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

Early Phase 1

Completed

• Conditions: SARS-CoV 2; COVID-19
• Interventions: Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse

• Registration Number: NCT04478019
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-07
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Intervention > Control	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).
Control > Active Intervention	10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States