COVID-19NCT05252468
COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
A study testing TaffiX™ in people with COVID-19 and Upper Respiratory Tract Infections, run by Nasus Pharma at 1 site in Bulgaria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Upper Respiratory Tract Infections
- What is being tested?
- TaffiX™
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 693 participants
- Where
- 1 siteBulgaria
- Study dates
- 19 May 2021to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects 12 yr and older who had not previously been infected with COVID-19 to the best of their knowledge.
- Were not vaccinated yet against COVID-19 and will not be vaccinated during the study (if they decide to get the vaccine during the study they will be excluded a week later).
- Negative serology rapid test to COVID-19.
- Be informed of the nature of the study and the procedures and sign an informed consent form.
- Willing and able to adhere to Protocol requirements.
- If female of childbearing potential, agree to use an acceptable method of birth control or be surgically sterile, and have a negative pregnancy test.
Who cannot join
- Known sensitivity to citric acid and/or sodium citrate and /or benzalkonium chloride and /or Hydroxypropylmethylcellulose (HPMC) or lactose (does not mean diagnosed lactose intolerance in food).
- Females who are pregnant or are lactating as reported by the subject.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- COVID-19, Upper Respiratory Tract Infections
- Being tested
- TaffiX™
- Keywords
- Upper respiratory tract infection, viruses, COVID-19, nasal, powder, prevention, SARS-CoV-2
- Medical subject headings
- COVID-19, Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaffiX™Device
Personal nasal powder spray.
| Study group | Role | What they receive |
|---|---|---|
| TaffiX™ | Experimental | TaffiX™ is a Nasal powder personal spray that blocks viruses particles from entering the nasal cells. Receives: Device: TaffiX™ |
| Lactose powder | Placebo comparator | Lactose nasal powder will be used as a placebo. It has an identical appearance as TaffiX™ (white powder in an identical bottle). Receives: Device: TaffiX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 new cases
symptoms score (Fever; Cough; Rigors; Myalgia; Headache; Vomiting or Diarrhea; Shortness of breath; Breathing difficulties; New olfactory and taste disorder(s); Runny or stuffy nose; Sore throat) as reported in Bi-weekly questionnaires, PCR or antigen test at symptomatic subjects, serology test at end of the study.
Measured: Through study completion, 6 weeks
Secondary outcomes (1)
The safety and tolerability of the study device.
Incidence of adverse events as reported by subjects
Measured: Through study completion, 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start19 May 2021
- Primary completion2 Nov 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emil Kolev, MD, Principal investigator, Nasus Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252468
- Sponsor's protocol ID
- NP-003-Taffix
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
- ClinicalTrials.gov ID
- NCT05252468
- Acronym / sponsor ID
- NP-003-Taffix
- Conditions
- COVID-19, Upper Respiratory Tract Infections
- Keywords
- Upper respiratory tract infection, viruses, COVID-19, nasal, powder, prevention, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Nasus PharmaIndustry (pharma, biotech, devices)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TaffiX™ | Experimental | Device: TaffiX™TaffiX™ is a Nasal powder personal spray that blocks viruses particles from entering the nasal cells. |
| Lactose powder | Placebo comparator | Device: TaffiX™Lactose nasal powder will be used as a placebo. It has an identical appearance as TaffiX™ (white powder in an identical bottle). |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects 12 yr and older who had not previously been infected with COVID-19 to the best of their knowledge.
- Were not vaccinated yet against COVID-19 and will not be vaccinated during the study (if they decide to get the vaccine during the study they will be excluded a week later).
- Negative serology rapid test to COVID-19.
- Be informed of the nature of the study and the procedures and sign an informed consent form.
- Willing and able to adhere to Protocol requirements.
Key exclusion criteria (2 listed)
- Known sensitivity to citric acid and/or sodium citrate and /or benzalkonium chloride and /or Hydroxypropylmethylcellulose (HPMC) or lactose (does not mean diagnosed lactose intolerance in food).
- Females who are pregnant or are lactating as reported by the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaffiX™Personal nasal powder spray. | Device | Lactose powder, TaffiX™ |
Primary outcome
COVID-19 new cases
Time frame: Through study completion, 6 weeks
symptoms score (Fever; Cough; Rigors; Myalgia; Headache; Vomiting or Diarrhea; Shortness of breath; Breathing difficulties; New olfactory and taste disorder(s); Runny or stuffy nose; Sore throat) as reported in Bi-weekly questionnaires, PCR or antigen test at symptomatic subjects, serology test at end of the study.
1 secondary outcome
The safety and tolerability of the study device.
Time frame: Through study completion, 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil Kolev, MD principal investigator
Nasus Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaffiX™ in people with COVID-19 and Upper Respiratory Tract Infections, run by Nasus Pharma at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 new cases (time frame: Through study completion, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.