None listed
Conditions
Brief summary
This research project is being conducted to determine whether treatment with Nasodine Nasal Spray reduces the severity of the common cold when given within 36 hours of symptom onset and over 5 consecutive days, multiple times a day.
Interventions
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 p
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.
Sponsors
Firebrick Pharma Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed