South African National Clinical Trials Registry
South African Medical Research Council, Cochrane South Africa
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: sactradmin@mrc.ac.za Website: sanctr.samrc.ac.za
Trial no.: DOH-27-122020-6373 Date of Approval: 07/12/2020
Trial Status: Approved
TRIAL DESCRIPTION
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.
Official 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.
Brief summary describing the background and objectives of the trial Intervention is an aqueous bu ered 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.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) NA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied SARS - COV 02
Purpose of the trial Prevention
Anticipated trial start date 16/11/2020
Actual trial start date 16/11/2020
Anticipated date of last follow up 16/12/2020
Actual Last follow-up date 16/12/2020
Anticipated target sample size (number of participants) 15
Actual target sample size (number of participants) 15
Recruitment status Completed
Publication URL www.firebrickpharma.com
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nasodine antiseptic nasal spray. single dose single dose 4 pump activations in each nostril 15
Control Group Nasodine antiseptic nasal spray. Single Dose Single Dose 4 Pump activation in each nostril 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• adult (18+ years old) patients with (a) confirmed COVID-19 symptoms and (b) symptom onset within the past five days. Based on published data (Wang et al, 2020), • 12-13 participants are expected to provide nasal swabs with positive result for SARS-CoV-2 at baseline, i.e., the ITT population; patients who do not have positive baseline swabs will be excluded from the EP analysis. • Known iodine sensitivity • Previously-diagnosed thyroid disease • Known to be pregnant or currently breastfeeding Adult: 19 Year(s)-105 Year(s) 18 Year(s) 65 Year(s) Both
APPROVALS
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/09/2020 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road, Lyttelton Manor Ext 3, Centurion, 0157 Centurion 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/10/2020 SAHPRA
Ethics Committee Address
Street address City Postal code Country
CSIR Reception Building 38a Meiring Naudé Road Brummeria Pretoria Pretoria 0083 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 at 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 at 96 hours. 5 minutes
Secondary Outcome There are two exploratory endpoints. The first will be the same assessment as for the primary EP, but using the post-dose swab taken at 1 hour after the treatment. This will attempt to assess the extent to which Nasodine treatment has a residual impact on nasal shedding, beyond the first treatment, and may provide initial guidance on the frequency of treatment required. A second exploratory EP will be the PCR-detected viral RNA in each of the three post-dose swabs compared with the baseline viral RNA at baseline, prior to growth in tissue culture. This will assess the extent to which Nasodine affects RNA over time compared with its impact on the infectivity of the virus (as seen in the VIDRL study). 5 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr D de Jong Jogaie Research, Medicross Pretoria West, 1st Floor, 551 WF Nkomo Street pretoria 0183 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
FirebrickPharma Joondalup ENT, 8/189 Lakeside Drive Joondalup WA 6027 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stephen Goodall Firebrick Pharma Pty Ltd, Level 9, 440 Collins Street, Melbourne Victoria 3000 Australia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr D de Jong Jongaie Research, Medicross Pretoria West, 1st Floor, 551 WF Nkomo Street Pretoria 0183 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dr D de Jong Douwe douwe@lantic.net +27213275515 Jongaie Research, Medicross Pretoria west, 1st Floor, 551 WF Nkomo Street
City Postal code Country Position/Affiliation
Pretoria 0183 South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Dr Sello Seeahloli sellos@onqsa.co.za +274310763 250 Market Street, Fairland
City Postal code Country Position/Affiliation
Randburg 2190 South Africa Executive Director
Role Name Email Phone Street address
Scientific Enquiries Stephen Goodall sgoodall@firebrickpharma.com +61417751244 Firebrick Pharma Pty Ltd, Level 9, 440 Collins Street
City Postal code Country Position/Affiliation
Melbourne 3000 Australia Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Privacy statement included in the Informed consent Informed Consent Form,Study Protocol 12 months Control
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.firebrickpharma.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 30/11/2020 full public title A study to determine whether Nasodine spray reduces Coronavirus in the nose? Virucidal pilot study of Nasodine® Antiseptic Nasal Spray (povidone-iodine 0.5%) in people with COVID-19 and con rmed nasal shedding of SARS-CoV-2 virus.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 09/12/2020 error in title Virucidal pilot study of Nasodine® Antiseptic Nasal Spray (povidone-iodine 0.5%) in people with COVID-19 and con rmed nasal shedding of SARS-CoV-2 virus. 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.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 30/11/2020 full scientific title Virucidal pilot study of Nasodine® (povidone-iodine 0.5%) nasal spray in people with COVID-19 and confirmed nasal shedding of SARS-CoV-2 virus. Virucidal pilot study of Nasodine® Antiseptic Nasal Spray (povidone-iodine 0.5%) in people with COVID-19 and con rmed nasal shedding of SARS-CoV-2 virus.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 09/12/2020 error in title Virucidal pilot study of Nasodine® Antiseptic Nasal Spray (povidone-iodine 0.5%) in people with COVID-19 and con rmed nasal shedding of SARS-CoV-2 virus. 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.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 30/11/2020 brief description was missing xxxx Intervention is an aqueous bu ered 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.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 08/03/2021 from not yet recruiting to recruiting Active, not recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 31/08/2021 Trial Completed Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 01/12/2020 completed www.fi www.firebrickpharma.com
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 01/12/2020 Updated xxx • adult (18+ years old) patients with (a) confirmed COVID-19 symptoms and (b) symptom onset within the past five days. Based on published data (Wang et al, 2020), • 12-13 participants are expected to provide nasal swabs with positive result for SARS-CoV-2 at baseline, i.e., the ITT population; patients who do not have positive baseline swabs will be excluded from the EP analysis.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 01/12/2020 Updated xxx • Known iodine sensitivity • Previously-diagnosed thyroid disease • Known to be pregnant or currently breastfeeding
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 02/12/2020 Updated Time points Secondary Outcome, There are two exploratory endpoints. The first will be the same assessment as for the primary EP, but using the post-dose swab taken at 1 hour after the treatment. This will attempt to assess the extent to which Nasodine treatment has a residual impact on nasal shedding, beyond the first treatment, and may provide initial guidance on the frequency of treatment required. A second exploratory EP will be the PCR-detected viral RNA in each of the three post-dose swabs compared with the baseline viral RNA at baseline, prior to growth in tissue culture. This will assess the extent to which Nasodine affects RNA over time compared with its impact on the infectivity of the virus (as seen in the VIDRL study). , xxx Secondary Outcome, There are two exploratory endpoints. The first will be the same assessment as for the primary EP, but using the post-dose swab taken at 1 hour after the treatment. This will attempt to assess the extent to which Nasodine treatment has a residual impact on nasal shedding, beyond the first treatment, and may provide initial guidance on the frequency of treatment required. A second exploratory EP will be the PCR-detected viral RNA in each of the three post-dose swabs compared with the baseline viral RNA at baseline, prior to growth in tissue culture. This will assess the extent to which Nasodine affects RNA over time compared with its impact on the infectivity of the virus (as seen in the VIDRL study). , 5 minutes
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 02/12/2020 Updated Address FirebrickPharma, xxx, xx, xx, Australia, Commercial Sector / Industry, , 2.1 million, Primary Funder FirebrickPharma, Joondalup ENT, 8/189 Lakeside Drive, Joondalup WA, 6027, Australia, Commercial Sector / Industry, , 2.1 million, Primary Funder
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 02/12/2020 Updated Address Dr D de Jong, xx, xx, , South Africa Dr D de Jong, Jongaie Research, Medicross Pretoria West, 1st Floor, 551 WF Nkomo Street, Pretoria, 0183, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 02/12/2020 updated website xxx www.firebrickpharma.com
Section Name Field Name Date Reason Old Value Updated Value
Trial Information COMPLETION_STATUS 31/08/2021 Trial Completed In Progress Completed