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Short Report
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
Megiddo Dalia
Nasus Pharma
Corresponding Author
ORCiD: https://orcid.org/0000-0003-4305-9048
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that all necessary patient/participant consent or assent has been obtained and the appropriate institutional forms have been archived.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.
The most recent version of this article is available here.
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.
Keywords
SARS-CoV-2, COVID 19, Prevention, Hypromellose, Nasal spray, H1N1, low pH, respiratory viral infection
Figure 1
Linda Gamlin
commented on 01 January, 2021
Given that the group using the nasal spray was self-selected, it would be important to establish that they were not also taking other protective measures, such as mask wearing, more seriously than the control group. The paper mentions 'mandatory mask wearing' in passing, but does not elaborate. How well did the study population adhere to mask-wearing rules? Was this adherence uniform? This should have been part of the discussion in this paper.
View 1 reply
dominic kelly
commented on 02 January, 2021
This product has been tested on the covid-2 strain yet is now being touted as a blocker for cov 19. The sales website show some of the science but headlines and citations do not Match up. Their link to this paper is just an image of you click on the read the paper. Very sketchy practice if you ask me
View 1 reply
Dalia Megiddo
replied on 02 January, 2021
I am afraid you misread our finding: Taffix was tested with SARS- CoV-2 ( covid-19) virus at the University of Virginia. The results are posted on our website as well as discussed in the paper. I suggest you will refer to the paper and website before making such an unjustified comment.
View 1 reply
Florian Battke
ORCiDreplied on 03 January, 2021
The date from the University of Virgina is referenced as "Unpublished data, In vitro studies performed by Prof. Barbara Man at the University of Virginia in collaboration with Nasus Pharma." Perhaps this data could be made public as well given the strong public interest?
Florian Battke
ORCiDcommented on 03 January, 2021
You cite [5] as a reference that Taffix "prevents viruses from engaging with the receptors that are necessary for the viral penetration into the cells". However, the referenced article by Popov et al [full text here: https://www.dovepress.com/in-vitro-and-in-vivo-evaluation-of-the-efficacy-and-safety-of-powder-h-peer-reviewed-fulltext-article-MDER] does not mention viruses at all, nor does it mention receptor binding. In fact, this paper describes an "experimental setup to demonstrate the inhibition of the diffusion of allergen extracts (house dust mite, Japanese cedar, Ragweed, Timothy grass) and pollutants (particulate matter 2.5 μm, PM2.5)." and finds that low pH hypromellose "...acted as an effective barrier to diffusion of both the liquid allergen extracts and of PM2.5 into the agar covered slides.". If this is a mistake in citation, please provide the correct reference for the stated claim. I could not find any publication online that would substantiate your claim of the product generally inhibiting viral interaction with receptors, nor of anything specific regarding the ACE2 receptor or SARS-CoV-2 spike protein. Not even on the product marketing website which would surely mention such an important finding. Nor by the way could I find any hint that Taffix was considered by any medical authority as a useful tool against the spread of SARS-CoV-2, which is seriously baffling given that the whole world is looking urgently for measures to stop the pandemic and this preprint was published almost two months ago (with initial press releases dating back as far as July 2020)! The fact, mentioned in the press release, that Taffix has been "approved for marketing" the EU might be seen as is slightly misleading, insofar as this refers to a CE marking and not an approval by EMA or other medical body as regulated drug or medical device. As we are all looking for ways out of the pandemic, any further information the authors could provide would be seriously welcome!
View 1 reply
Dalia Megiddo
replied on 04 January, 2021
. 1. Ref 5 : Thank you for pointing out this : The ref 5 should have been placed differently in the sentence namely: “Upon reaching the nasal mucosa HPMC is known to absorb fluids and create a micron-sized gel that covers the nasal cells (5) and prevents viruses from engaging with the receptors that are necessary for the viral penetration into the cells .” The reference to Popov’s article is meant to point out the physical- chemical properties of HPMC. Thank you for pointing this out. This will be corrected in our next version once we receive comments from additional reviewers. 2. One point that should perhaps be made more clearly is that Taffix is not a specific protection against a specific virus/receptor but a non specific physical and chemical blocker of viruses over the nasal cavity. The concept of non specific viral protection in the nose was thoroughly researched and proven by others ( Hull D, Rennie P,- ref 6, James E. Gern: Inhibition of Rhinovirus Replication In Vitro and In Vivo by Acid-Buffered Saline, JID 2007:195 (15 April) and Rennie, P., Bowtell, P., Hull, D. et al. Low pH gel intranasal sprays inactivate influenza viruses in vitro and protect ferrets against influenza infection. Respir Res 8, 38 (2007). https://doi.org/10.1186/1465-9921-8-38 ). We do not claim any specific interaction with the ACE receptor or the S- protein but rather a nonspecific blockage that prevents viruses from reaching cell surface. This last claim is supported by studies we performed in several viruses including the SARS- CoV-2 virus cited in the article and posted on the company’s website. 3. Taffix is classified as medical device class 1 and as such is subject to marketing authorization process. That marketing authorization in Europe is posted on our website and referred to in the article including the approved indication “ Taffix ™ is legally marketed in Europe (CE- DE/CA09/0760/N18/001) with the following Indication for Use: TaffiX ™is indicated for use as a protective mechanical barrier against allergens and viruses (e.g., SARS-CoV-2) within the nasal cavity.” We will happy to provide you with our full whitepaper that summarizes the scientific background and additional information on our pre clinical and clinical work. Please feel free to contact me via email and I will send you the package. Again thank you for your comment and interest.
commented on 06 January, 2021
Is it not possible to purchase just one bottle? The price point is prohibitively high.
View 1 reply
Dalia Megiddo
replied on 07 January, 2021
I will forward your comment to our commercial people for reply. Thank you for your interest
Linda Gamlin
commented on 10 January, 2021
I note that the instructions that come with Taffix say "Do not refrigerate or freeze". If the product is inadvertently exposed to very low temperatures through being left in a vehicle during winter in the northern hemisphere (as has happened with one of my patients), will this inactivate the product or render it less effective?
View 1 reply
Dalia Megiddo
replied on 10 January, 2021
The only effect of cold or humid temperature would be on the flowability of the powder- namely it could be agglomerate and will not fly freely from the bottle. If this is the case- please instruct your patient to approach our customer service and we will be happy to replace his bottle.
Linda Gamlin
commented on 10 January, 2021
I note that the instructions that come with Taffix say "Do not refrigerate or freeze". If the product is inadvertently exposed to very low temperatures through being left in a vehicle during winter in the northern hemisphere (as has happened with one of my patients), will this inactivate the product or render it less effective?
Miranda
commented on 15 January, 2021
Could I ask how many people in the study had previously contracted covid-19?
View 1 reply
Dalia Megiddo
replied on 15 January, 2021
We do not have the numbers for this specific study population however in the city of Bney Brak there were 17% positivity rate at the eve of the study and 28% at the end of the two weeks follow up period.
Raphaela
commented on 16 January, 2021
I would like to purchase just one bottle. It is just for me. Is there any chance you will start selling just one bottle? Thanks!
View 1 reply
Dalia Megiddo
replied on 17 January, 2021
Please send this question through the company's info mailbox on the website
Mr Colm Tumbleton
commented on 20 January, 2021
Just ordered some Taffix. Does the Hydroxypropyl methylcellulose in any way interfere with breathing with, say, sinusitis? I think I read somewhere that the sealing effect prevents allergies and so presumably might ease breathing as also would the menthol.
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CURRENT STATUS: Posted
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Version 1
Posted 02 Nov, 2020
Community comments: 18
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Subject Areas
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Learn more about our company.
This is a preprint. It has not completed peer review.
Short Report
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
Megiddo Dalia
Nasus Pharma
Corresponding Author
ORCiD: https://orcid.org/0000-0003-4305-9048
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Community comments: 1
Version 1
Posted 02 Nov, 2020
Community comments: 18
Metrics
Comments: 18
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.
The most recent version of this article is available here.
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.
Figure 1
Linda Gamlin
commented on 01 January, 2021
Given that the group using the nasal spray was self-selected, it would be important to establish that they were not also taking other protective measures, such as mask wearing, more seriously than the control group. The paper mentions 'mandatory mask wearing' in passing, but does not elaborate. How well did the study population adhere to mask-wearing rules? Was this adherence uniform? This should have been part of the discussion in this paper.
View 1 reply
Dalia Megiddo
replied on 02 January, 2021
Your comment regarding the selection bias of the people who chose to use Taffix is correct. This potential selection bias is discussed in our paper as well. As for the total community: The prayer place was divided into capsule with plastic dividers and people were assign to one capsule and were not allowed to mingle. Mask wearing was mandatory for all and was enforced equally across the whole participants.
View 1 reply
Linda Gamlin
replied on 02 January, 2021
Thanks. May I suggest that it would be useful to add those details to the published paper.
dominic kelly
commented on 02 January, 2021
This product has been tested on the covid-2 strain yet is now being touted as a blocker for cov 19. The sales website show some of the science but headlines and citations do not Match up. Their link to this paper is just an image of you click on the read the paper. Very sketchy practice if you ask me
View 1 reply
Dalia Megiddo
replied on 02 January, 2021
I am afraid you misread our finding: Taffix was tested with SARS- CoV-2 ( covid-19) virus at the University of Virginia. The results are posted on our website as well as discussed in the paper. I suggest you will refer to the paper and website before making such an unjustified comment.
View 1 reply
Florian Battke
ORCiDreplied on 03 January, 2021
The date from the University of Virgina is referenced as "Unpublished data, In vitro studies performed by Prof. Barbara Man at the University of Virginia in collaboration with Nasus Pharma." Perhaps this data could be made public as well given the strong public interest?
Florian Battke
ORCiDcommented on 03 January, 2021
You cite [5] as a reference that Taffix "prevents viruses from engaging with the receptors that are necessary for the viral penetration into the cells". However, the referenced article by Popov et al [full text here: https://www.dovepress.com/in-vitro-and-in-vivo-evaluation-of-the-efficacy-and-safety-of-powder-h-peer-reviewed-fulltext-article-MDER] does not mention viruses at all, nor does it mention receptor binding. In fact, this paper describes an "experimental setup to demonstrate the inhibition of the diffusion of allergen extracts (house dust mite, Japanese cedar, Ragweed, Timothy grass) and pollutants (particulate matter 2.5 μm, PM2.5)." and finds that low pH hypromellose "...acted as an effective barrier to diffusion of both the liquid allergen extracts and of PM2.5 into the agar covered slides.". If this is a mistake in citation, please provide the correct reference for the stated claim. I could not find any publication online that would substantiate your claim of the product generally inhibiting viral interaction with receptors, nor of anything specific regarding the ACE2 receptor or SARS-CoV-2 spike protein. Not even on the product marketing website which would surely mention such an important finding. Nor by the way could I find any hint that Taffix was considered by any medical authority as a useful tool against the spread of SARS-CoV-2, which is seriously baffling given that the whole world is looking urgently for measures to stop the pandemic and this preprint was published almost two months ago (with initial press releases dating back as far as July 2020)! The fact, mentioned in the press release, that Taffix has been "approved for marketing" the EU might be seen as is slightly misleading, insofar as this refers to a CE marking and not an approval by EMA or other medical body as regulated drug or medical device. As we are all looking for ways out of the pandemic, any further information the authors could provide would be seriously welcome!
