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Halodine Nasal Antiseptic in Patients With COVID-19

Primary Purpose

SARS-CoV-2 Infection

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP
Sponsored by
Halodine LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring Nasopharyngeal SARS-CoV-2 Viral Load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Halodine Nasal Antiseptic

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 15, 2020
    Last Updated
    February 8, 2021
    Sponsor
    Halodine LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04517188
    Brief Title
    Halodine Nasal Antiseptic in Patients With COVID-19
    Official Title
    A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    July 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Halodine LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SARS-CoV-2 Infection
    Keywords
    Nasopharyngeal SARS-CoV-2 Viral Load

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Halodine Nasal Antiseptic
    Arm Type
    Experimental
    Arm Description
    Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP Single topical administration
    Intervention Type
    Drug
    Intervention Name(s)
    Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP
    Other Intervention Name(s)
    Halodine Nasal Antiseptic
    Intervention Description
    Single topical administration
    Primary Outcome Measure Information:
    Title
    Nasopharyngeal SARS-CoV-2 Viral Load
    Description
    Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2
    Time Frame
    4 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samuel B Barone, MD
    Phone
    2023908590
    Email
    sbarone@halodine.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samuel Barone, MD
    Organizational Affiliation
    Halodine LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32511851
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://halodine.com/science/
    Description
    Sponsor's Science Website

    Learn more about this trial

    Halodine Nasal Antiseptic in Patients With COVID-19

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