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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  
Status 
Not Applicable 
 
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. 
 
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. 


 
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