Halodine Nasal Antiseptic in Patients With COVID-19 | NCT04517188

Studies
Halodine Nasal Antiseptic in Patients With COVID-19

NCT04517188

Sponsor

Halodine LLC

Status

Unknown status

Last Update Posted

Feb 10, 2021Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

SARS-CoV-2 Infection

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2021Estimated

Primary Completion Date

Jul 1, 2021Estimated

Completion Date

Jul 1, 2021Estimated

First Submitted Date

Aug 15, 2020

First Submission Date that Met QC Criteria

Aug 15, 2020

First Posted Date

Aug 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2021

Last Update Posted Date

Feb 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Halodine Nasal Antiseptic	Experimental	Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP Single topical administration	Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP	Drug	Single topical administration	Halodine Nasal Antiseptic

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Allergies to iodine-containing compounds

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samuel B Barone, MD	Contact	2023908590		sbarone@halodine.com

Overall Officials

Name	Affiliation	Role
Samuel Barone, MD	Halodine LLC	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32511851	Background	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.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections