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

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ClinicalTrials.gov Identifier: NCT04478019
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

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Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with COVID-19 diagnosis [ Time Frame: 8 weeks ]
    Participants will be monitored for positive COVID-19 test results during this trial

  2. SARS-Cov-2 Viral Load [ Time Frame: 8 weeks ]
    Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.


Secondary Outcome Measures :
  1. Fidelity of the treatment regimen [ Time Frame: 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.

  2. Feasibility of the treatment regimen [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478019


Contacts
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Contact: Joseph Perzynski, MSW 608-262-6560 jperzynski@medicine.wisc.edu
Contact: Shelly Zimbric 608-265-8799 mzimbric@medicine.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Kendra Haight, RN BSN    608-262-6560    klhaight@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04478019    
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 )
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified study results will be shared with other researchers.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
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.

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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
Keywords provided by University of Wisconsin, Madison:
COVID-19
povidone-iodine
chlorhexidine gluconate
transmission
virology
Additional relevant MeSH terms:
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Povidone-Iodine
Povidone
Plasma Substitutes
 Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents