Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000470998
Ethics application status
Approved
Date submitted
9/04/2020
Date registered
14/04/2020
Date last updated
12/10/2021
Date data sharing statement initially provided
14/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Virucidal pilot study of Nasodine® Antiseptic Nasal Spray (povidone-iodine 0.5%) in people with COVID-19 and confirmed nasal shedding of SARS-CoV-2 virus.
Scientific title
Virucidal pilot study of Nasodine® Antiseptic Nasal Spray (povidone-iodine 0.5%) in people with COVID-19 and confirmed nasal shedding of SARS-CoV-2 virus.
Secondary ID [1] 300971 0
Protocol Number FBP-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 Positive 317004 0
Condition category
Condition code
Infection 315167 315167 0 0
Other infectious diseases
Respiratory 315198 315198 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is an aqueous buffered solution of 0.5% povidone-iodine (PVP-I) contained in a 30 mL bottle closed with a traditional nasal spray pump.
Subjects will receive a single dose to their nasal passages, administered by the investigator.
The amount a subject receives consists of 6 x 140µL pump actuations (3 into each nostril), being 0.84 mL total volume.
Intervention code [1] 317298 0
Prevention
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323427 0
Impact of Nasodine on the reduction in virus in the nasal passages of subjects who are shedding the virus. Virus concentration is measured by PCR analysis of cell culture medium 96 hours after inoculation with a post-treatment nasal swab and compared to an equivalent culture inoculated with swab collected prior to treatment.
Timepoint [1] 323427 0
Endpoint is swab taken 5 minutes after dosing and compared against a swab taken 5 minutes prior to dosing.
Secondary outcome [1] 381912 0
Impact of Nasodine on the reduction in virus in the nasal passages of subjects who are shedding the virus. Virus concentration is measured by PCR analysis of cell culture medium 96 hours after inoculation with a post-treatment nasal swab and compared to an equivalent culture inoculated with swab collected prior to treatment.
Timepoint [1] 381912 0
Endpoint is swab taken 1 hour after dosing and compared against a swab taken 5 minutes prior to dosing.

Eligibility
Key inclusion criteria
Adult (18+ years old) patients with
(a) confirmed COVID-19 symptoms and
(b) symptom onset within the past five days.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known iodine sensitivity
• Previously diagnosed thyroid disease
• Previously diagnosed kidney disease
• Known to be pregnant or currently breastfeeding

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/04/2020
Actual
Date of last participant enrolment
Anticipated
1/05/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment outside Australia
Country [1] 24201 0
South Africa
State/province [1] 24201 0
Pretoria

Funding & Sponsors
Funding source category [1] 305418 0
Commercial sector/Industry
Name [1] 305418 0
Firebrick Pharma Pty Ltd
Country [1] 305418 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Firebrick Pharma Pty Ltd
Address
Level 9
440 Collins Street
Melbourne
VIC 3000
Country
Australia
Secondary sponsor category [1] 305809 0
None
Name [1] 305809 0
Address [1] 305809 0
Country [1] 305809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305739 0
Sire Charles Gairdner and Osborne Park Helath Care Group Human Research Ethics Committee
Ethics committee address [1] 305739 0
Sir Charles Gairdner Hospital
Level 2, A Block, Hospital Avenue, NEDLANDS WA 6009
Ethics committee country [1] 305739 0
Australia
Date submitted for ethics approval [1] 305739 0
12/03/2020
Approval date [1] 305739 0
28/04/2020
Ethics approval number [1] 305739 0

Summary
Brief summary
The primary purpose of this pilot study is to provide an indication that the in vitro disinfectant activity seen against the SARS-CoV-2 virus translates to disinfection of the nasal cavity in vivo of COVID-19 patients. Other objectives include collecting data to guide follow-on clinical studies and to provide insights as to mode of action. Overall, the study will provide important insights into the potential role for a PVP-I nasal spray in managing the risk of infection by the virus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101418 0
Prof Peter Friedland
Address 101418 0
Joondalup ENT
8/189 Lakeside Drive
Joondalup 6027
WA
Country 101418 0
Australia
Phone 101418 0
+61 0412137858
Fax 101418 0
Email 101418 0
[email protected]
Contact person for public queries
Name 101419 0
Prof Peter Friedland
Address 101419 0
Joondalup ENT
8/189 Lakeside Drive
Joondalup 6027
WA
Country 101419 0
Australia
Phone 101419 0
+61 0412137858
Fax 101419 0
Email 101419 0
[email protected]
Contact person for scientific queries
Name 101420 0
Prof Peter Friedland
Address 101420 0
Joondalup ENT
8/189 Lakeside Drive
Joondalup 6027
WA
Country 101420 0
Australia
Phone 101420 0
+61 0412137858
Fax 101420 0
Email 101420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plant to share data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIIn vivo (human) and in vitro inactivation of SARS-CoV-2 with 0.5% povidone-iodine nasal spray2022https://doi.org/10.21037/ajo-21-40
N.B. These documents automatically identified may not have been verified by the study sponsor.