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CTRI Number  CTRI/2020/05/024962 [Registered on: 01/05/2020] Trial Registered Prospectively
Last Modified On: 07/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The use of topical Povidone Iodine (PVP-I) oropharyngeal and intranasal application during the current coronavirus pandemic as a potential measure to reduce viral transmission 
Scientific Title of Study   Effectiveness of topical povidone iodine (PVP-I) oropharyngeal and intranasal application during the current coronavirus pandemic amongst COVID-19 positive patients in Andhra Pradesh, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumita Shankar 
Designation  Associate Professor 
Affiliation  Rangaraya Medical College 
Address  Department of Plastic Surgery Pithampuram, Road, Kakinada, Andhra Pradesh

East Godavari
ANDHRA PRADESH
533001
India 
Phone  9848184495  
Fax    
Email  sum713@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sumita Shankar 
Designation  Associate Professor 
Affiliation  Rangaraya Medical College 
Address  Department of Plastic Surgery Pithampuram, Road, Kakinada, Andhra Pradesh

East Godavari
ANDHRA PRADESH
533001
India 
Phone  9848184495  
Fax    
Email  sum713@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sumita Shankar 
Designation  Associate Professor 
Affiliation  Rangaraya Medical College 
Address  Department of Plastic Surgery Pithampuram, Road, Kakinada, Andhra Pradesh

East Godavari
ANDHRA PRADESH
533001
India 
Phone  9848184495  
Fax    
Email  sum713@yahoo.com  
 
Source of Monetary or Material Support  
Mr. Anil kumar Assistant Director, Drugs Control Administration, 25-15-116/1B,Second Floor, Chuttugunta, Guntur District 522004.  
 
Primary Sponsor  
Name  WIN MEDICARE PVTLTD  
Address  ..WIN- MEDICARE PVT.LTD DNo 594-17-5/1-1, Madhav Nivas, Teacher colony, Vijayawada 5200006.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumita Shankar  All India Institute of Medical Sciences for Rangaraya Medical college  AIIMS, Mangalagiri, Andhra Pradesh 522503
Guntur
ANDHRA PRADESH 
9848184495

sum713@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Mangalagiri for Ranagarya Medical College, Kakinada  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  normal saline  48 patients laboratory tested COVID-19 positive selected and tested on 7th and 21st day for comparison and followed for 12 weeks to check for any relapse 
Intervention  Povidone Iodine  2% Povidone Iodine gargle diluted to 1% (w/v) is used as oropharyngeal gargle and intranasal application given 4 times to 48 laboratory tested COVID-19 patients and followed up for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients laboratory tested COVID-19 positive above 18 years of age +/- two days of admission 
 
ExclusionCriteria 
Details  Known allergy to povidone iodine or iodine
thyroid disorders
pregnancy
patients on Lithium therapy
patients on respiratory distress / unconscious / on ventilator 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
comparing the reduction in the progression, transmission of disease in 48 participants taking oropharyngeal gargles and intranasal application of PVP-I in comparison to the control group not doing the same for which patients in both the group will be tested for viral load on 7 th and 21 st day. Spread of the disease can be checked by confirming if the nasal / oropharyngeryngel swabs turn negative and no contacts turn covid-19 positive   The study group will be tested for covid-19 to check for negativity on & 7th and 21st day following intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Early recovery from infection and no relapse of infection. patients will be tested on 7th day and 21st day to confirm if they have turned negative . early negative will be an indicative of early recovery. Also even if any of the patients have co morbid factors and they do not turn serious that will suggest that disease progression is controlled  12 to 14 weeks 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   05/05/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Brief Summary  


Introduction:

The ongoing Covid-19 pandemic necessitates measures to prevent transmission and improve patient outcomes. Several studies demonstrated rapid virucidal activity of povidone iodine (PVP-I) against Ebola virus (EBOV), the Middle East Respiratory Syndrome coronavirus (MERS-CoV), influenza virus A (H1N1) and SARS coronavirus (SARS-CoV).

Objectives:

To assess the effectiveness of PVP-I 1% oropharyngeal and intranasal application in COVID 19 positive patients.

1. In reducing disease progression, complications such as respiratory distress / Death, relapse of

    infection following discharge.

2. In reducing the transmission to health workers attending to them in quarantine facility and other contacts.

Methods:

The study is proposed in all district of Andhra Pradesh,India. A two arm parallel group multicentric superiority clinical trial is proposed. COVID-19 positive patients admitted in quarantine and isolation wards attached to hospitals in the state of Andhra Pradesh, India. 

Inclusion Criteria: All COVID-19 positive patients aged 18 years and above. 

