Halodine Nasal Antiseptic in Patients With COVID-19

Last updated: February 8, 2021
Sponsor: Halodine LLC
Overall Status: Active - Not Recruiting

Phase

4

Condition

Corona Virus

Treatment

N/A

Clinical Study ID

NCT04517188
HDN-N02-COV24A
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Allergies to iodine-containing compounds

Study Design

Total Participants: 40
Study Start date:
April 01, 2021
Estimated Completion Date:
July 01, 2021

Study 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.