NCT05252468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
693

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

February 10, 2022

Last Update Submit

February 23, 2022

Conditions

COVID-19Upper Respiratory Tract Infections

Keywords

Upper respiratory tract infectionvirusesCOVID-19nasalpowderpreventionSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, 6 weeks

Secondary Outcomes (1)

  • The safety and tolerability of the study device.

    Through study completion, 6 weeks.

Other Outcomes (3)

  • To evaluate the efficacy of Taffix in preventing upper respiratory infection

    Through study completion, 6 weeks

  • Severity of COVID-19

    Through study completion, 6 weeks

  • Change in Allergic Rhinitis or Asthma symptoms in relevant subjects

    Through study completion, 6 weeks

Study Arms (2)

TaffiX™

EXPERIMENTAL

TaffiX™ is a Nasal powder personal spray that blocks viruses particles from entering the nasal cells.

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).

Device: TaffiX™

Interventions

TaffiX™DEVICE

Personal nasal powder spray.

Lactose powderTaffiX™

Eligibility Criteria

Age12 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnostics and Consultation Center Convex Ltd

Sofia, Bulgaria

Location

MeSH Terms

Conditions

COVID-19Respiratory Tract InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Emil Kolev, MD

    Nasus Pharma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Double blind.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 23, 2022

Study Start

May 19, 2021

Primary Completion

November 2, 2021

Study Completion

December 2, 2021

Last Updated

March 10, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)