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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Halodine Nasal Antiseptic in Patients With COVID-19

NCT04517188

SARS-CoV-2 Infection

UNKNOWN PHASE4

Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus

NCT00539994

Infections, Bacterial

COMPLETED PHASE2

Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

NCT04435314

covid19

WITHDRAWN PHASE2

Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization

NCT02589067

S. Aureus Oropharyngeal Colonization

COMPLETED PHASE2

Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

NCT01081964

Community Acquired Pneumonia

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 SARS-CoV 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

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

Intervention Type DRUG

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

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).

Group Type OTHER

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes