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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 : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE July 15, 2020
First Posted Date  ICMJE July 20, 2020
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE July 7, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • Number of Participants with COVID-19 diagnosis [ Time Frame: 8 weeks ]
    Participants will be monitored for positive COVID-19 test results during this trial
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding
Official Title  ICMJE Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • COVID-19
  • SARS-CoV 2
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 10% Povidone-iodine nasal decolonization swab plus 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).
    Intervention: Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2021)
250
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)
94
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Joseph Perzynski, MSW 608-262-6560 jdperzyn@medicine.wisc.edu
Contact: Shelly Zimbric 608-265-8799 mzimbric@medicine.wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04478019
Other Study ID Numbers  ICMJE 2020-0540
A534265 ( Other Identifier: UW Madison )
SMPH/MEDICINE/INFECT DIS ( Other Identifier: UW Madison )
Protocol Version 6/1/2020 ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified study results will be shared with other researchers.
Supporting Materials: Study Protocol
Supporting Materials: 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.
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Wisconsin, Madison
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP