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

Early Phase 1CompletedNCT04478019

University of Wisconsin, Madison245 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

245

Conditions

COVID-19 SARS-CoV 2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants with COVID-19 diagnosis

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

Time frame: 8 weeks

SARS-Cov-2 Viral Load

Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.

Time frame: 8 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

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.

Time frame: 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes