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Trial registered on ANZCTR


Registration number
ACTRN12621000604808
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
20/05/2021
Date last updated
3/04/2024
Date data sharing statement initially provided
20/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Confirmatory Phase III study of Nasodine Nasal Spray (povidone-iodine 0.5%) as a symptomatic treatment for early stage common cold in the natural setting.
Scientific title
Confirmatory Phase III study of Nasodine Nasal Spray (povidone-iodine 0.5%) as a symptomatic treatment for early stage common cold in the natural setting.
Secondary ID [1] 303900 0
FBP-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Common Cold 321485 0
Condition category
Condition code
Infection 319239 319239 0 0
Other infectious diseases
Respiratory 319544 319544 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasodine Nasal Spray, an aqueous solution of 0.5% povidone-iodine (PVP-I) administered intra-nasally with 3 sprays of 140µL per spray per nostril (for a total dose of approximately 0.84mL), 4 times per day (approximately 4 hours apart during waking hours) for 5 consecutive days.
Prior to administration of the first dose, participants will be trained by clinic staff to administer the dose correctly, as well as in the use of the electronic diary.
The first dose will be self-administered by the participant under the supervision of clinic staff; all subsequent doses will be self-administered and recorded in the electronic diary by the participant.
Participants will be contacted to arrange collection/ drop-off of IP bottle after completion of dosing for accountability purposes.
Intervention code [1] 320207 0
Treatment: Drugs
Comparator / control treatment
Matching placebo nasal spray – water coloured with topical use dye to mimic colour of Nasodine.
Control group
Placebo

