NCT04517188

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

August 15, 2020

Last Update Submit

February 8, 2021

Conditions

SARS-CoV-2 Infection

Keywords

Nasopharyngeal SARS-CoV-2 Viral Load

Outcome Measures

Primary Outcomes (1)

  • Nasopharyngeal SARS-CoV-2 Viral Load

    Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2

    4 hours

Study Arms (1)

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

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

Single topical administration

Also known as: Halodine Nasal Antiseptic
Halodine Nasal Antiseptic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergies to iodine-containing compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32511851BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Samuel Barone, MD

    Halodine LLC

    STUDY DIRECTOR

Central Study Contacts

Samuel B Barone, MD

CONTACT

2023908590sbarone@halodine.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 18, 2020

Study Start

April 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share