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

NCT04478019 | Completed Early Phase 1 DMC FDA Drug

• 4 other identifiers: 2020-0540A534265SMPH/MEDICINE/INFECT DISProtocol Version 6/1/2020
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV 2

Keywords

COVID-19; povidone-iodine; chlorhexidine gluconate; transmission; virology

Outcome Measures

Primary Outcomes (2)

• Number of Participants with COVID-19 diagnosis

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

  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.

  8 weeks

Secondary Outcomes (2)

• Fidelity of the treatment regimen

  8 weeks

• Feasibility of the treatment regimen

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

Study Arms (2)

Control > Active Intervention

OTHER

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

Active Intervention > Control

OTHER

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

Interventions

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

Active Intervention > Control; Control > Active Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 intervention

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: July 7, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be shared after enrollment goals are reached for this study. Data will be shared via this website and publication in peer-reviewed journals.

Locations

US (1)