COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).

Not Applicable

Completed

• Conditions: Upper Respiratory Tract Infections; COVID-19
• Interventions: Device: TaffiX™

• Registration Number: NCT05252468
• Lead Sponsor: Nasus Pharma

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.

Study Timeline

• Study Start: 2021-05-19
• Primary Completion: 2021-11-02
• Study Completion: 2021-12-02
• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-02-23
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 693

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TaffiX™	TaffiX™	TaffiX™ is a Nasal powder personal spray that blocks viruses particles from entering the nasal cells.
Lactose powder	TaffiX™	Lactose nasal powder will be used as a placebo. It has an identical appearance as TaffiX™ (white powder in an identical bottle).

Primary Outcome Measures

Name	Time	Method
COVID-19 new cases	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.

Secondary Outcome Measures

Name	Time	Method
The safety and tolerability of the study device.	Through study completion, 6 weeks.	Incidence of adverse events as reported by subjects

Trial Locations

Locations (1)

Diagnostics and Consultation Center Convex Ltd; 🇧🇬 Sofia, Bulgaria