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

Location

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 Disease	Intervention/Treatment	Phase
COVID-19 SARS-CoV 2	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

Arm	Intervention/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

Arm

Intervention/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

Number of Participants with COVID-19 diagnosis [8 weeks]
Participants will be monitored for positive COVID-19 test results during this trial
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

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.
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.