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

Purpose

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.

Conditions

  • COVID-19
  • SARS-CoV 2

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
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
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Control > Active Intervention 		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
    2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse
Other
Active Intervention > Control 		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

Recruiting Locations

More Details

NCT ID
NCT04478019
Status
Completed
Sponsor
University of Wisconsin, Madison