Trial Outcomes & Findings for COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients (NCT NCT04364802)
NCT ID: NCT04364802
Last Updated: 2022-12-02
Results Overview
Percent of healthcare workers that become positive for COVID-19 during the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
3 weeks
Results posted on
2022-12-02
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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 - 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.
|
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.
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 - Control
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
|
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.
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 Study
STARTED
|
11
|
38
|
17
|
14
|
2
|
16
|
|
Overall Study
COMPLETED
|
11
|
38
|
17
|
14
|
2
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19: Povidone-Iodine Intranasal Prophylaxis in Front-line Healthcare Personnel and Inpatients
Baseline characteristics by cohort
| Measure |
Healthcare Workers - Control
n=11 Participants
Front-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
n=38 Participants
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 - Control
n=17 Participants
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 - PVP-I
n=14 Participants
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 - Control
n=2 Participants
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
|
Community - PVP-I
n=16 Participants
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
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Age
|
36 years
n=5 Participants
|
41 years
n=7 Participants
|
60 years
n=5 Participants
|
64 years
n=4 Participants
|
61 years
n=21 Participants
|
43 years
n=10 Participants
|
49 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
50 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
89 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
86 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
38 participants
n=7 Participants
|
17 participants
n=5 Participants
|
14 participants
n=4 Participants
|
2 participants
n=21 Participants
|
16 participants
n=10 Participants
|
98 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: This outcome measure pertains only to the arms that include healthcare workers.
Percent of healthcare workers that become positive for COVID-19 during the study.
Outcome measures
| Measure |
Healthcare Workers - Control
n=11 Participants
Front-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
n=38 Participants
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 - 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.
|
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.
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 - Control
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
|
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.
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.
|
0 percentage of healthcare workers
|
0 percentage of healthcare workers
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Percentage of patients that become positive for COVID-19 during the study.
Percent of patients that become positive for COVID-19 during the study.
Outcome measures
| Measure |
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.
|
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.
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 - Control
n=17 Participants
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 - PVP-I
n=14 Participants
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 - Control
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
|
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.
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 Patients Testing Positive for COVID-9.
|
—
|
—
|
0 percentage of patients
|
0 percentage of patients
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Percent of community participants that become positive for COVID-19 during the study.
Percent of community participants that become positive for COVID-19 during the study.
Outcome measures
| Measure |
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.
|
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.
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 - 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.
|
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.
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 - Control
n=2 Participants
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
|
Community - PVP-I
n=16 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percent of Community Participants Testing Positive for COVID-9.
|
—
|
—
|
—
|
—
|
0 percentage of community participants
|
0 percentage of community participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Control groups did not receive PVP-I and therefore are excluded from the evaluation of "ease of use" of PVP-I.
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").
Outcome measures
| Measure |
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.
|
Healthcare Workers - PVP-I
n=38 Participants
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 - 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.
|
Inpatients - PVP-I
n=14 Participants
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 - Control
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
|
Community - PVP-I
n=16 Participants
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.
|
|---|---|---|---|---|---|---|
|
PVP-I Ease of Use
|
—
|
4.48 units on a scale
Standard Deviation 0.80
|
—
|
4.43 units on a scale
Standard Deviation 0.85
|
—
|
4.77 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: Control groups did not receive PVP-I and are therefore excluded from the analysis of "comfort" of PVP-I
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").
Outcome measures
| Measure |
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.
|
Healthcare Workers - PVP-I
n=38 Participants
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 - 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.
|
Inpatients - PVP-I
n=14 Participants
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 - Control
Community participants who are negative for COVID-19 will receive a pre- and post-study COVID-19 test.
|
Community - PVP-I
n=16 Participants
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.
|
|---|---|---|---|---|---|---|
|
PVP-I Comfort
|
—
|
3.25 units on a scale
Standard Deviation 1.33
|
—
|
4.00 units on a scale
Standard Deviation 1.41
|
—
|
3.00 units on a scale
Standard Deviation 1.53
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksParticipants will fill out a daily questionaire assessing treatment frequency. Adherence will be calculated as the percent of correct dosing.
Outcome measures
Outcome data not reported
Adverse Events
Healthcare Workers - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthcare Workers - PVP-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inpatients - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inpatients - PVP-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community - Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community - PVP-I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place