Clinical trial NCT05252468: COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
Official title: COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Upper Respiratory Tract Infections
Keywords: Upper respiratory tract infection
viruses
COVID-19
nasal
powder
prevention
SARS-CoV-2
Lead sponsor: Nasus Pharma
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 693
Sex: ALL
Minimum age (years): 12
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects 12 yr and older who had not previously been infected with COVID-19 to the best of their knowledge.
2. 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).
3. Negative serology rapid test to COVID-19.
4. Be informed of the nature of the study and the procedures and sign an informed consent form.
5. Willing and able to adhere to Protocol requirements.
6. If female of childbearing potential, agree to use an acceptable method of birth control or be surgically sterile, and have a negative pregnancy test.

Exclusion Criteria:

1. 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).
2. Females who are pregnant or are lactating as reported by the subject.

Primary outcomes:
measure: COVID-19 new cases
timeFrame: Through study completion, 6 weeks
Secondary outcomes:
measure: The safety and tolerability of the study device.
timeFrame: Through study completion, 6 weeks.
Other outcomes:
measure: To evaluate the efficacy of Taffix in preventing upper respiratory infection
timeFrame: Through study completion, 6 weeks
measure: Severity of COVID-19
timeFrame: Through study completion, 6 weeks
measure: Change in Allergic Rhinitis or Asthma symptoms in relevant subjects
timeFrame: Through study completion, 6 weeks
Locations:
city: Sofia
country: Bulgaria
facility: Diagnostics and Consultation Center Convex Ltd
Study officials:
affiliation: Nasus Pharma
name: Emil Kolev, MD
role: PRINCIPAL_INVESTIGATOR
References: