Back to resultsSHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding (SHIELD)
Primary Purpose
COVID-19, SARS-CoV 2
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, povidone-iodine, chlorhexidine gluconate, transmission, virology
Eligibility 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.
Sites / Locations
- University of Wisconsin-Madison
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control > Active Intervention
Active Intervention > Control
Arm 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 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).
Outcomes
Primary Outcome Measures
Number of Participants with COVID-19 diagnosis
Participants will be monitored for positive COVID-19 test results during this trial
SARS-Cov-2 Viral Load
Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04478019
First Posted
July 15, 2020
Last Updated
July 12, 2022
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04478019
Brief Title
SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding
Acronym
SHIELD
Official Title
Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV 2
Keywords
COVID-19, povidone-iodine, chlorhexidine gluconate, transmission, virology
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control > Active Intervention
Arm Type
Other
Arm 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.
Arm Title
Active Intervention > Control
Arm Type
Other
Arm 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).
Intervention Type
Drug
Intervention Name(s)
10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
Intervention Description
2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse
Primary Outcome Measure Information:
Title
Number of Participants with COVID-19 diagnosis
Description
Participants will be monitored for positive COVID-19 test results during this trial
Time Frame
8 weeks
Title
SARS-Cov-2 Viral Load
Description
Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Fidelity of the treatment regimen
Description
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.
Time Frame
8 weeks
Title
Feasibility of the treatment regimen
Description
A survey asking subjects to rank several factors that contribute to overall feasibility of use will be given pre- and post-intervention treatment.
Time Frame
2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding
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