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NCT04517188 Clinical Trial

Halodine Nasal Antiseptic in Patients With COVID-19

SARS-CoV-2 Infection Clinical Trial

Official title:
A Phase 4 Study to Evaluate Nasopharyngeal SARS-CoV-2 Viral Shedding After Halodine Nasal Antiseptic in Patients With COVID-19

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04517188
Other study ID # HDN-N02-COV24A
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2021
Est. completion date July 1, 2021

Study information
Verified date February 2021
Source Halodine LLC
Contact Samuel B Barone, MD
Phone 2023908590
Email sbarone@halodine.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hospitalized with COVID-19 - Positive SARS-CoV-2 (rRT)-PCR within 48 hours of enrollment Exclusion Criteria: - Allergies to iodine-containing compounds

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Halodine LLC

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Nasopharyngeal SARS-CoV-2 Viral Load Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2 4 hours
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