Exclusion Criteria: A known allergy/hypersensitive to Povidone Iodine.                                                                                                                                                  Any history of thyroid disorders                                                                                                                                                                               Unconscious patients; patients on ventilator.

Duration of the Study: 12-16 weeks.

Sample size calculation: It is estimated for a superiority clinical trial of two means (recovery time in days) in a parallel group design with equal allocation. Considering a superiority margin of 5%, mean recovery time in Group I (intervention) as 25 days, SD 16.6 days [Ref: Verity R et al]; mean recovery time of 7 days in Group II (no intervention); significance level set at 5% and power of 80%, the sample size is estimated to be 42 patients in each study group (Group I and Group II). Assuming a response rate of 85%, the sample size for each group is 48.3~ 48 patients. Hence, a total of 96 Covid-19 patients will be enrolled in the study. 

Sampling frame will be prepared from the hospital list of COVID-19 patients admitted in the study sites. Eligible patients identified will be enrolled serially until the desired sample size is attained for both groups.

Intervention: Self-administered oropharygeal and nasopharyngeal application of PVP-I 1%,. Procedures will be explained through video recorded demonstration. Minimal contact with patient will be maintained. 

Clinical end points: Seroconversion from COVID-19 positive to COVID-19 negative (testing day 7; day 21);.Minimal progression of disease in patients with associated comorbidities.

Recruitment: Mobile numbers will be collected from all COVID-19 positive patients in all the centres. Each participant will be given the participant information sheet (PIS) in the language which they understand and they will also be explained orally, the details of the information sheet. A pre-tested questionnaire in the local language (Telugu) will be administered to primary caregivers of the patients by trained health care personnel. The data regarding age, sex, weight, height, BMI (calculated), travel history,  known h/o contact with covid-19 positive patient or any other person with travel history, onset of symptoms such as fever, cough / rhinitis, respiratory symptoms, date of positive report, any associated comorbid factors such as overweight / mild, moderate or severe obesity (as per calculation of BMI), hypertension, diabetes, tuberculosis, asthma or any specific history which participant reveals. 

Informed written consent will be individually taken and documented. 

Baseline Investigations such as complete Blood picture, RBS, Blood Urea, Sr. Creatinine, C-Reactive protein will be documented. Any additional investigation done for participants with comorbid diseases will also be documented specifically. Baseline Serum Iodine and T3, T4, TSH will be done for all participants. In patients with respiratory symptoms X-ray chest and CT scan will also be taken. 

All the health care personnel assigned to the study group-1 will be informed about the study and will also be given training of oropharyngeal gargling and intranasal application of PVP-I 1%. They will be responsible for monitoring the proper use of the PVP-I solution with regard to quantity, technique and frequency. Each COVID-19 positive participant is required to repeat this procedure every 6 hourly i.e (5 AM, 11 AM, 5 PM and 11 PM) which will be also documented in record sheet and electronically. Each healthcare worker and other close contacts of the study group1 participant will also be given option to undertake the same procedure before they come for duty, before and after they leave the premises, after taking their informed written consent too.

Each participant will be followed up telephonically by the member of research group and any change in existing symptoms such as sore throat, fever, respiratory symptoms, diarrhea etc. The status quo or development of any new symptoms will be documented. Any participant showing worsening of symptoms due to disease spread in the form of respiratory distress or lowering of oxygen saturation, loss of consciousness and needing intubation and ventilatory support will be reported, documented and excluded from the study as per the exclusion criteria.

The remaining standard protocol as per the institutional and ICMR guidelines such as wearing of face masks and PPE and standard oral antiviral therapy will be continued and documented.

The disposal of the hazardous material generated will also be treated as per the standard guidelines. The instructions for the same will also be mentioned in the Information brochure.

Study group 2:

 

Similar details of identifying and collecting the phone numbers of the CoViD 19 positive participants will be done. The data regarding age, sex, weight, height, BMI ( calculated), travel history,  known h/o contact with covid-19 positive patient or any other person with travel history onset of symptoms such as fever, cough / rhinitis, respiratory symptoms, date of positive report, any associated comorbid factors such as overweight / mild, moderate or severe obesity (as per calculation of BMI), hypertension, diabetes, tuberculosis, asthma or any specific history which participant reveals.

Baseline Investigations such as complete Blood picture, RBS, Blood Urea, Sr. Creatinine, C reactive protein will be documented. Any additional investigation done for participants with comorbid diseases will also be documented specifically. Baseline Serum Iodine and T3, T4, TSH will be done for all participants. In   participant with respiratory symptoms, X-ray chest and CT  scan will be also taken .

The routine standard care procedure followed as per the institutions and ICMR guidelines will be continued. No healthcare worker will be encouraged to undertake this proposed prophylaxis

 


 
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