COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients (PIIPPI)

• ClinicalTrials.gov Identifier: NCT04364802
• Recruitment Status: Completed
• First Posted: April 28, 2020
• Results First Posted: December 2, 2022
• Last Update Posted: December 2, 2022
• Sponsor: Nikita Gupta
• Information provided by (Responsible Party): Nikita Gupta, University of Kentucky

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Conditions: COVID-19; SARS-CoV 2
• Intervention: Drug: Povidone-Iodine Nasal Spray and Gargle
• Enrollment: 98

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
Arm/Group Description	Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.
Period Title: Overall Study
Started	11	38	17	14	2	16
Completed	11	38	17	14	2	16
Not Completed	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title		Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I	Total
Arm/Group Description		Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.	Total of all reporting groups
Overall Number of Baseline Participants		11	38	17	14	2	16	98
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Mean (Full Range); Unit of measure: Years
Age	Number Analyzed	11 participants	38 participants	17 participants	14 participants	2 participants	16 participants	98 participants
		36; (27 to 54)	41; (23 to 83)	60; (30 to 79)	64; (36 to 81)	61; (52 to 70)	43; (22 to 72)	49; (22 to 83)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	38 participants	17 participants	14 participants	2 participants	16 participants	98 participants
	Female	6 54.5%	20 52.6%	6 35.3%	5 35.7%	2 100.0%	9 56.3%	48 49.0%
	Male	5 45.5%	18 47.4%	11 64.7%	9 64.3%	0 0.0%	7 43.8%	50 51.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	38 participants	17 participants	14 participants	2 participants	16 participants	98 participants
	Hispanic or Latino	0 0.0%	1 2.6%	1 5.9%	0 0.0%	0 0.0%	2 12.5%	4 4.1%
	Not Hispanic or Latino	11 100.0%	35 92.1%	14 82.4%	14 100.0%	2 100.0%	13 81.3%	89 90.8%
	Unknown or Not Reported	0 0.0%	2 5.3%	2 11.8%	0 0.0%	0 0.0%	1 6.3%	5 5.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants	38 participants	17 participants	14 participants	2 participants	16 participants	98 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	5 13.2%	0 0.0%	0 0.0%	0 0.0%	1 6.3%	6 6.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 9.1%	1 2.6%	1 5.9%	0 0.0%	0 0.0%	0 0.0%	3 3.1%
	White	10 90.9%	30 78.9%	16 94.1%	14 100.0%	2 100.0%	14 87.5%	86 87.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 6.3%	1 1.0%
	Unknown or Not Reported	0 0.0%	2 5.3%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	2 2.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	11 participants	38 participants	17 participants	14 participants	2 participants	16 participants	98 participants
		11	38	17	14	2	16	98

Outcome Measures

1. Primary Outcome

Title	Percent of Healthcare Workers Testing Positive for COVID-19.
Description	Percent of healthcare workers that become positive for COVID-19 during the study.
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

This outcome measure pertains only to the arms that include healthcare workers.

Arm/Group Title	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
Arm/Group Description:	Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.
Overall Number of Participants Analyzed	11	38	0	0	0	0
Measure Type: Number; Unit of Measure: percentage of healthcare workers
	0	0

2. Primary Outcome

Title	Percent of Patients Testing Positive for COVID-9.
Description	Percent of patients that become positive for COVID-19 during the study.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

Percentage of patients that become positive for COVID-19 during the study.

Arm/Group Title	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
Arm/Group Description:	Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.
Overall Number of Participants Analyzed	0	0	17	14	0	0
Measure Type: Number; Unit of Measure: percentage of patients
			0	0

3. Primary Outcome

Title	Percent of Community Participants Testing Positive for COVID-9.
Description	Percent of community participants that become positive for COVID-19 during the study.
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Percent of community participants that become positive for COVID-19 during the study.

Arm/Group Title	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
Arm/Group Description:	Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.
Overall Number of Participants Analyzed	0	0	0	0	2	16
Measure Type: Number; Unit of Measure: percentage of community participants
					0	0

4. Secondary Outcome

Title	PVP-I Ease of Use
Description	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").
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Control groups did not receive PVP-I and therefore are excluded from the evaluation of "ease of use" of PVP-I.

Arm/Group Title	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
Arm/Group Description:	Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.
Overall Number of Participants Analyzed	0	38	0	14	0	16
Mean (Standard Deviation); Unit of Measure: units on a scale
		4.48 (0.80)		4.43 (0.85)		4.77 (0.44)

5. Secondary Outcome

Title	PVP-I Comfort
Description	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").
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

Control groups did not receive PVP-I and are therefore excluded from the analysis of "comfort" of PVP-I

Arm/Group Title	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
Arm/Group Description:	Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.
Overall Number of Participants Analyzed	0	38	0	14	0	16
Mean (Standard Deviation); Unit of Measure: units on a scale
		3.25 (1.33)		4.00 (1.41)		3.00 (1.53)

6. Other Pre-specified Outcome

Title	Adherence to Treatment Protocol
Description	Participants will fill out a daily questionaire assessing treatment frequency. Adherence will be calculated as the percent of correct dosing.
Time Frame	3 weeks

Outcome Measure Data Not Reported

Adverse Events

Time Frame	3 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
Arm/Group Description	Front-line healthcare workers (FLCHW) who are negative for COVID will receive standard PPE and a pre- and post-study test for COVID-19.	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. 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.	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.	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. 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.	Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.	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. 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.
All-Cause Mortality
	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/11 (0.00%)	0/38 (0.00%)	0/17 (0.00%)	0/14 (0.00%)	0/2 (0.00%)	0/16 (0.00%)
Serious Adverse Events
	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/11 (0.00%)	0/38 (0.00%)	0/17 (0.00%)	0/14 (0.00%)	0/2 (0.00%)	0/16 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Healthcare Workers - Control	Healthcare Workers - PVP-I	Inpatients - Control	Inpatients - PVP-I	Community - Control	Community - PVP-I
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/11 (0.00%)	0/38 (0.00%)	0/17 (0.00%)	0/14 (0.00%)	0/2 (0.00%)	0/16 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Alexandra Kejner
• Organization: University of Kentucky
• Phone: 859-323-6741
• EMail: aeke234@uky.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Nikita Gupta, University of Kentucky
• ClinicalTrials.gov Identifier: NCT04364802
• Other Study ID Numbers: 58748
• First Submitted: April 25, 2020
• First Posted: April 28, 2020
• Results First Submitted: September 8, 2022
• Results First Posted: December 2, 2022
• Last Update Posted: December 2, 2022