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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.