Halodine Nasal Antiseptic in Patients With COVID-19

Phase 4

• Conditions: SARS-CoV-2 Infection
• Interventions: Drug: Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP

• Registration Number: NCT04517188
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-08-15
• Study First Posted: 2020-08-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10
• Study Start: 2021-04-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Halodine Nasal Antiseptic	Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP	Povidone-Iodine Solution 1.25% w/w \[0.125% available iodine\] USP Single topical administration

Primary Outcome Measures

Name	Time	Method
Nasopharyngeal SARS-CoV-2 Viral Load	4 hours	Real-time reverse transcription (rRT)-PCR assay for SARS-CoV-2