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

University of Wisconsin (UW)

Status and phase: Completed; Early Phase 1

Conditions: COVID-19; SARS-CoV 2

Treatments: Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT04478019

SMPH/MEDICINE/INFECT DIS (Other Identifier)

A534265 (Other Identifier)

Protocol Version 6/1/2020 (Other Identifier)

2020-0540

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

Control > Active Intervention

Other group

Description:

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.

Treatment:

Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse

Active Intervention > Control

Other group

Description:

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).

Treatment:

Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse