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| Name | Class |
|---|---|
| Avrio Health | INDUSTRY |
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This study is a two-arm, randomized, 2-phase study. Phase I will be double blinded clinical trial of the safety and efficacy of an antiseptic mouthwash solution on reducing SARS-CoV-2 load in COVID 19+ adult individuals. Phase II is designed as an open label trial, and all subjects will receive the active mouthwash.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-iodine 0.5% antiseptic mouth rinse | Experimental | Subjects will be asked to rinse/gargle one time with 10 mL of Povidone-iodine 0.5% antiseptic mouth rinse for 30 seconds. |
|
| Placebo | Placebo Comparator | Subjects will be asked to rinse/gargle one time with 10 mL of placebo mouth rinse for 30 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouth rinse | Drug | Subjects will be asked to rinse/gargle one time with 10 mL of assigned mouth rinse for 30 seconds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| [PCR Saliva] Percent Change From Baseline Ct Viral Targets | 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)]. | 60 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| [PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| [Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens | 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. | 5, 30, and 60 minutes post intervention |
| [Nasal Swab] Log10 Antigens |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Corby, DDS, MS | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I |
| |||||||||||||
| Phase II (Open Label) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Povidone-iodine 0.5% Antiseptic Mouth Rinse | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | [PCR Saliva] Percent Change From Baseline Ct Viral Targets | 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)]. | 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. | Posted | Mean | 95% Confidence Interval | % Change from Baseline Cycle Threshold | 60 minutes after intervention |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Povidone-iodine 0.5% Antiseptic Mouth Rinse | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Our findings suggest that RT-PCR quantification of Ct viral targets present some limitations but can be of clinical utility. RT-PCR methods are inherently quantitative, and reproducible during repeated clinical sampling over a short time period. A limitation of our study was that changes in viral targets (RT-PCR) was determined after a one-time use of the mouthwash; prolonged use might yield better efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pat Corby | Penn Dental Medicine | 215-898-1162 | patcorby@upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2022 | Jul 10, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
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| 5 and 30 minutes post-intervention |
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. |
| 5, 30, 60 minutes post intervention |
| NOT COMPLETED |
|
|
| Placebo |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| (PCR Saliva) Ct Viral target Means (SD) at baseline | Higher mean "Cycle Threshold" represent lower SARS-Co-V-2 load, this is represented by CT RT-PCR values on an inverse correlation. PCR TRESHOLD: COVID-Seq requires specimen with Cycle Threshold values <30 to proceed - Cycle Threshold value >30 is considered negative. [Quick SARS-CoV-2 rRT-PCR Kit (Zymo Research, Cat. No. R3011)]. Three participants had non-evaluable baseline Cycle Threshold-values and were not included in analysis. | 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. | Mean | Standard Deviation | Cycle Threshold |
|
| [Oropharyngeal Swab] Log10 Antigens | Antigen analysis detects the viral antigen, or protein components of the virus (it can be associated with "Acute infection"). Microbubbling Digital Assay: TARGET N proteins from SARS-CoV-2 viruses. Output is the signal level that is given by nucleocapsid antigen in the samples when bound to antibodies. | Median | Inter-Quartile Range | Log10 Copies/mL |
|
| [Nasal Swab] Log10 Antigens | In the context of the study, the nasal antigen data was used to validate infectivity, as the site was not treated. Data show all subjects had strong antigen signals from nasal swab samples at all timepoints. Antigen analysis detects the viral antigen, or protein components of the virus (it can be associated with "Acute infection"). Microbubbling Digital Assay: TARGET N proteins from SARS-CoV-2 viruses. Output is the signal level that is given by nucleocapsid antigen in the samples when bound to antibodies. | Median | Inter-Quartile Range | Log10 Copies/mL |
|
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.
| OG001 | Placebo | 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. |
|
|
|
| Secondary | [PCR Saliva] Percent Change From Baseline Cycle Threshold at 5 and 30 Minutes Post Intervention | 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. | 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. | Posted | Mean | 95% Confidence Interval | % Change from Baseline Cycle Threshold | 5 and 30 minutes post-intervention |
|
|
|
|
| Other Pre-specified | [Oropharyngeal Swab] Percent Change From Baseline Log10 Antigens | 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. | Participants were randomized to Povidone-iodine or Placebo (saline) in a 1:1 ratio. | Posted | Median | Inter-Quartile Range | % Change from Baseline Median Log10 | 5, 30, and 60 minutes post intervention |
|
|
|
|
| Other Pre-specified | [Nasal Swab] Log10 Antigens | 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. | Participants were randomized to Povidone-iodine or Placebo (saline) in a 1:1 ratio. | Posted | Median | Inter-Quartile Range | % Change from Baseline Log10 Antigens | 5, 30, 60 minutes post intervention |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 40 |
| EG001 | Placebo | 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. | 0 | 20 | 0 | 20 | 0 | 40 |
| EG002 | Phase II - Open Label | 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. | 0 | 37 | 0 | 37 | 4 | 37 |
| Tingling Tongue | General disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.526 |
| Mean Difference (Net) |
| 2.5 |
| 2-Sided |
| 95 |
| -5.5 |
| 10.5 |
| Superiority |
| 60 minutes post intervention |
|
| 0.408 |
| Median Difference (Net) |
| 5.4 |
| 2-Sided |
| 95 |
| -10.7 |
| 18.6 |
| Superiority |
| Povidone-iodine: 60 minutes post-intervention | Signed Rank | 0.907 | Median Difference (Net) | -4.9 | 2-Sided | 95 | -15.2 | 17.5 | Superiority |
| Placebo: 5 minutes post intervention | Signed Rank | 0.008 | Median Difference (Net) | -2.4 | 2-Sided | 95 | -6.5 | -0.9 | Superiority |
| Placebo: 30 minutes post-intervention | Signed Rank | 0.080 | Median Difference (Net) | -6.6 | 2-Sided | 95 | -10.1 | -2.2 | Superiority |
| Placebo: 60 minutes post-intervention | Signed Rank | 0.001 | Median Difference (Net) | -8.6 | 2-Sided | 95 | -22.3 | -3.9 | Superiority |
| 60 minutes post intervention |
|
| 0.334 |
| Median Difference (Net) |
| 1.8 |
| 2-Sided |
| 95 |
| -2.3 |
| 6.9 |
| Superiority |
| Povidone-iodine 60 minutes post-intervention | Signed Rank | 0.269 | Median Difference (Net) | 1.5 | 2-Sided | 95 | -3.1 | 6.8 | Superiority |
| Placebo 5 minutes post-intervention | Signed Rank | 0.026 | Median Difference (Net) | -4.1 | 2-Sided | 95 | -7.1 | -0.7 | Superiority |
| Placebo 30 minutes post-intervention | Signed Rank | 0.182 | Median Difference (Net) | -0.7 | 2-Sided | 95 | -9.4 | 2.0 | Superiority |
| Placebo 60 minutes post-intervention | Signed Rank | 0.353 | Median Difference (Net) | -3.6 | 2-Sided | 95 | -7.7 | 4.0 | Superiority |