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Halodine Nasal Antiseptic in Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04517188
Recruitment Status : Not yet recruiting
First Posted : August 18, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Halodine LLC

Tracking Information
First Submitted Date  ICMJE August 15, 2020
First Posted Date  ICMJE August 18, 2020
Last Update Posted Date February 10, 2021
Estimated Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2020)
Nasopharyngeal SARS-CoV-2 Viral Load [ Time Frame: 4 hours ]
Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Halodine Nasal Antiseptic in Patients With COVID-19
Official Title  ICMJE A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2 Infection
Intervention  ICMJE Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP
Single topical administration
Other Name: Halodine Nasal Antiseptic
Study Arms  ICMJE Experimental: Halodine Nasal Antiseptic

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

Single topical administration

Intervention: Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergies to iodine-containing compounds
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samuel B Barone, MD 2023908590 sbarone@halodine.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04517188
Other Study ID Numbers  ICMJE HDN-N02-COV24A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Halodine LLC
Study Sponsor  ICMJE Halodine LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Samuel Barone, MD Halodine LLC
PRS Account Halodine LLC
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP