COVID-19 Clinical Trial
Official title:
COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
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. ;
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