SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding

Study Overview
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Brief Summary
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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.

Official Title
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Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study

Conditions
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COVID-19, SARS-CoV 2

Intervention / Treatment
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* Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control > Active Intervention<br>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<br>* 2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse<br>|
| Other: Active Intervention > Control<br>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<br>* 2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, povidone-iodine, chlorhexidine gluconate, transmission, virology