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Completed

NCT Number: NCT04478019

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse

Drug

2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Acronym: SHIELD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2020
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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