Low pH Hypromellose (Taffix) nasal powder spray could reduce SARS-CoV-2 infection rate post mass-gathering event at a highly endemic community: an observational prospective open label user survey
et al., Expert Review of Anti-infective Therapy, doi:10.1080/14787210.2021.1908127, Apr 2021
Prospective observational study of 243 community members showing significantly lower SARS-CoV-2 infection with Taffix nasal spray during a high-risk mass gathering event. During the 14-day follow-up, 0% of per-protocol Taffix users (0/81) became infected compared to 10% of non-users (16/160). Among intention-to-treat users, 2.4% (2/83) became infected versus 10% in non-users. The study occurred during peak COVID-19 transmission in Bney Brak, Israel, where infection rates increased from 17.6% to 28.1% during the study period. Users may have been more health-conscious and careful with other protective measures. No adverse events were reported.
Targeted administration to the respiratory tract provides treatment directly
to the typical source of initial SARS-CoV-2 infection and replication, and
allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
|
risk of case, 75.9% lower, RR 0.24, p = 0.04, treatment 2 of 83 (2.4%), control 16 of 160 (10.0%), NNT 13.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Shmuel et al., 30 Apr 2021, prospective, Israel, peer-reviewed, 4 authors, study period 18 September, 2020 - 2 October, 2020.
Contact: dalia@nasusphama.com.
Low pH Hypromellose (Taffix) nasal powder spray could reduce SARS-CoV-2 infection rate post mass-gathering event at a highly endemic community: an observational prospective open label user survey
Expert Review of Anti-infective Therapy, doi:10.1080/14787210.2021.1908127
Objectives: Bney Brak city tops Israel's COVID-19 infection rate and mortality. Before the Jewish New Year (two-day gathering) SARS-CoV-2 PCR positivity rates were 17.6% and reached 28.1% two weeks later Taffix -an innovative nasal powder creates a protective gel over the nasal mucosa blocking viruses from infecting nasal cells, was tested for efficacy in preventing SARS CoV2 infection. Methods: In a prospective users survey, 243 members of an ultra-orthodox community that participated in two days prayers were followed for 14 days following this 'superspread' event. Eighty-three used Taffix throughout holiday's prayers and the following two weeks (ITT). Eighty-one used it regularly (PP). Two used it rarely if at all. The remaining 160 did not use Taffix. Results: After 14 days, 0/81 (0%) of (PP) Tafffix users, 2/83 (2.4%) of (ITT) Taffix users and 16/160 (10%) nonusers were infected. Odds ratio for infection among Taffix users was 0.22, a reduction of 78% (95%CI 1%-95%). No side effects reported. Conclusion: Taffix could be an additional tool against COVID19 spread, in addition to recommended safety measures. This is the first time that a prevention measure of SARS-CoV-2, beyond the use of masks, has proved effective.
Declaration of interest D Megiddo is the CEO of Nasus Pharma, the manufacturer of Taffix. T Lapidot is the VP clinical of Nasus Pharma, the manufacturer of Taffix. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures Peer reviewers on this manuscript have received an honorarium for their review work, Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.
Author contributions SK and YN developed the study protocol and participated in the analysis of the results and the written manuscript DM and TL developed the study protocol and participated in the analysis of the results and the written manuscript as well as in the follow up and operation of the study
References
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