Outcomes
Primary outcome [1] 327109 0
To demonstrate overall cold severity, based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Global Severity Score (GSS) in all participants confirmed to have presence of a respiratory virus (other than SARS-CoV-2) treated with Nasodine compared with Placebo which is calculated as the sum of scores of the 19 symptoms and QoL (item 2-20) in the WURSS-21 survey, over the 5-day treatment period (Days 2-6).
Timepoint [1] 327109 0
Participants will complete the WURSS-21 questionnaire once daily on Days 1-6. The GSS will be calculated as the sum of the daily scores over 5 days (Days 2-6).
A baseline WURSS-21 score will be determined from the completion of the WURSS-21 questionnaire on Day 1, under the supervision of clinic staff. Completion of the WURSS on Days 2-6 will be at approximately the same time of day as on Day 1.
Secondary outcome [1] 393827 0
[Key Secondary Outcome] To determine Global Severity Score (GSS) for Nasodine versus placebo in all enrolled participants including those without confirmed viral infection and those PCR positive for SARS-CoV-2. The GSS is calculated as the sum of scores of the 19 symptom and QoL items (Items 2-20) in the WURSS-21 survey , over the 5-day treatment period (Days 2-6). Participants will complete the WURSS-21 questionnaire vial the electronic webapp diary.
Timepoint [1] 393827 0
The GSS will be calculated as the sum of the daily scores over 5 days (Days 2-6). A baseline WURSS-21 score will be determined from the completion of the WURSS-21 questionnaire on Day 1, under the supervision of clinic staff. Completion of the WURSS on Days 2-6 will be at approximately the same time of day as on Day 1.
Secondary outcome [2] 393828 0
To determine Global Severity Score (GSS) for Nasodine versus placebo in all enrolled participants who started treatment within 24 hours of symptoms onset; The GSS is calculated as the sum of scores of the 19 symptom and QoL items (Items 2-20) in the WURSS-21 survey , over the 5-day treatment period (Days 2-6). Participants will complete the WURSS-21 questionnaire vial the electronic webapp diary.
Timepoint [2] 393828 0
Participants will complete the WURSS-21 questionnaire once daily on Days 2-6. The GSS will be calculated as the sum of the daily scores over the 5 days.
A baseline WURSS-21 score will be determined from the completion of the WURSS-21 questionnaire on Day 1, under the supervision of clinic staff.
Completion of the WURSS on Days 2-6 will be at approximately the same time of day as on Day 1.
Secondary outcome [3] 393829 0
To determine QoL for Nasodine versus placebo in participants confirmed to have presence of a respiratory virus (other than SARS-CoV-2); assessed as the sum of scores over 5 days (Days 2-6) for the Quality of Life (QoL) items (12-20) of the WURSS-21 survey. Participants will complete the WURSS-21 questionnaire via the electronic webapp diary.
Timepoint [3] 393829 0
Participants will complete the WURSS-21 questionnaire once daily on Days 2-6. The WURSS score will be calculated as the sum of the daily QoL scores over the 5 days. A baseline WURSS-21 score will be determined from the completion of the WURSS-21 questionnaire on Day 1, under the supervision of clinic staff. Completion of the WURSS on Days 2-6 will be at approximately the same time of day as on Day 1.
Secondary outcome [4] 393830 0
To determine Quality of Life (QoL) for Nasodine versus placebo in the whole population of enrolled participants including those without confirmed viral infection and those PCR positive for SARS-CoV-2; assessed as sum of scores of the 19 symptom and QoL items (items 2-20) in the WURSS-21 survey, over 5-day treatment period (Days 2-6).
Timepoint [4] 393830 0
Participants will complete the WURSS-21 questionnaire once daily on Days 2-6. The WURSS score will be calculated as the sum of the daily QoL scores over the 5 days.
A baseline WURSS-21 score will be determined from the completion of the WURSS-21 questionnaire on Day 1, under the supervision of clinic staff. Completion of the WURSS on Days 2-6 will be at approximately the same time of day as on Day 1.
Secondary outcome [5] 393831 0
To determine Quality of Life (QoL) for Nasodine versus Placebo in all enrolled participants who started treatment within 24 hours of symptom onset; assessed as the sum of scores over 5 days (Days 2-6) for QoL items (12-20) of the WURSS-21 survey. Participants will complete the WURSS-21 questionnaire vial the electronic webapp diary.
Timepoint [5] 393831 0
Participants will complete the WURSS-21 questionnaire once daily on Days 2-6. The WURSS score will be calculated as the sum of the daily QoL scores over the 5 days. A baseline WURSS-21 score will be determined from the completion of the WURSS-21 questionnaire on Day 1, under the supervision of clinic staff. Completion of the WURSS on Days 2-6 will be at approximately the same time of day as on Day 1.
Secondary outcome [6] 393832 0
To determine Time to Alleviation of Illness (TAI) versus placebo in participants confirmed to have presence of a respiratory virus (other than SARS-CoV-2), measured from Day 1 (enrolment) to Day 14 (end of study), as the mean number of days to no item on the QoL scale being rated greater than mild. Assessed by QoL items (12-20) in the WURSS-21 survey questionnaires via the electronic diary.
Timepoint [6] 393832 0
Participants will record any adverse events that occur from Day 1 until Day 14. Adverse events will be recorded at the same time as completion of WURSS on Days 1-6, and approximately the same time each day on Days 7-14.
Secondary outcome [7] 433545 0
To determine Time to Alleviation of Illness (TAI) in whole population of enrolled participants treated with Nasodine compared with placebo. Participants will complete the WURSS-21 questionnaire via the electronic webapp diary.
Timepoint [7] 433545 0
Participants will record any adverse events that occur from Day 1 until Day 14. Adverse events will be recorded at the same time as completion of WURSS on Days 1-6, and approximately the same time each day on Days 7-14.
Secondary outcome [8] 433546 0
To determine Time to Alleviation of Illness (TAI) in whole population of enrolled participants treated with Nasodine compared with placebo who started treatment within 24 hours of symptom onset. Participants will complete the WURSS-21 questionnaire via the electronic webapp diary.
Timepoint [8] 433546 0
Participants will record any adverse events that occur from Day 1 until Day 14. Adverse events will be recorded at the same time as completion of WURSS on Days 1-6, and approximately the same time each day on Days 7-14.

