COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients
PIIPPI
Povidone-Iodine Intranasal for Prophylaxis in Front-line Health-care Personnel and Inpatients During the Sars-CoV-2 Pandemic
1 other identifier
interventional
98
1 country
1
Brief Summary
Povidone-iodine (PVP-I) is a broad-spectrum antiseptic with activity against bacteria, fungi, and viruses. It has been previously used in both intranasal preparations against Methicillin Resistant Staphylococcus Aureus (MRSA) as well as oral preparations in in-vitro studies of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV), influenza H1N1, and rotavirus with good efficacy. This study will evaluate the efficacy of PVP-I as prophylaxis in Coronavirus Disease 2019 (COVID19)-negative front-line health care workers, hospital patients, and community members.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Apr 2020
Longer than P75 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedStudy Start
First participant enrolled
April 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2022
CompletedResults Posted
Study results publicly available
December 2, 2022
CompletedDecember 2, 2022
November 1, 2022
1.8 years
April 25, 2020
September 8, 2022
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percent of Healthcare Workers Testing Positive for COVID-19.
Percent of healthcare workers that become positive for COVID-19 during the study.
3 weeks
Percent of Patients Testing Positive for COVID-9.
Percent of patients that become positive for COVID-19 during the study.
2 weeks
Percent of Community Participants Testing Positive for COVID-9.
Percent of community participants that become positive for COVID-19 during the study.
3 weeks
Secondary Outcomes (2)
PVP-I Ease of Use
3 weeks
PVP-I Comfort
3 weeks
Other Outcomes (1)
Adherence to Treatment Protocol
3 weeks
Study Arms (6)
Healthcare Workers - Control
NO INTERVENTIONFront-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.
Healthcare Workers - PVP-I
EXPERIMENTALFront-line healthcare workers (FLCHW) who are negative for COVID-19 will receive standard PPE and a pre- and post-study test for COVID-19. Additionally, they will receive PVP-I spray and gargle.
Inpatients - Control
NO INTERVENTIONInpatients who have a 7+ day hospitalization or who are set to undergo a significant surgical procedure will receive standard care and a pre- and post-study COVID-19 test.
Inpatients - PVP-I
EXPERIMENTALInpatients who have a 7+ day hospitalization or who are set to undergo a significant surgical procedure will receive standard care and a pre- and post-study COVID-19 test. Additionally, they will receive PVP-I gargle and nasal sprays that will be applied shortly after admission or perioperatively.
Community - Control
NO INTERVENTIONCommunity participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
Community - PVP-I
EXPERIMENTALCommunity participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test. Additionally, they will receive PVP-I gargle and nasal sprays.
Interventions
Healthcare workers will receive standard PPE and a pre- and post-study nasal swab COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle (10% diluted 1:30) to use at the beginning of their shift, in the middle, and at the end of their shift.
Eligibility Criteria
You may qualify if:
- healthcare worker OR
- patient with expected hospital stay of 7+ days OR
- patient admitted for major surgery OR
- community member
- COVID19 negative by nasal swab test
- asymptomatic for COVID19
- able to consent
You may not qualify if:
- positive for COVID19 by nasal swab
- symptomatic for COVID19
- unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nikita Guptalead
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
Related Publications (1)
Burton MJ, Clarkson JE, Goulao B, Glenny AM, McBain AJ, Schilder AG, Webster KE, Worthington HV. Use of antimicrobial mouthwashes (gargling) and nasal sprays by healthcare workers to protect them when treating patients with suspected or confirmed COVID-19 infection. Cochrane Database Syst Rev. 2020 Sep 16;9(9):CD013626. doi: 10.1002/14651858.CD013626.pub2.
PMID: 32936949DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alexandra Kejner
- Organization
- University of Kentucky
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandra E Kejner, MD
Univesity of Kentucky
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 25, 2020
First Posted
April 28, 2020
Study Start
April 29, 2020
Primary Completion
January 28, 2022
Study Completion
January 28, 2022
Last Updated
December 2, 2022
Results First Posted
December 2, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share