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Halodine Nasal Antiseptic in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04517188
Recruitment Status : Not yet recruiting
First Posted : August 18, 2020
Last Update Posted : February 10, 2021
Information provided by (Responsible Party):
Halodine LLC

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Halodine Nasal Antiseptic

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
Single topical administration
Other Name: Halodine Nasal Antiseptic

Primary Outcome Measures :
  1. Nasopharyngeal SARS-CoV-2 Viral Load [ Time Frame: 4 hours ]
    Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergies to iodine-containing compounds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04517188

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Contact: Samuel B Barone, MD 2023908590 sbarone@halodine.com

Sponsors and Collaborators
Halodine LLC
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Study Director: Samuel Barone, MD Halodine LLC
Additional Information:
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Responsible Party: Halodine LLC
ClinicalTrials.gov Identifier: NCT04517188    
Other Study ID Numbers: HDN-N02-COV24A
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Halodine LLC:
Nasopharyngeal SARS-CoV-2 Viral Load
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes