Virucidal pilot study of Nasodine® (povidone-iodine 0.5%) nasal spray in people in South Africa with COVID-19 and confirmed nasal shedding of SARS-CoV-2 virus.

Phase 1

Completed

• Conditions: COVID-19 Positive; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621000034831
• Lead Sponsor: Firebrick Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-15
• Study Start: 2021-01-15
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Adult (18+ years old) patients with
(a) confirmed COVID-19 symptoms and
(b) symptom onset within the past five days.

Exclusion Criteria

• Known iodine sensitivity
• Previously diagnosed thyroid disease
• Previously diagnosed kidney disease
• Known to be pregnant or currently breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The titres of viable virus in mid-turbinate swab samples will be assessed by inoculation of Vero cells in tissue culture and measurement of viral RNA copies at 96 hours after inoculation. RT- PCR will be used to measure the number of RNA copies in serial dilution cell culture after 96 hours. The difference in growth between the baseline cell cultures and the Nasodine swabs taken post-treatment will be the measurable treatment effect. Specifically, the primary endpoint (EP) will be the reduction in growth between the baseline swab and the growth from the first swab taken 5 minutes after the Nasodine dose, (both assessed in cell culture after 96 hours).[The primary end point is the growth measured from the swab at 5 minutes after Nasodine dosing compared to the growth from the baseline swab.]

Secondary Outcome Measures

Name	Time	Method
Ongoing viral inactivation or viral recovery will be assessed by the collection of mid-turbinate swabs 60 minutes after the Nasodine treatment. The titre of viable virus in these mid-turbinate swab samples will be compared with the titre measured in the baseline samples and those collected 5 minutes after Nasodine treatment. [Secondary endpoint is the difference in titre between swabs collected before Nasodine treatment and those collected 60 minutes after treatment.<br>.]