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

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04478019
Collaborator
(none)
245
Enrollment
1
Location
2
Arms
21.7
Anticipated Duration (Months)
11.3
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
245 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 interventionTwo-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 :
Jul 7, 2020
Anticipated Primary Completion Date :
Apr 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with COVID-19 diagnosis [8 weeks]

    Participants will be monitored for positive COVID-19 test results during this trial

  2. SARS-Cov-2 Viral Load [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

SiteCityStateCountryPostal Code
1University of Wisconsin-MadisonMadisonWisconsinUnited States53705

Sponsors and Collaborators

  • University of Wisconsin, Madison

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT04478019
Other Study ID Numbers:
  • 2020-0540
  • A534265
  • SMPH/MEDICINE/INFECT DIS
  • Protocol Version 6/1/2020
First Posted:
Jul 20, 2020
Last Update Posted:
Feb 17, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022