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| ID | Type | Description | Link |
|---|---|---|---|
| A534265 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/INFECT DIS | Other Identifier | UW Madison | |
| Protocol Version 6/1/2020 | Other Identifier | UW Madison |
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Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel coronavirus is easily transmissable through close contact between individuals, especially during aerosol-generating procedures such as intubation of patients. The intervention proposed in this study (nasal and oral decontamination with povidone-iodine and chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention to be studied in this project may protect healthcare and other essential workers by preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the general public to essential worker,. and thus reducing the incidence of COVID-19 in these workers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control > Active Intervention | Other | Treatment is 3 weeks of standard personal protective equipment without any povidone-iodine (PI) or chlorhexidine gluconate (CHG) intervention (control), followed by a 2 weeks washout period, and 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures. |
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| Active Intervention > Control | Other | Treatment is 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures, followed by 2 weeks of washout, and 3 weeks of standard personal protective equipment without any PI or CHG intervention (control). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse | Drug | 2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with COVID-19 diagnosis | Participants will be monitored for positive COVID-19 test results during this trial | 8 weeks |
| SARS-Cov-2 Viral Load | Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity of the treatment regimen | Assessment of fidelity (as measured by percentage of compliance) to the treatment regimen will be measured by participants' reporting of intervention doses take through a daily treatment diary. | 8 weeks |
| Feasibility of the treatment regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
De-identified study results will be shared with other researchers.
Data will be shared after enrollment goals are reached for this study. Data will be shared via this website and publication in peer-reviewed journals.
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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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Two-period cross-over trial with a wash-out period between two study intervention periods. Participants will be randomized in a 1:1 ratio to two intervention sequences: active intervention followed by a no intervention control; or no intervention control followed by active intervention
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A survey asking subjects to rank several factors that contribute to overall feasibility of use will be given pre- and post-intervention treatment. |
| 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |