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Trial registered on ANZCTR


Registration number
ACTRN12621000034831
Ethics application status
Approved
Date submitted
29/11/2020
Date registered
15/01/2021
Date last updated
12/05/2023
Date data sharing statement initially provided
15/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 302894 0
Protocol Number FBP-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 Positive 319902 0
Condition category
Condition code
Infection 317838 317838 0 0
Other infectious diseases
Respiratory 317839 317839 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 8 x 140µL pump actuations (4 into each nostril), being 1.12 mL total volume.
Intervention code [1] 319180 0
Prevention
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325853 0
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).
Timepoint [1] 325853 0
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 [1] 390547 0
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.
Timepoint [1] 390547 0
Secondary endpoint is the difference in titre between swabs collected before Nasodine treatment and those collected 60 minutes after treatment.
.

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
Completed
Date of first participant enrolment
Anticipated
Actual
20/11/2020
Date of last participant enrolment
Anticipated
31/01/2021
Actual
15/12/2020
Date of last data collection
Anticipated
30/11/2021
Actual
15/12/2020
Sample size
Target
15
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 23232 0
South Africa
State/province [1] 23232 0
Pretoria

Funding & Sponsors
Funding source category [1] 307318 0
Commercial sector/Industry
Name [1] 307318 0
Firebrick Pharma Limited
Country [1] 307318 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Firebrick Pharma Limited
Address
Level 9
440 Collins Street
Melbourne
VIC 3000
Country
Australia
Secondary sponsor category [1] 307955 0
Commercial sector/Industry
Name [1] 307955 0
OnQ Research
Address [1] 307955 0
250 Market Street,
Fairland
Randburg 2190
South Africa
Country [1] 307955 0
South Africa

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307408 0
Pharma Ethics
Ethics committee address [1] 307408 0
123 Amkor Road
Lyttelton Manor Ext 3
Centurion 0157
South Africa
Ethics committee country [1] 307408 0
South Africa
Date submitted for ethics approval [1] 307408 0
Approval date [1] 307408 0
21/09/2020
Ethics approval number [1] 307408 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 in South Africa.
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 107130 0
Dr D de Jong
Address 107130 0
Jogaie Research,
Medicross Pretoria West, 1st Floor,
551 WF Nkomo Street
Pretoria 0183
South Africa
Country 107130 0
South Africa
Phone 107130 0
+27213275515
Fax 107130 0
Email 107130 0
[email protected]
Contact person for public queries
Name 107131 0
Sello Seeahloli
Address 107131 0
Medicross
250 Market Street
Fairland
Randburg 2190
South Africa
Country 107131 0
South Africa
Phone 107131 0
+274310763
Fax 107131 0
Email 107131 0
[email protected]
Contact person for scientific queries
Name 107132 0
Stephen Goodall
Address 107132 0
Firebrick Pharma Limited
Level 9
440 Collins Street
Melbourne 3000
Victoria
Country 107132 0
Australia
Phone 107132 0
+61 417 751 244
Fax 107132 0
Email 107132 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


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
No additional documents have been identified.