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

COVID-19 Clinical Trial

— SHIELD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04478019
• Other study ID #: 2020-0540
• Secondary ID: A534265SMPH/MEDI
• Status: Completed
• Phase: Early Phase 1
• Start date: July 7, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV 2

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with COVID-19 diagnosis	Participants will be monitored for positive COVID-19 test results during this trial	8 weeks
Primary	SARS-Cov-2 Viral Load	Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)