Status:

COMPLETED

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

Lead Sponsor:

Nasus Pharma

Conditions:

COVID-19

Upper Respiratory Tract Infections

Eligibility:

All Genders

12-120 years

Phase:

NA

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 ...

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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.

Key Trial Info

Start Date :

May 19 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 2 2021

Estimated Enrollment :

693 Patients enrolled

Trial Details

Trial ID

NCT05252468

Start Date

May 19 2021

End Date

December 2 2021

Last Update

March 10 2022

Active Locations (1)

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Diagnostics and Consultation Center Convex Ltd

Sofia, Bulgaria