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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05252468
• Other study ID #: NP-003-Taffix
• Status: Completed
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: February 2022
• Source: Nasus Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 693
• Est. completion date: December 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Device:
• TaffiX™
Personal nasal powder spray.

Locations

Country	Name	City	State
Bulgaria	Diagnostics and Consultation Center Convex Ltd	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Nasus Pharma

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate the efficacy of Taffix in preventing upper respiratory infection	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	Through study completion, 6 weeks
Other	Severity of COVID-19	Severity of COVID-19 cases (according to NIH severity categories)	Through study completion, 6 weeks
Other	Change in Allergic Rhinitis or Asthma symptoms in relevant subjects	By report to the study coordinator, among subjects who reported of that condition at the entry to the study.	Through study completion, 6 weeks
Primary	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	The safety and tolerability of the study device.	Incidence of adverse events as reported by subjects	Through study completion, 6 weeks.