Halodine Nasal Antiseptic in Patients With COVID-19

A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04517188

Enrollment

Registered

2020-08-18

Start date

2021-04-01

Completion date

2021-07-01

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 Infection

Keywords

Nasopharyngeal SARS-CoV-2 Viral Load

Brief summary

Povidone iodine (PVP-I) is a well-known broad spectrum, resistance free antimicrobial agent that has a long history of safe and effective use. Halodine Nasal Antiseptic is formulated for topical application PVP-I to nasal passages, and has demonstrated effectiveness against SARS-COV-2 in vitro - 99.99% inactivation within 15 seconds. This study will evaluate the ability of Halodine Nasal Antiseptic to impact SARS-CoV-2 in vivo.

Detailed description

This is a multicenter, phase 4 prospective, single-cohort study in adult male and female volunteers hospitalized with COVID-19. Baseline nasopharyngeal swabs will be performed on all individuals. Halodine Nasal Antiseptic will then be applied to the anterior nares. Serial nasopharyngeal samples will then be collected at specified time points after the application. All samples will be tested for SARS-CoV-2 by real-time reverse transcription (rRT)-PCR assay.

Interventions

DRUGPovidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP

Single topical administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hospitalized with COVID-19 * Positive SARS-CoV-2 (rRT)-PCR within 48 hours of enrollment

Exclusion criteria

* Allergies to iodine-containing compounds

Design outcomes

Primary

Measure	Time frame	Description
Nasopharyngeal SARS-CoV-2 Viral Load	4 hours	Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2

Contacts

Primary ContactSamuel B Barone, MD

sbarone@halodine.com2023908590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026