| CTRI Number |
CTRI/2020/11/029388 [Registered on: 26/11/2020] Trial Registered Prospectively |
| Last Modified On: |
08/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Pirdal Nasal Spray in preventing symptomatic manifestation of disease in Covid-19 proven cases |
|
Scientific Title of Study
|
A Randomized, Multicentrique, Single-Blind, Observational Pilot Study To Evaluate Efficacy And Safety Of Pirdal Nasal Spray In Preventing Symptomatic Manifestation Of Disease In Covid-19 Proven Cases. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PIR/OBS/2020; Version No.: 4.0, Dated: 03/11/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai,
India
Mumbai (Suburban) MAHARASHTRA 400709 India |
| Phone |
|
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai,
India
MAHARASHTRA 400709 India |
| Phone |
|
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
Plot No 80, Sector 8, Koparkhairane Navi Mumbai,
India
MAHARASHTRA 400709 India |
| Phone |
|
| Fax |
|
| Email |
dr.sayalitarte@gmail.com |
|
|
Source of Monetary or Material Support
|
| VITROBIO SAS, ZAC de Lavaur 63500 Issoire, France |
|
|
Primary Sponsor
|
| Name |
VITROBIO SAS |
| Address |
ZAC de Lavaur 63500 Issoire, France |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
Plot No. 80, Sector - 8, Koparkhairane, Navi Mumbai-400709, Maharashtra, INDIA. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uma Mulay |
Orchid Hospital |
Department of Medicine, Room No. 2, 1st Floor, B Wing, Sector 18, Kamothe, India Mumbai (Suburban) MAHARASHTRA |
7738664583
drumamulay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Altezza Institutuional Ethics Committe, Shree Ashirwad Hospital, Dombivli, ,Maharshtra, India |
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 |
| Intervention |
PIRDAL Commercial name: “COVISPRAY® |
Indication: protecting and cleaning osmotic liquid nasal bandage to prevent respiratory distress.
(approx. 140 sprays).
Dose: 140 sprays
frequency route of administration: 2-3 sprays in each nostril
duration of therapy is 14 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Male or Female patients detected positive for Covid 19 by RT-PCR test and who have no or slight nasal /respiratory clinical signs at the time of recruitment.
2 The patients aged between 18-70 at the time of screening.
3 Patients who agreed not to self- medicate with other potential preventive ARI-antivirals. ï‚· Not currently symptomatic with an acute respiratory illness
4 Patients with Cooperative and understanding skills.
5 Patient willing to provide written informed consent.
6 Patient able to have internet access each day of the study to complete the online questionnaire
7 Patients ready to abstain from using any drug other than Investigational Product for the treatment of the studied condition, except in emergencies, in which case the responsible party must be immediately notified. Patients with moderate hypertension or diabetes may be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients, who will meet any of the exclusion criteria, will not be included in the study.
1 Hypersensitivity/History of allergy to any of the investigational products componants
2 Any recent nasal surgery
3 Abnormal structural narrowing of sinus passages such as Deviated Nasal Septum or other kind of anatomical obstruction
4 Any unstable, serious co-existing medical condition including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit
5 Clinical evidence of immunosuppression
6 Patient under treatment of viral disease
7 Patient with severe respiratory signs
8 Patients +ve for serum antibodies
9 Patients who have participated in other clinical studies less than 1 year prior to screening. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 To assess the change in the intensity of clinical symptoms (Nasal, general, coughing and respiratory) as per the Daily Questionnaire filled directly by the patients according to their randomization number
2 The following symptoms will be scored for each patient:
General: Fever, change in smell, taste appreciation, headache loss of taste, Nasal, Respiratory, Digestive
3 To assess the number of patients in each group developing minor or severe clinical signs |
From baseline to post randomization visit on days 7 and 14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of PIRDAL spray on the quality of life of patients using Quality of life Questionnaire (EQ-5D-3L). |
From baseline to post randomization visit on days 7 and 14. |
| Percentage of the patients reporting adverse events. |
From baseline to post randomization visit on days 7 to 14. |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="213" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2020 |
| Date of Study Completion (India) |
04/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical trial results in control (ST) patients receiving standard treatments showed a strong aggravation of the mean respiratory symptoms Leicester Cough Questionnaire (LCQ) and Visual analogue scale (VAS) parameters on days 1 and 2 followed by further slow deterioration up to day 4-6 and progressive improvement thereafter. In the test product group (TP, PIRDAL or Covispray), treated with osmotic polymeric nasal film, the respiratory symptoms did not aggravate on days 1 and 2 but remained stable up to day 5 followed by slow improvement, parallel to the ST group, up to day 14. The mean LCQ and VAS score difference between the TP and the ST groups was statistically significant (p<0.05) from day 1 onwards. The reason for this stabilization of respiratory symptoms immediately after the first treatment probably resides in the fact that the TP acts instantly by cleaning newly generated virus particles as well as inflammatory cytokines towards the film where they are trapped and inactivated by polymers. This mechanical cleaning minimizes cellular destruction and stimulates reconstruction of nasal mucosa. TP cleans only the free-floating nasal surface virus and protein molecules but has no effect on the intracellular and circulating virus particles which continue pouring onto the nasal surface and maintaining the infection for a few weeks. This explains why there is a sharp drop of Covid-19 clinical symptoms during the first 4-6 days, but further improvement is progressive and slow. The TP does not cure the disease but strongly reduces clinical symptoms right after the 1 st treatment. This approach minimizes the probability of developing severe respiratory symptoms. The intensity of fever, loss of sense of taste, small, and headache were also reduced in the TP compared to ST group right after the start of 1 st treatment. Being a mechanically acting, non-specific nasal surface cleaner, the test product should act against any Covid-19 viral mutant.
|