An interventional study of TaffiX™ in COVID-19 and Upper Respiratory Tract Infections, sponsored by Nasus Pharma. Completed at 1 site in Bulgaria. Open to participants aged 12 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by Nasus Pharma · Not applicable, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 693 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Nasus Pharma is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TaffiX™ is a Nasal powder personal spray that blocks viruses particles from entering the nasal cells.
Device: TaffiX™
Lactose nasal powder will be used as a placebo. It has an identical appearance as TaffiX™ (white powder in an identical bottle).
Device: TaffiX™
Personal nasal powder spray.
COVID-19 new cases
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.
Time frame: Through study completion, 6 weeks
The safety and tolerability of the study device.
Incidence of adverse events as reported by subjects
Time frame: Through study completion, 6 weeks.
To evaluate the efficacy of Taffix in preventing upper respiratory infection
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
Time frame: Through study completion, 6 weeks
Severity of COVID-19
Severity of COVID-19 cases (according to NIH severity categories)
Time frame: Through study completion, 6 weeks
Change in Allergic Rhinitis or Asthma symptoms in relevant subjects
By report to the study coordinator, among subjects who reported of that condition at the entry to the study.
Time frame: Through study completion, 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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