COVID-19, SARS-CoV 2
Conditions
Keywords
COVID-19, povidone-iodine, chlorhexidine gluconate, transmission, virology
Brief summary
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.
Interventions
DRUG10% 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
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant is a essential worker performing at least some in-person job duties (not 100% remote) * Participant is willing and able to perform intervention and data collection procedures. * Participant is able to provide informed consent in English language.
Exclusion criteria
* Diagnosis of COVID-19 within 2 months prior to enrollment, or active respiratory illness symptoms at time of enrollment * Known medical contraindication to chlorhexidine gluconate or povidone-iodine treatment ingredients (such as a known allergy) * Participant has a known medical and/or surgical reason prohibiting nasal swab sampling. * Participant is female who is pregnant, or believes she may be pregnant, at time of enrollment. * Participant is actively taking/using any treatments or interventions as part of any other COVID-19 related investigational trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with COVID-19 diagnosis | 8 weeks | Participants will be monitored for positive COVID-19 test results during this trial |
| SARS-Cov-2 Viral Load | 8 weeks | Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity of the treatment regimen | 8 weeks | 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. |
| Feasibility of the treatment regimen | 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention) | A survey asking subjects to rank several factors that contribute to overall feasibility of use will be given pre- and post-intervention treatment. |
Countries
United States
Outcome results
None listed