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Short Report
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- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
Introduction: 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.
Methods: 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 .
Results: 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.
Conclusion: 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.
Keywords
SARS-CoV-2, COVID 19, Prevention, Hypromellose, Nasal spray, H1N1, low pH, respiratory viral infection
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Short Report
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
View the published article at Expert Review of Anti-infective Therapy.
Community comments: 10
Version 2
Posted 20 Jan, 2021
Community comments: 8
Community comments: 17
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Declarations:
Declarations
- This study involved human subjects.
- The author confirmed that all appropriate ethical guidelines for the use of human subjects have been followed, any necessary IRB and/or ethics committee review has been obtained, and information about the IRB/ethics committee is included in the manuscript.
- The author has confirmed that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived. If the IRB/ethics committee waived the requirement for patient/participant consent or assent, an explanation for the waiver is included in the text.
- This study reports on a clinical trial.
- The author has confirmed that this trial has been registered with an ICMJE-approved registry, and the trial registration ID has been provided in the text. If the article reports on a study that was registered retrospectively, a statement explaining why the study was not registered in advance has been provided in the text.
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
View the published article at Expert Review of Anti-infective Therapy.
Introduction: 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.
Methods: 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 .
Results: 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.
Conclusion: 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.
Figure 1
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