View 1 reply
Dalia Megiddo
replied on 04 January, 2021
. 1. Ref 5 : Thank you for pointing out this : The ref 5 should have been placed differently in the sentence namely: “Upon reaching the nasal mucosa HPMC is known to absorb fluids and create a micron-sized gel that covers the nasal cells (5) and prevents viruses from engaging with the receptors that are necessary for the viral penetration into the cells .” The reference to Popov’s article is meant to point out the physical- chemical properties of HPMC. Thank you for pointing this out. This will be corrected in our next version once we receive comments from additional reviewers. 2. One point that should perhaps be made more clearly is that Taffix is not a specific protection against a specific virus/receptor but a non specific physical and chemical blocker of viruses over the nasal cavity. The concept of non specific viral protection in the nose was thoroughly researched and proven by others ( Hull D, Rennie P,- ref 6, James E. Gern: Inhibition of Rhinovirus Replication In Vitro and In Vivo by Acid-Buffered Saline, JID 2007:195 (15 April) and Rennie, P., Bowtell, P., Hull, D. et al. Low pH gel intranasal sprays inactivate influenza viruses in vitro and protect ferrets against influenza infection. Respir Res 8, 38 (2007). https://doi.org/10.1186/1465-9921-8-38 ). We do not claim any specific interaction with the ACE receptor or the S- protein but rather a nonspecific blockage that prevents viruses from reaching cell surface. This last claim is supported by studies we performed in several viruses including the SARS- CoV-2 virus cited in the article and posted on the company’s website. 3. Taffix is classified as medical device class 1 and as such is subject to marketing authorization process. That marketing authorization in Europe is posted on our website and referred to in the article including the approved indication “ Taffix ™ is legally marketed in Europe (CE- DE/CA09/0760/N18/001) with the following Indication for Use: TaffiX ™is indicated for use as a protective mechanical barrier against allergens and viruses (e.g., SARS-CoV-2) within the nasal cavity.” We will happy to provide you with our full whitepaper that summarizes the scientific background and additional information on our pre clinical and clinical work. Please feel free to contact me via email and I will send you the package. Again thank you for your comment and interest.
commented on 06 January, 2021
Is it not possible to purchase just one bottle? The price point is prohibitively high.
View 1 reply
Dalia Megiddo
replied on 07 January, 2021
I will forward your comment to our commercial people for reply. Thank you for your interest
Linda Gamlin
commented on 10 January, 2021
I note that the instructions that come with Taffix say "Do not refrigerate or freeze". If the product is inadvertently exposed to very low temperatures through being left in a vehicle during winter in the northern hemisphere (as has happened with one of my patients), will this inactivate the product or render it less effective?
View 1 reply
Dalia Megiddo
replied on 10 January, 2021
The only effect of cold or humid temperature would be on the flowability of the powder- namely it could be agglomerate and will not fly freely from the bottle. If this is the case- please instruct your patient to approach our customer service and we will be happy to replace his bottle.
Linda Gamlin
commented on 10 January, 2021
I note that the instructions that come with Taffix say "Do not refrigerate or freeze". If the product is inadvertently exposed to very low temperatures through being left in a vehicle during winter in the northern hemisphere (as has happened with one of my patients), will this inactivate the product or render it less effective?
Miranda
commented on 15 January, 2021
Could I ask how many people in the study had previously contracted covid-19?
View 1 reply
Dalia Megiddo
replied on 15 January, 2021
We do not have the numbers for this specific study population however in the city of Bney Brak there were 17% positivity rate at the eve of the study and 28% at the end of the two weeks follow up period.
Raphaela
commented on 16 January, 2021
I would like to purchase just one bottle. It is just for me. Is there any chance you will start selling just one bottle? Thanks!
View 1 reply
Dalia Megiddo
replied on 17 January, 2021
Please send this question through the company's info mailbox on the website
Mr Colm Tumbleton
commented on 20 January, 2021
Just ordered some Taffix. Does the Hydroxypropyl methylcellulose in any way interfere with breathing with, say, sinusitis? I think I read somewhere that the sealing effect prevents allergies and so presumably might ease breathing as also would the menthol.
Dalia Megiddo
replied on 02 January, 2021
Your comment regarding the selection bias of the people who chose to use Taffix is correct. This potential selection bias is discussed in our paper as well. As for the total community: The prayer place was divided into capsule with plastic dividers and people were assign to one capsule and were not allowed to mingle. Mask wearing was mandatory for all and was enforced equally across the whole participants.
View 1 reply
Linda Gamlin
replied on 02 January, 2021
Thanks. May I suggest that it would be useful to add those details to the published paper.