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.
- Conditions
- Common ColdInfection - Other infectious diseasesRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12621000604808
- Lead Sponsor
- Firebrick Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 502
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
- 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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). [ 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). <br>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 Measures
Name Time Method