Low pH Hypromellose (Taffix™) nasal powder spray reduced SARS-CoV-2 infection rate post mass-gathering event at a highly endemic community: An observational prospective open label user survey

Abstract

The city of Bney Brak, Israel, (population 210,000 mostly ultra-orthodox Jews) tops Israel list of COVID-19 infection rate and mortality. In mid-September before the Jewish New Year (an intensive two day gathering for prayers ) PCR positivity rates were 17.6% and those climbed to 28.1% two weeks later.Taffix - is an innovative nasal powder inhaler that creates a protective gel layer over the nasal mucosa and effectively blocks viruses from infecting the nasal cells. Taffix is approved for use in Europe and Israel. In vitro studies demonstrated that Taffix blocks viruses (including SARS- CoV-2) from infecting human cells (<99% ). It is well established that the nose is the main gateway of SARS- CoV-2 to the body. Taffix™ was developed as an additional virus protective tool beyond the currently recommended preventive measures.In a prospective users survey, 243 members of a Jewish ultra-orthodox synagogue community in Bney Brak that participated in the two days holidays prayers (7 hours spent daily in the synagogue) were followed up for the following 14 days to measure the effect of Taffix in this potentially “super spread” ( post mass gathering) event . 83 collected and used Taffix throughout Rosh Hashana prayers and for the following two weeks (intention to treat group, ITT) . 81 of them used it regularly as instructed ( per protocol, PP) while two used it rarely if at all. The remaining 160 did not use Taffix .At the end of the two weeks follow up - in the ITT population, 2/83 (2.4%) of the Taffix users and 16/160 (10%) of the Taffix non users were infected. The odds ratio for SARS-CoV-2 infection in Taffix users were 0.22 (0.05-0.99, Mid P exact =0.028), a reduction of 78% (95%CI 1%-95%) in odds of infection. No side effects were reported.We suggest that Taffix can be an additional powerful tool against COVID19 spread. To our knowledge this is the first time that any measure to prevent infection in SARS-CoV-2 virus, beyond the use of masks. was proven effective.