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CTRI Number  CTRI/2020/06/025928 [Registered on: 16/06/2020] Trial Registered Prospectively
Last Modified On: 23/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Process of Care Changes 
Study Design  Other 
Public Title of Study   Local application of Povidone Iodine solution in nose and oral gargle for house hold contacts of COVID19 cases  
Scientific Title of Study   Povidone Iodine Gargle and Intranasal application: A Quasi-Experimental study to reduce the spread of coronavirus infection in community with Covid-19 positive clusters. 
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  Assoc.Prof 
Affiliation  Rangaraya Medical College 
Address  Rangaraya Medical College
Department of Plastic Surgery Pithampuram, Road, Kakinada
East Godavari
ANDHRA PRADESH
533001
India 
Phone  9848184495  
Fax    
Email  sum713@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumita Shankar 
Designation  Assoc.Prof 
Affiliation  Rangaraya Medical College 
Address  Rangaraya Medical College
Department of Plastic Surgery Pithampuram, Road, Kakinada
East Godavari
ANDHRA PRADESH
533001
India 
Phone  9848184495  
Fax    
Email  sum713@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivekanand Kattimani 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences  
Address  Sibar Institute of Dental Sciences, Guntur Post- Takkellapdu Mandalam- Pedakakani

Guntur
ANDHRA PRADESH
522509
India 
Phone  9492473628  
Fax    
Email  drvivekanandsk@gmail.com  
 
Source of Monetary or Material Support  
Dr Sumita Shankar, Department of Plastic Surgery Pithampuram, Road, Kakinada, Andhra Pradesh East Godavari ANDHRA PRADESH 533001 India 
 
Primary Sponsor  
Name  Dr Sumita Shankar 
Address  Department of Plastic Surgery Pithampuram, Road, Kakinada, Andhra Pradesh East Godavari ANDHRA PRADESH 533001 India 
Type of Sponsor  Other [Self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Rakesh Kakkar  Department of Community & Family Medicine All India Institute of Medical Sciences Mangalagiri, Temporary campus at Government Siddhartha Medical College, Vijayawada, Andhra Pradesh- 520008. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumita Shankar  Covid Clusters of Guntur Dist  Guntur Urban Area
Guntur
ANDHRA PRADESH 		 9848184495

sum713@yahoo.com 
Dr Limalemla Jamir  Covid Clusters of Krishna Dist  Vijayawada Urban area
Krishna
ANDHRA PRADESH 		 9914104152

lima.jamir@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC of All India Institute of Medical Sciences, Mangalagiri  Approved 
IEC of All India Institute of Medical Sciences, Mangalagiri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary and Secondary contacts of COVID19 positive patients  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Povidone Iodine  2% Povidone Iodine gargle diluted to 1% (w/v) is used as oropharyngeal gargle. 15 ml of diluted 1% (w/v) Povidone Iodine 4 times daily gargle at prescribed time and intranasal application- 4 times daily using 1% (w/v) Povidone Iodine using applicator tip. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1- Household (HH) contacts of laboratory confirmed COVID-19 case(s) (more than or equal to one case per HH)
2- Willing to carry out the procedures four times daily for 7 days if provided with the gargle solution.
3- Resident in the area for the last six months.
4- Persons willing to be part of this protocol and sign informed consent.



 
 
ExclusionCriteria 
Details  1- Allergy (hypersensitivity) to povidone iodine.
2- Currently have or have ever had a thyroid problem, including swelling.
3- Pregnant women and lactating mothers.
4- Persons who are unable to carry out the intervention due to intellectual disability.
5- Persons who are too ill to participate. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The Decrease in the attack rate of Primary and Secondary contacts of COVID19 patients and reduction of the Viral Load (Using cycle threshold values of RT PCR at different timelines)  7th day  
 
Secondary Outcome  
Outcome  TimePoints 
Early recovery from infection and no relapse of infection.  7th and 21 st day  
 
Target Sample Size   Total Sample Size="204"
Sample Size from India="204" 
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)   30/06/2020 
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)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The COVID-19 pandemic caused by SARS-CoV-2 virus has spread to 215 countries with 3,525,116 confirmed cases and 243,540 deaths1. As per the latest update by Ministry of Health and Family Welfare (MoHFW), Government of India, COVID-19 cases continue to rise in the country with 31967 active cases and the state of Andhra Pradesh has 1717 confirmed cases and 36 deaths as of May 5, 2020. A major administrative and public health concern is spread of COVID-19 in slum communities as overcrowding, lack of basic amenities, poor nutrition and ill health pose high risk of transmission and casualties to COVID-192,3. Moreover, most of the residents are low income groups who venture outside for daily wages or domestic work in peoples’ homes thereby further increasing the chances of overall spread4. As COVID-19 is transmitted via droplets, fomites and even fecal contamination, context based strategies need to be implemented to prevent spread within and outside vulnerable slum populations5,6. However, preventive measures advocated by the World Health Organization and national nodal bodies, MoHFW and Indian Council of Medical Research such as frequent hand washing, physical/social distancing and home isolation maybe practically impossible in such communities7,8. Additionally, SARS-CoV-2 is more transmissible in households than the earlier SARS-CoV and Middle East Respiratory Syndrome coronavirus (MERS-CoV)9. Highest risk exposure group are household contacts of COVID-19 cases and attack rate is reported to be higher among household and non-household family contacts than that in health care or other settings10. Transmission by infected persons even before symptom onset, prolonged viral shedding and overburdened health facilities necessitates early protection of household contacts where COVID-19 cases are present11,12.   In this context, Povidone Iodine (PVP-I), a widely used antiseptic in the healthcare setting with virucidal activity has the potential to contain the spread of COVID-19 from cases to household contacts. Rapid virucidal activity of Povidone Iodine (PVP-I) has been reported against Ebola virus (EBOV), the European reference virus (Modified vaccinia virus Ankara; MVA), MERS-CoV, influenza virus A (H1N1) and SARS coronavirus (SARS-CoV)13-15. In-vitro studies indicated that PVP-I products for gargling and spraying the throat inactivated the MERS-CoV, H1N1 virus and SARS-CoV in about 15 seconds to 2 minutes indicating the prophylactic role during outbreaks16. The recommended diagnostic testing for COVID-19 requires collection of nasopharyngeal and oropharyngeal swab specimens and higher viral load has been found in patient samples obtained from the nasopharynx than that those from the oropharynx17,18. Hence considering the routes of transmission which pose highest risk to close contacts, particularly among household contacts where other preventive measures mentioned earlier are difficult and healthcare staff who collect specimens for COVID-19 testing, PVP-I could serve as a protective barrier against SARS-CoV-2 virus. PVP-I is readily available in the market and intranasal application, oral gargles can be done easily by households and healthcare workers without any demanding procedures. Hence, the present study is aimed to assess the effectiveness of PVP-I in reduction of COVID-19 transmission from cases to household contacts. The study has significant policy level implications for community protection against COVID-19.         

