacturing Company] |
|
|
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 V G Vaidya |
Lokmanya Medical Research Centre |
Second floor, Covid ward, Lokmanya Hospital, 314/ B telco Road, Chinchwad
Pune
MAHARASHTRA |
9822057766
drvgvclinical@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Will ask patient to cough and sneeze on palms and will take the swab for RT-PCR as a control |
| Intervention |
PROTECT C Hand sanitizer spray
Stabilized chlorine dioxide solution |
Spray appropriate amount of PROTECT C hand sanitizer solution on palm, rub hands together, covering entire hand, including between fingers and keep it for 90 seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Tested SARS- CoV-2 positive within last 8 days of study enrolment.
Patients willing to sign written informed consent and are ready to comply to study procedure.
SARS-CoV-2 positive asymptomatic or symptomatic patients who are under institutional quarantine/ home isolated/ hospitalized.
|
|
| ExclusionCriteria |
| Details |
Patients on ventilator support. Pregnant or lactating woman. Subjects with history of sun burn on hands. Subjects with history of skin disorders or on medication for the same: Eczema, Urticaria, Psoriasis, Herpes, skin cancer, Lupus, Vitiligo, Fungal infection, Candidiasis. Subjects on treatment of any degree burns. Any kind of psychiatric disorder or a condition in the opinion of the investigator may hinder communication with the research team. Inability of the subject to cooperate or communicate with the research team and provide follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinically significant Quantitative Reduction of
80% Virus load from baseline to EOT. |
90 sec |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tolerability and safety of intervention |
90 sec |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/07/2021 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This new innovation works by destroying the virus with a unique Oxidation mechanism. This solution when sprayed gets activated on contact with air, providing a timely, powerful anti-bacterial oxidizing effect. The sterilizing mechanism generates reactive oxygen on contact with Viruses, Bacteria, and Fungi in the air or on objects, altering and destroying the virus. This is the background behind the research and innovation of the solution, with a brand name, PROTECT-C. PROTECT-C works by timely releasing chlorine dioxide solution, which sterilizes the virus and bacteria, through the action of an oxidation reaction, resulting in total annihilation of the virus. While the other standard sanitizing solutions available in the world today, use chlorine ions, which tend to release Chlorine gas, which is harmful to normal human cells and organs. Hence PROTECT-C has the potential to be used as a sanitizer in Covid 19. The current research is a validation of the potential of PROTECT C in covid 19 as a hand sanitizer. |