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
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
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
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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