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Completed

NCT Number: NCT05252468

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Upper Respiratory Tract Infections Virus Diseases

Age range

12 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diagnostics and Consultation Center Convex Ltd

Sofia, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

TaffiX™

Device

Personal nasal powder spray.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The safety and tolerability of the study device.

    Time frame: Through study completion, 6 weeks.

    Incidence of adverse events as reported by subjects

Other outcomes

  1. To evaluate the efficacy of Taffix in preventing upper respiratory infection

    Time frame: Through study completion, 6 weeks

    Incidence of symptoms (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, at subjects who were negative to SARS-CoV-2

  2. Severity of COVID-19

    Time frame: Through study completion, 6 weeks

    Severity of COVID-19 cases (according to NIH severity categories)

  3. Change in Allergic Rhinitis or Asthma symptoms in relevant subjects

    Time frame: Through study completion, 6 weeks

    By report to the study coordinator, among subjects who reported of that condition at the entry to the study.

Sponsors and collaborators

Lead sponsor

Nasus Pharma

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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