An Early Phase 1 interventional study of 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse in COVID-19 and SARS-CoV 2, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by University of Wisconsin, Madison · Early Phase 1, Interventional, and Prevention
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 245 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
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).
Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse
Number of Participants with COVID-19 diagnosis
Participants will be monitored for positive COVID-19 test results during this trial
Time frame: 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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
Feasibility of the treatment regimen
A survey asking subjects to rank several factors that contribute to overall feasibility of use will be given pre- and post-intervention treatment.
Time frame: 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)
Plan to share: Yes — De-identified study results will be shared with other researchers.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison