COVID-19, Upper Respiratory Tract Infections
Conditions
Keywords
Upper respiratory tract infection, viruses, COVID-19, nasal, powder, prevention, SARS-CoV-2
Brief summary
TAFFIX is a nasal powder spray that immediately creates a protective acidic barrier on the nasal mucosa against infection by inhaled viruses. The protective barrier lasts 5 hours. TAFFIX is approved as a medical device in Israel, intended for use to block inhaled viruses within the nasal cavity. In Europe, it is registered as a medical device indicated for use as a protective mechanical barrier against allergens and viruses (e.g., SARS-CoV-2) within the nasal cavity. TAFFIX is used as additional safety mean together with masks, hygiene, and social distancing. The study rationale is to evaluate whether daily use of TaffiX™ as prophylaxis will reduce the rate of SARS- CoV-2 infection and other upper respiratory infections, compared to the placebo control rate.
Detailed description
Study Design: This is a 2 arms, Randomized, double blind, placebo controlled clinical trial. Study population: Subjects who, were not diagnosed with COVID-19 previously to their best knowledge and according to COVID-19 antibody test. Were not vaccinated yet against COVID-19 and will not be vaccinated during their participating in the study. Up to 1000(500 per study arm) will be enrolled for the purpose of this study. Study treatment: TaffiX™ will be used daily (up to 3 times a day, every 5 hours) in addition to the protective measures instructed by the Ministry of Health The control group will be administrated with Placebo- lactose powder for nasal application Participation duration: Up to 6 weeks Concomitant therpay: Allowed- no restriction for Concomitant Medications Planned interim analyses: When no less than 150 subjects have completed the study, an interim analysis for Efficacy and safety will be conducted by an independent biostatistician. After no less than 500 subjects, additional interim analysis for Efficacy and safety will be conducted by an independent biostatistician. Serious adverse events will be monitored by an independent safety officer on an ongoing basis throughout the study. Stop Rule: If the proportion of COVID-19 positive rate in the treatment group is statistically significantly lower than the proportion of COVID-19 positive rate in the placebo control group.
Interventions
DEVICETaffiX™
Personal nasal powder spray.
Sponsors
Nasus Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Double blind.
Eligibility
Sex/Gender
ALL
Age
12 Years to 120 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects 12 yr and older who had not previously been infected with COVID-19 to the best of their knowledge. 2. Were not vaccinated yet against COVID-19 and will not be vaccinated during the study (if they decide to get the vaccine during the study they will be excluded a week later). 3. Negative serology rapid test to COVID-19. 4. Be informed of the nature of the study and the procedures and sign an informed consent form. 5. Willing and able to adhere to Protocol requirements. 6. If female of childbearing potential, agree to use an acceptable method of birth control or be surgically sterile, and have a negative pregnancy test.
Exclusion criteria
1. Known sensitivity to citric acid and/or sodium citrate and /or benzalkonium chloride and /or Hydroxypropylmethylcellulose (HPMC) or lactose (does not mean diagnosed lactose intolerance in food). 2. Females who are pregnant or are lactating as reported by the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 new cases | Through study completion, 6 weeks | symptoms score (Fever; Cough; Rigors; Myalgia; Headache; Vomiting or Diarrhea; Shortness of breath; Breathing difficulties; New olfactory and taste disorder(s); Runny or stuffy nose; Sore throat) as reported in Bi-weekly questionnaires, PCR or antigen test at symptomatic subjects, serology test at end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety and tolerability of the study device. | Through study completion, 6 weeks. | Incidence of adverse events as reported by subjects |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of Taffix in preventing upper respiratory infection | Through study completion, 6 weeks | Incidence of symptoms (Fever; Cough; Rigors; Myalgia; Headache; Vomiting or Diarrhea; Shortness of breath; Breathing difficulties; New olfactory and taste disorder(s); Runny or stuffy nose; Sore throat), as reported in Bi-weekly questionnaires, at subjects who were negative to SARS-CoV-2 |
| Severity of COVID-19 | Through study completion, 6 weeks | Severity of COVID-19 cases (according to NIH severity categories) |
| Change in Allergic Rhinitis or Asthma symptoms in relevant subjects | Through study completion, 6 weeks | By report to the study coordinator, among subjects who reported of that condition at the entry to the study. |
Countries
Bulgaria
Outcome results
None listed