COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients (PIIPPI)
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ClinicalTrials.gov Identifier: NCT04364802 |
Recruitment Status :
Recruiting
First Posted : April 28, 2020
Last Update Posted : June 7, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 SARS-CoV 2 | Drug: Povidone-Iodine Nasal Spray and Gargle | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Povidone-Iodine Intranasal for Prophylaxis in Front-line Health-care Personnel and Inpatients During the Sars-CoV-2 Pandemic |
Actual Study Start Date : | April 29, 2020 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
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No Intervention: Healthcare Workers - Control
Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.
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Experimental: Healthcare Workers - PVP-I
Front-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.
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Drug: Povidone-Iodine Nasal Spray and Gargle
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. |
No Intervention: Inpatients - Control
Inpatients 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.
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Experimental: Inpatients - PVP-I
Inpatients 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.
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Drug: Povidone-Iodine Nasal Spray and Gargle
Patients will receive standard of care treatment and a pre- and post-study nasal spray COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle shortly after admission or preoperatively. |
No Intervention: Community - Control
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
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Experimental: Community - PVP-I
Community 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.
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Drug: Povidone-Iodine Nasal Spray and Gargle
Community members will receive 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 home. |
- Percent of healthcare workers testing positive for COVID-19. [ Time Frame: 3 weeks ]Percent of healthcare workers that become positive for COVID-19 during the study.
- Percent of patients testing positive for COVID-9. [ Time Frame: 2 weeks ]Percent of patients that become positive for COVID-19 during the study.
- Percent of community participants testing positive for COVID-9. [ Time Frame: 3 weeks ]Percent of community participants that become positive for COVID-19 during the study.
- PVP-I Ease of Use [ Time Frame: 3 weeks ]Patients will rate the ease of use for PVP-I treatment on a scale from 1-5 after the initial use. Lower scores indicate increased ease of use (1="easy") while higher scores indicate increased difficulty (5="impossible").
- PVP-I Comfort [ Time Frame: 3 weeks ]Patients will rate the comfort of PVP-I treatment on a scale from 1-5 after the initial use. Lower scores indicate increased comfort (1="not so bad") while higher scores indicate discomfort (5="worst pain of my life").
- Adherence to treatment protocol [ Time Frame: 3 weeks ]Participants will fill out a daily questionaire assessing treatment frequency. Adherence will be calculated as the percent of correct dosing.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- positive for COVID19 by nasal swab
- symptomatic for COVID19
- unable to consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364802
Contact: Alexandra E Kejner, MD | 859-323-6741 | alexandra.kejner@uky.edu | |
Contact: Nikita Gupta, MD | 859-323-7351 | nikita.gupta@uky.edu |
United States, Kentucky | |
University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Alexandra E Kejner, MD 859-323-6741 alexandra.kejner@uky.edu | |
Contact: Nikta Gupta, MD 859-323-7351 nikita.gupta@uky.edu | |
Principal Investigator: Alexandra E Kejner, MD | |
Sub-Investigator: Nikita Gupta, MD | |
Sub-Investigator: Melissa Thompson-Bastin, PharmD | |
Sub-Investigator: James Porterfield, MD, PhD |
Principal Investigator: | Alexandra E Kejner, MD | Univesity of Kentucky |
Responsible Party: | Alexandra Kejner, Assistant Professor, University of Kentucky |
ClinicalTrials.gov Identifier: | NCT04364802 |
Other Study ID Numbers: |
58748 |
First Posted: | April 28, 2020 Key Record Dates |
Last Update Posted: | June 7, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
COVID-19 SARS-CoV 2 Health Care Workers COVID-19 Prophylaxis |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
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