Eligibility
Key inclusion criteria
- Access to a smartphone or tablet to run the webapp (for electronic diary)
- Subject must respond affirmatively to the question: “Do you think you have a cold?”
- Subject must have a runny nose and must report at least two of the other 7 Jackson symptoms – sneezing, sore throat, nasal congestion, cough, feeling unwell, chills, headache – plus a ‘moderate’ or ‘severe’ (i.e., not ‘mild’) score on at least one of the Jackson symptoms (including runny nose, but excluding sneezing) with a total Jackson score of at least 6.
- Cold symptoms started less than 36 hours prior to enrolment with a known time and date of symptom onset, which must be recorded
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Positive result on a SARS-CoV-2 Rapid Antigen Test
- Fever >38°C; actual temperature will be recorded during screening
- Known iodine sensitivity
- Known thyroid disease
- Pregnant or nursing (breast-feeding)
- Intending to use during the study, any other nasal spray or any OTC cold medication that could influence study results (antihistamines, decongestants, combination cough/cold medications); paracetamol will be available as a rescue medication for any disabling symptoms; concomitant medications will be recorded
- Intending to use a povidone-iodine gargle during the study
- Any condition or consideration deemed by the Medical Officer (MO) to interfere with assessments or represent a risk to compliance; this will be assessed by a limited PE (physical exam) and nasal exam during screening
- Unwilling to sign the informed consent form (PICF)
- Anyone deemed to be a high-risk COVID-19 including the elderly, those with chronic diseases such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer, and anyone who is unvaccinated for COVID-19.
- Any vaccination may lead to cold/flu-like symptoms, 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 or continue with COVID vaccine boosters after the trial is completed.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is the off-site pharmacist with no contact with participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is up to 500 in total with an Intention to Treat shown to be virally-infected (ITTi) sample size of at least 196 for this study with subjects randomised 1:1 for Nasodine versus placebo.
The sample size for this study is derived from updated power calculations using published data and the data obtained in the Phase III study FBP-002. Using this sample size, the study will have 80% power to detect a difference a 20% reduction for Nasodine versus placebo on the primary endpoint, using a t-test with a 5% 2-sided level of significance. During the study, the number of subjects discontinuing prematurely will be monitored (blinded) and if required additional subjects may be recruited. A full statistical analysis plan will be prepared prior to completion of the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2022
Actual
3/05/2022
Date of last participant enrolment
Anticipated
30/08/2023
Actual
8/08/2023
Date of last data collection
Anticipated
30/09/2023
Actual
22/08/2023
Sample size
Target
500
Accrual to date
Final
502
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 19069 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [2] 21956 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 33619 0
5000 - Adelaide
Recruitment postcode(s) [2] 37049 0
3220 - Geelong
Recruitment outside Australia
Country [1] 24655 0
South Africa
State/province [1] 24655 0
Langeberg Clinical Trials, Cape Town
Country [2] 25423 0
South Africa
State/province [2] 25423 0
Sandton Medical Research Centre (SMRC), Sandton Gauteng 2196
Country [3] 25424 0
South Africa
State/province [3] 25424 0
Paarl Research Centre, Paarl 7646 South Africa

Funding & Sponsors
Funding source category [1] 308289 0
Commercial sector/Industry
Name [1] 308289 0
Firebrick Pharma Limited
Country [1] 308289 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Firebrick Pharma Limited
Address
L10, 440 Collins St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 309094 0
None
Name [1] 309094 0
Address [1] 309094 0
Country [1] 309094 0
Other collaborator category [1] 281713 0
Commercial sector/Industry
Name [1] 281713 0
Avance Clinical
Address [1] 281713 0
213 Glynburn Rd, Firle SA 5070, Australia
Country [1] 281713 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308264 0
Bellberry Limited
Ethics committee address [1] 308264 0
Ethics committee country [1] 308264 0
Australia
Date submitted for ethics approval [1] 308264 0
08/04/2021
Approval date [1] 308264 0
01/06/2021
Ethics approval number [1] 308264 0
Ethics committee name [2] 310544 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [2] 310544 0
Ethics committee country [2] 310544 0
Australia
Date submitted for ethics approval [2] 310544 0
01/03/2022
Approval date [2] 310544 0
Ethics approval number [2] 310544 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110126 0
Dr Thomas Polasek
Address 110126 0
CMAX Clinical Research,
Level 5, 18a North Terrace Adelaide SA 5000
Country 110126 0
Australia
Phone 110126 0
+61 8 7088 7900
Fax 110126 0
Email 110126 0
thomas.polasek@cmax.com.au
Contact person for public queries
Name 110127 0
Thomas Polasek
Address 110127 0
CMAX Clinical Research,
Level 5, 18a North Terrace Adelaide SA 5000
Country 110127 0
Australia
Phone 110127 0
+61 8 7088 7900
Fax 110127 0
Email 110127 0
thomas.polasek@cmax.com.au
Contact person for scientific queries
Name 110128 0
Thomas Polasek
Address 110128 0
CMAX Clinical Research,
Level 5, 18a North Terrace Adelaide SA 5000
Country 110128 0
Australia
Phone 110128 0
+61 8 7088 7900
Fax 110128 0
Email 110128 0
thomas.polasek@cmax.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is being conducted to complete a confidential regulatory dossier and is not intended for general publication.


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
EmbaseSARS-CoV-2 co-infections during an ongoing phase III common cold trial.2023https://dx.doi.org/10.1111/imj.16165
Dimensions AIIn vitro Nasodine Can be an Effective Antibiofilm Agent for Biofilms that May Cause CRS2023https://doi.org/10.1002/lary.30558
N.B. These documents automatically identified may not have been verified by the study sponsor.