References

1. World Health Organization. Coronavirus disease (COVID-19) Situation Report-106. May 5, 2020. Available from: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200505 covid-19-sitrep-106.pdf?sfvrsn=47090f63_2 [Last accessed on 2020 May 5].

2.   Ahmed F, Ahmed NE, Pissarides C, Stiglitz J. Why inequality could spread COVID-19. The Lancet Public Health 2020. doi: 10.1016/S2468-2667(20)30085-2 [Epub ahead of print].

3.   Krishnaiah K.“Tirupati City With Many Slums ; An Ill Health Environment To The Piligirim Centre” in Martin J. Bunch, V. Madha Suresh and T. Vasantha Kumaran, eds., Proceedings of the Third International Conference on Environment and Health, Chennai, India, 15-17 December, 2003. Chennai: Department of Geography, University of Madras and Faculty of Environmental Studies, York University. Pages 226 – 232.

 4.   Corburn J, Vlahov D, Mberu B, Riley L, Caiaffa WT, Rashid SF, et al. Slum Health: Arresting COVID-19 and Improving Well-Being in Urban Informal Settlements. J Urban Health 2020. doi: 10.1007/s11524-020-00438-6 [Epub ahead of print].

5.   World Health Organization. Coronavirus disease (COVID-19) advice for the public; 2019. Available from: https://www.who.int/ emergencies/diseases/novel-coronavirus-2019/ advice-for-public [Last accessed on 2020 May 4].

6.   GoI, MoH&FW, DGHS (EMR. Revised Guidelines on Clinical Management of COVID – 19[Internet]. 2020 [cited 2020 May 4]. Available from: https://www.mohfw.gov.in/ pdf/RevisedNationalClinicalManagementGuidelineforCOVID1931032020.pdf

7.   Xu Y, Li X, Zhu B, Liang H, Fang C, Gong Y et al. Characteristics of pediatric  SARS-CoV-2 infection and potential evidence for persistent fecal viral shedding. Nat Med 2020;26(4):502-505.

8.   van Doremalen N, Bushmaker T, Morris DH, Holbrook MG, Gamble A, Williamson BN, et al. Aerosol and surface stability of SARS-CoV-2 as compared with SARS-CoV-1. N Engl J Med 2020;382(16):1564-7.

9.   Jing QL, Liu MJ, Yuan J, Zhang ZB, Zhang AR, Dean NE, et al. Household Secondary Attack Rate of COVID-19 and Associated Determinants. medRxiv 2020.  doi.https://doi.org/ 10.1101/2020.04.11 .20056010d.

10.   Cheng HY, Jian SW, Liu DP, Ng TC, Huang WT, Lin HH. Contact Tracing Assessment of COVID-19 Transmission Dynamics in Taiwan and Risk at Different Exposure Periods Before and After Symptom Onset. JAMA Intern Med. 2020. doi: 10.1001/jamainternmed.2020.2020. [Epub ahead of print].

11.   Liu J, Liao X, Qian S, Yuan J, Wang F, Liu Y, et al. Community transmission of severe acute respiratory syndrome coronavirus 2, Shenzhen, China, 2020. Emerg Infect Dis 2020;26(6). doi: 10.3201/eid2606.200239. [Epub ahead of print].

12.   Wu Z, McGoogan JM. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the Chinese   Center for Disease Control and Prevention. JAMA. 2020;323 (13).   doi:10.1001/jama.2020.2648  [Epub ahead of print].

13.   Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology. 2006;212(Suppl. 1):119-23.

14.   Eggers M. Infectious Disease Management and Control with Povidone Iodine. Infectious diseases and therapy. 2019;1:1-3.

15.   Eggers M, Eickmann M, Zorn J. Rapid and effective virucidal activity of povidone-iodine products against Middle East respiratory syndrome coronavirus (MERS-CoV) and modified vaccinia virus ankara (MVA). Infect Dis Ther. 2015;4(4):491-501.

16.   Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018;7(2):249–59.

17.   Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. NEJM. 2020;382(12):1177-9. 

18.   To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, et al. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clinical Infectious Diseases. Oxford Academic. Clin Infect Dis     2019. Available from:https://academic.oup.com/cid/advancearticle/ doi/10.1093/ cid/ciaa149/5734265 [Last accessed on 2020 April 3, 2020].

 
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