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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV 2
• Intervention / Treatment: Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; povidone-iodine; transmission; chlorhexidine gluconate; virology
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: 2020-0540; A534265 (Other Identifier: UW Madison); SMPH/MEDICINE/INFECT DIS (Other Identifier: UW Madison); Protocol Version 6/1/2020 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified study results will be shared with other researchers.
• IPD Sharing Time Frame: Data will be shared after enrollment goals are reached for this study. Data will be shared via this website and publication in peer-reviewed journals.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes