Trial Outcomes & Findings for Povidone-Iodine Oral Rinse Study (NCT NCT05239598)
NCT ID: NCT05239598
Last Updated: 2023-08-14
Results Overview
The primary endpoint is the percentage reduction of SARS-Co-V-2 load in saliva at 60 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicates a decrease from baseline SAR-Co-V2. \[Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)\].
COMPLETED
PHASE2
40 participants
60 minutes after intervention
2023-08-14
Participant Flow
Recruitment was from 2/7/2022 to 7/7/2022. Primary recruitment was through the University of Pennsylvania testing sites, community testing sites, and community partners. We also placed flyers/advertisements within our hospitals and dental clinics, including our community health centers outside the school, and relevant social media pages.
Participant milestones
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
Subjects were asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.
Mouth rinse: Subjects were asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
Placebo
Subjects were asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.
Mouth rinse: Subjects were asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
|---|---|---|
|
Phase I
STARTED
|
21
|
19
|
|
Phase I
COMPLETED
|
21
|
19
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
|
Phase II (Open Label)
STARTED
|
37
|
0
|
|
Phase II (Open Label)
COMPLETED
|
35
|
0
|
|
Phase II (Open Label)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
Subjects were asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.
Mouth rinse: Subjects were asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
Placebo
Subjects were asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.
Mouth rinse: Subjects were asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
|---|---|---|
|
Phase II (Open Label)
Lost to Follow-up
|
1
|
0
|
|
Phase II (Open Label)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
3 subjects (2 randomized to Povidone-iodine arm, and 1 randomized to Placebo) had non-evaluable baseline Cycle Threshold values and were not included in analysis.
Baseline characteristics by cohort
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
n=21 Participants
Subjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.
Mouth rinse: Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
Placebo
n=19 Participants
Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.
Mouth rinse: Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
16 Participants
n=21 Participants
|
12 Participants
n=19 Participants
|
28 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=21 Participants
|
7 Participants
n=19 Participants
|
12 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=21 Participants
|
19 Participants
n=19 Participants
|
39 Participants
n=40 Participants
|
|
Age, Continuous
|
30.6 Years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
32.4 Years
STANDARD_DEVIATION 12.3 • n=19 Participants
|
31.5 Years
STANDARD_DEVIATION 12.3 • n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=21 Participants
|
7 Participants
n=19 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=21 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=21 Participants
|
10 Participants
n=19 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=21 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=21 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=40 Participants
|
|
(PCR Saliva) Ct Viral target Means (SD) at baseline
|
26.6 Cycle Threshold
STANDARD_DEVIATION 4.7 • n=19 Participants • 3 subjects (2 randomized to Povidone-iodine arm, and 1 randomized to Placebo) had non-evaluable baseline Cycle Threshold values and were not included in analysis.
|
25.1 Cycle Threshold
STANDARD_DEVIATION 5.6 • n=18 Participants • 3 subjects (2 randomized to Povidone-iodine arm, and 1 randomized to Placebo) had non-evaluable baseline Cycle Threshold values and were not included in analysis.
|
25.9 Cycle Threshold
STANDARD_DEVIATION 5.1 • n=37 Participants • 3 subjects (2 randomized to Povidone-iodine arm, and 1 randomized to Placebo) had non-evaluable baseline Cycle Threshold values and were not included in analysis.
|
|
[Oropharyngeal Swab] Log10 Antigens
|
4.3 Log10 Copies/mL
n=21 Participants
|
4.2 Log10 Copies/mL
n=19 Participants
|
4.3 Log10 Copies/mL
n=40 Participants
|
|
[Nasal Swab] Log10 Antigens
|
6.2 Log10 Copies/mL
n=21 Participants
|
6.3 Log10 Copies/mL
n=19 Participants
|
6.2 Log10 Copies/mL
n=40 Participants
|
PRIMARY outcome
Timeframe: 60 minutes after interventionPopulation: Participants were randomized to Povidone-iodine or Placebo (saline) in a 1:1 ratio. Three participants had non-evaluable baseline Cycle Threshold-values and one value was missing at 60 minutes so they were excluded from the analysis of the outcome.
The primary endpoint is the percentage reduction of SARS-Co-V-2 load in saliva at 60 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicates a decrease from baseline SAR-Co-V2. \[Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)\].
Outcome measures
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
n=19 Participants
Subjects were asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
Placebo
n=17 Participants
Subjects were asked to rinse/gargle one time with 10 mL of placebo (saline) mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
|---|---|---|
|
[PCR Saliva] Percent Change From Baseline Ct Viral Targets
|
5.8 % Change from Baseline Cycle Threshold
Interval 0.8 to 10.7
|
1.3 % Change from Baseline Cycle Threshold
Interval -6.2 to 8.8
|
SECONDARY outcome
Timeframe: 5 and 30 minutes post-interventionPopulation: Participants were randomized to Povidone-iodine or Placebo (saline) in a 1:1 ratio. Three participants had non-evaluable baseline Ct-values so were excluded from the analysis of these secondary outcomes.
The secondary endpoints are the percentage reduction of SARS-Co-V-2 load in saliva at 5 and 30 minutes (post-intervention) compared to baseline between the PVP-I mouthwash versus the placebo mouthwash. For this outcome, Cycle Threshold is a proxy for SARS-Co-V-2 load. A positive percent change from baseline Cycle Threshold indicated a decrease from baseline SARS-Co-V-2.
Outcome measures
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
n=19 Participants
Subjects were asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
Placebo
n=18 Participants
Subjects were asked to rinse/gargle one time with 10 mL of placebo (saline) mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
|---|---|---|
|
[PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
5 minutes post intervention
|
3.3 % Change from Baseline Cycle Threshold
Interval -2.1 to 8.7
|
1.7 % Change from Baseline Cycle Threshold
Interval -3.0 to 6.3
|
|
[PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention
30 minutes post intervention
|
2.0 % Change from Baseline Cycle Threshold
Interval -2.5 to 6.5
|
-0.6 % Change from Baseline Cycle Threshold
Interval -7.6 to 6.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5, 30, and 60 minutes post interventionPopulation: Participants were randomized to Povidone-iodine or Placebo (saline) in a 1:1 ratio.
The secondary endpoints are the percentage reduction in SARS-Co-V-2 antigens obtained from oropharyngeal swab at 5, 30 and 60-minutes (post-intervention) compared to baseline within each treatment group.
Outcome measures
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
n=21 Participants
Subjects were asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
Placebo
n=19 Participants
Subjects were asked to rinse/gargle one time with 10 mL of placebo (saline) mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
|---|---|---|
|
[Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens
5 minutes post intervention
|
0.04 % Change from Baseline Median Log10
Interval -4.2 to 8.1
|
-2.4 % Change from Baseline Median Log10
Interval -6.5 to -0.9
|
|
[Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens
30 minutes post intervention
|
5.4 % Change from Baseline Median Log10
Interval -10.7 to 18.6
|
-6.6 % Change from Baseline Median Log10
Interval -10.1 to -2.2
|
|
[Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens
60 minutes post intervention
|
-4.9 % Change from Baseline Median Log10
Interval -15.2 to 17.5
|
-8.6 % Change from Baseline Median Log10
Interval -22.3 to -3.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5, 30, 60 minutes post interventionPopulation: Participants were randomized to Povidone-iodine or Placebo (saline) in a 1:1 ratio.
In the context of the study, the antigen data was used to validate infectivity, as this site was not treated. The pre-specified outcomes are the percentage reduction in SARS-Co-V-2 antigens obtained from nasal swab at 5, 30 and 60-minutes (post-intervention) compared to baseline within each treatment group.
Outcome measures
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
n=21 Participants
Subjects were asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
Placebo
n=19 Participants
Subjects were asked to rinse/gargle one time with 10 mL of placebo (saline) mouth rinse for 30 seconds. Saliva samples were obtained at baseline and at 5, 30, 60 minutes post intervention.
|
|---|---|---|
|
[Nasal Swab] Log10 Antigens
5 minutes post intervention
|
3.1 % Change from Baseline Log10 Antigens
Interval -2.2 to 5.8
|
-4.1 % Change from Baseline Log10 Antigens
Interval -7.1 to 0.7
|
|
[Nasal Swab] Log10 Antigens
30 minutes post intervention
|
1.8 % Change from Baseline Log10 Antigens
Interval -2.3 to 6.9
|
-0.7 % Change from Baseline Log10 Antigens
Interval -9.4 to 2.0
|
|
[Nasal Swab] Log10 Antigens
60 minutes post intervention
|
1.5 % Change from Baseline Log10 Antigens
Interval -3.1 to 6.8
|
-3.6 % Change from Baseline Log10 Antigens
Interval -7.7 to 4.0
|
Adverse Events
Povidone-iodine 0.5% Antiseptic Mouth Rinse
Placebo
Phase II - Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Povidone-iodine 0.5% Antiseptic Mouth Rinse
n=40 participants at risk；n=20 participants at risk
Subjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds.
Mouth rinse: Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
Placebo
n=40 participants at risk；n=20 participants at risk
Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds.
Mouth rinse: Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds.
|
Phase II - Open Label
n=37 participants at risk
All subjects in Phase II will be asked to use the Povidone-iodine 0.5% mouth rinse for 1 week. They will be asked to rinse/gargle with 10mL mouthwash for 30 seconds 4 times per day for 1 week.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/40 • Adverse events were recorded from the time of informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Note, no SAEs were reported.
|
0.00%
0/40 • Adverse events were recorded from the time of informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Note, no SAEs were reported.
|
5.4%
2/37 • Number of events 2 • Adverse events were recorded from the time of informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Note, no SAEs were reported.
|
|
General disorders
Tingling Tongue
|
0.00%
0/40 • Adverse events were recorded from the time of informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Note, no SAEs were reported.
|
0.00%
0/40 • Adverse events were recorded from the time of informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Note, no SAEs were reported.
|
5.4%
2/37 • Number of events 2 • Adverse events were recorded from the time of informed consent was obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Note, no SAEs were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place