Clinical trial NCT04478019: SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding
Official title: Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: COVID-19
SARS-CoV 2
Keywords: COVID-19
povidone-iodine
chlorhexidine gluconate
transmission
virology
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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 intervention
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with COVID-19 diagnosis
timeFrame: 8 weeks
measure: SARS-Cov-2 Viral Load
timeFrame: 8 weeks
Secondary outcomes:
measure: Fidelity of the treatment regimen
timeFrame: 8 weeks
measure: Feasibility of the treatment regimen
timeFrame: 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References: