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-27-032022-7241 Date of Approval: 29/03/2022
Trial Status: Approved
TRIAL DESCRIPTION
Public title FBP-007_Nasodine for Elimination of COVID-19 Shedding study “NASO-ELOCS”
Official scientific title Reduction of nasal shedding of SARS-CoV-2 in COVID-19 positive patients by the use of Nasodine® (povidone-iodine 0.5%) Nasal Spray.
Brief summary describing the background and objectives of the trial The study is a double-blinded, randomised, controlled Phase 2 study. Enrolled subjects will be randomised 2:1 to Nasodine treatment or placebo (Control) by household. The primary aim of the trial will be to show that frequent Nasodine application (every 2 waking hours, up to eight-times-daily) over 3 days leads to a reduction in nasal shedding from culture-positive COVID-19 patients, as measured by the reduction (versus baseline) in log10 of TCID50 titres on Days 2-4 compared with placebo. Secondary objectives will be to determine if the treatment leads to: (a) people clearing the virus from their nasal passages more quickly based on culture; (b) reduction in the time to a negative RAT (rapid antigen test) test; (c) overall elimination of SARS-CoV-2 from the upper respiratory tract within 5 days, based on a combined throat/nasal swab; and (d) a beneficial impact on symptoms.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Covid-19
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 31/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group FBP007 a total dose of 1.12 mL based on 4 sprays per nostril applied every 2 hours for a total of 20 doses over 3 days Nasodine Nasal Spray, containing povidone-iodine 0.5%, plus excipients and buffers, in a nasal spray bottle nominally holding 25 mL and with a nasal spray pump designed to deliver 0.14 mL per actuation, for a total dose of 1.12 mL based on 4 sprays per nostril 100
Control Group FBP007 4 sprays per nostril applied every 2 hours for a total of 20 doses over 3 days The purpose of placebo control is to determine the pure pharmacological effect of the drug and perform reliable assessments by distinguishing AEs caused by drugs from those caused by natural progression of disease or other causes[2]. In addition, using placebo enables randomization and blinding process and minimizes the bias in subject management and data analysis. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age 18 years or older 2. Reside in a household with at least 2 (two) other adults. 3. Return a positive RAT. 1. Exhibit COVID symptoms for more than 3 days. 2. Known iodine sensitivity 3. Known thyroid disease 4. Pregnant or nursing (breast-feeding) 5. Intending to use a povidone-iodine gargle during the study 6. Any condition or consideration deemed by the MO to interfere with assessments or represent a risk to compliance 7. Unwilling to sign the informed consent form (PICF) 8. Any vaccination may lead to COVID-like symptoms for up to 24-48 hours, so any subjects who have received a vaccine in the week prior to enrolment will be excluded from the trial. Similarly anyone scheduled to or intending to be vaccinated (flu or COVID) during the 14-day period of the trial will be excluded. In all cases, trial personnel will encourage participants to get the COVID vaccine if available. Adult: 19 Year(s)-105 Year(s) 18 Year(s) 85 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 21/01/2022 SAHPRA
Ethics Committee Address
Street address City Postal code Country
CSIR Reception Building 38a Meiring Naudé Road Brummeria Pretoria Pretoria 0083 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 23/02/2022 PharmaEthics
Ethics Committee Address
Street address City Postal code Country
123 Amkor Road Lyttelton manor Ext 3 Centurion 0157 Centurion 0157 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome (1) Impact on viral shedding after 20 doses of Nasodine over 3 days (IITi): The use of Nasodine every 2 hours for 20 doses will be assessed by the comparison of the quantity of culturable (infectious) virus before treatment with the amount of culturable virus after initiating the treatment regimen. Mid-turbinate swabs will be collected before the first treatment and again on days 2 and 3 between treatments and again on day 4 when treatment has been concluded. Quantitative culture will be performed via TCID50 assay using Vero cells and a half log10 dilution series in triplicate. Plates will be scored by microscopic inspection and expressed as TCID50/mL. The least square mean (average) of the TCID50/ML for each subject will be calculated and the percent reduction from baseline determined. The average reduction for the Nasodine population will be compared against the placebo population. The result will be expressed as the increase in log reduction in the Nasodine population over the placebo population. Mid-turbinate swabs will be collected before the first treatment and again on days 2 and 3 between treatments and again on day 4 when treatment has been concluded.
Secondary Outcome (1) URT clearance (IITi): Nose and throat swabs will be collected on day 5 and be combined and cultured to determine the presence of culturable (infectious) virus for each subject. The proportion of subjects shedding infectious virus in the Nasodine population will be compared against the proportion of subjects shedding infectious virus in the placebo population. The result will be expressed as the improvement of Nasodine against placebo: Day 5
Secondary Outcome (2) Symptom severity on Day 3 (ITT): Subjects will be asked a series of questions by study staff to ascertain the severity of their symptoms. An outline of the questions is presented in Appendix 1. Subjects will be surveyed on Day 1 prior to commencing treatment and again on Day 3 when the study staff visit the subject’s residence. (we need a protocol of data analysis here) Day 3
Secondary Outcome (3) Symptom severity on Day 4 (ITT): Subjects will be asked a series of questions by study staff to ascertain the severity of their symptoms. An outline of the questions is presented in Appendix 1. Subjects will be surveyed on Day 1 prior to commencing treatment and again on Day 4 when the study staff visit the subject’s residence. (we need a protocol of data analysis here) Day 4
Secondary Outcome (4) Symptom severity on Day 5 (ITT): Subjects will be asked a series of questions by study staff to ascertain the severity of their symptoms. An outline of the questions is presented in Appendix 1. Subjects will be surveyed on Day 1 prior to commencing treatment and again on Day 5 when the study staff visit the subject’s residence. (we need a protocol of data analysis here) Day 5
Secondary Outcome (5) Time to cessation of shedding (ITT): RAT negative: Subjects will undergo a RAT using an anterior nasal swab each day from Day 1 to Day 5. The average duration to cessation of shedding will be calculated for both the Nasodine and placebo populations and the difference in days between the groups reported: Reduction in time to cessation = average Nasodine duration – average placebo duration Day 1 to Day 5
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Langeberg Medical Centre Langeberg Medical Centre Corner Brighton and Kipling Roads Kraaifontein Cape Town 2570 South Africa
Be Part Yoluntu Centre 4 Madikane St, Mbekweni Paarl 7626 South Africa
Paarl Research Centre 9a Verster St, Lemoenkloof Paarl 7646 South Africa
TASK Smith Street, Glenlily Cape Town 7500 South Africa
Tiervlei Trial Centre Karl Bremer Hospital, Mike Pienaar Boulevard, Bellville Cape Town 7531 South Africa
Ndlovu Research Centre Plot 1140, Elandsdoorn Dennilton Limpopo 0470 South Africa
Sandton Medical Research Centre Wellness on Alon, 49 East Road, Morningside Sandton 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Firebrick Pharma Pty ltd Firebrick Pharma Limited L10, 440 Collins St Melbourne VIC 3000 Australia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Firebrick Pharma Pty Ltd Firebrick Pharma Limited L10, 440 Collins St, Melbourne VIC 3000 Melbourne VIC 3000 Australia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
OnQ Research 250 Market Street, Fairland, Randburg Johannesburg 2030 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Julian Trokis trokisjs@medicross.co.za +27219871690 Langeberg Clinical Trials, Cnr Brighton Kipling Roads
City Postal code Country Position/Affiliation
Kraaifontein Cape Town 7570 South Africa National Principal Investigator
Role Name Email Phone Street address
Public Enquiries Bicky Mthombeni bickym@onqsa.co.za +27114310791 250 Market Street, Fairland,
City Postal code Country Position/Affiliation
Randburg 2190 South Africa Project Operations Director
Role Name Email Phone Street address
Scientific Enquiries Stephen Goodall sgoodall@firebrickpharma.com +61417751244 Firebrick PTY Ltd, Level 9, 440 Collins Street
City Postal code Country Position/Affiliation
Melbourne VIC 3000 Australia Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, the private statement is 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
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 Anticipated trial start date 17/03/2022 as per approval start date 15 Jan 2022 01 Mar 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 17/03/2022 as per approval 01 Mar 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 17/03/2022 as per approval 30 Apr 2022 29 Jul 2022
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 17/03/2022 Budget amount inserted Firebrick Pharma Pty ltd, Firebrick Pharma Limited L10, 440 Collins St, Melbourne, VIC 3000, Australia, Commercial Sector / Industry, , 0, Primary Funder Firebrick Pharma Pty ltd, Firebrick Pharma Limited L10, 440 Collins St, Melbourne, VIC 3000, Australia, Commercial Sector / Industry, , R10 000 000, Primary Funder
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 29/03/2022 Upfdate the name site Langeberg Clinical Trials, Langeberg Clinical Trials Langeberg Medical Centre Corner Brighton and Kipling Roads Kraaifontein, Cape Town, 2570, South Africa Langeberg Medical Centre, Langeberg Clinical Trials Langeberg Medical Centre Corner Brighton and Kipling Roads Kraaifontein, Cape Town, 2570, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 29/03/2022 update the site name Langeberg Medical Centre, Langeberg Clinical Trials Langeberg Medical Centre Corner Brighton and Kipling Roads Kraaifontein, Cape Town, 2570, South Africa Langeberg Medical Centre, Langeberg Medical Centre Corner Brighton and Kipling Roads Kraaifontein, Cape Town, 2570, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/04/2022 changed from no recruiting to recruiting Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 26/04/2022 changed from single to double blinded The study is a single-blinded, randomised, controlled Phase 2 study. Enrolled subjects will be randomised 2:1 to Nasodine treatment or placebo (Control) by household. The primary aim of the trial will be to show that frequent Nasodine application (every 2 waking hours, up to eight-times-daily) over 3 days leads to a reduction in nasal shedding from culture-positive COVID-19 patients, as measured by the reduction (versus baseline) in log10 of TCID50 titres on Days 2-4 compared with placebo. Secondary objectives will be to determine if the treatment leads to: (a) people clearing the virus from their nasal passages more quickly based on culture; (b) reduction in the time to a negative RAT (rapid antigen test) test; (c) overall elimination of SARS-CoV-2 from the upper respiratory tract within 5 days, based on a combined throat/nasal swab; and (d) a beneficial impact on symptoms. The study is a double-blinded, randomised, controlled Phase 2 study. Enrolled subjects will be randomised 2:1 to Nasodine treatment or placebo (Control) by household. The primary aim of the trial will be to show that frequent Nasodine application (every 2 waking hours, up to eight-times-daily) over 3 days leads to a reduction in nasal shedding from culture-positive COVID-19 patients, as measured by the reduction (versus baseline) in log10 of TCID50 titres on Days 2-4 compared with placebo. Secondary objectives will be to determine if the treatment leads to: (a) people clearing the virus from their nasal passages more quickly based on culture; (b) reduction in the time to a negative RAT (rapid antigen test) test; (c) overall elimination of SARS-CoV-2 from the upper respiratory tract within 5 days, based on a combined throat/nasal swab; and (d) a beneficial impact on symptoms.
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/11/2022 Additional sites to assist with meeting recruitment targets Ndlovu Research Centre, Plot 1140, Elandsdoorn, Dennilton Limpopo, 0470, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 24/11/2022 Additional sites to assist with meeting recruitment tagets Sandton Medical Research Centre, Wellness on Alon, 49 East Road, Morningside, Sandton, 2196, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 24/11/2022 Easy identification Nasodine for Elimination of COVID-19 Shedding study “NASO-ELOCS” FBP-007_Nasodine for Elimination of COVID-19 Shedding study “NASO-ELOCS”
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 23/01/2023 Recruitment timelines extended due to slow recruitment (anticipated COVID-19 wave did not occur in Oct/Sep 2022). 29 Jul 2022 31 Aug 2023
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 23/01/2023 Resignation of Sello Seahlohli Public Enquiries, Sello, Seahloli, Dr., sellos@onqsa.co.za, , +274310763, 250 Market Street, Fairland, , Randburg, 2190, South Africa, Executive Director Public Enquiries, Bicky, Mthombeni, Ms., bickym@onqsa.co.za, , +27114310791, 250 Market Street, Fairland, , Randburg, 2190, South Africa, Project Operations Director