Halodine Nasal Antiseptic in Patients With COVID-19

NCT ID: NCT04517188

Last Updated: 2021-02-10

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-07-01

Brief Summary

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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

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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.

Conditions

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SARS-CoV-2 Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Halodine Nasal Antiseptic

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

Single topical administration

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Single topical administration

Interventions

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

Single topical administration

Intervention Type DRUG

Other Intervention Names

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Halodine Nasal Antiseptic

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Allergies to iodine-containing compounds
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Halodine LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Barone, MD

Role: STUDY_DIRECTOR

Halodine LLC

Central Contacts

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Samuel B Barone, MD

Role: CONTACT

2023908590

References

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Bidra AS, Pelletier JS, Westover JB, Frank S, Brown SM, Tessema B. Rapid In-Vitro Inactivation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Using Povidone-Iodine Oral Antiseptic Rinse. J Prosthodont. 2020 Jul;29(6):529-533. doi: 10.1111/jopr.13209. Epub 2020 Jun 16.

Reference Type BACKGROUND
PMID: 32511851 (View on PubMed)

Related Links

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https://halodine.com/science/

Sponsor's Science Website

Other Identifiers

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HDN-N02-COV24A

Identifier Type: -

Identifier Source: org_study_id

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