Halodine Nasal Antiseptic in Patients With COVID-19

Halodine

Status and phase: Unknown; Phase 4

Conditions: SARS-CoV-2 Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04517188

HDN-N02-COV24A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Allergies to iodine-containing compounds

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Halodine Nasal Antiseptic

Experimental group

Description:

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

Treatment:

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