NCT05499780

Brief Summary

This is a post market, single-center, randomized, controlled, clinical study to assessTo evaluate the performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

November 24, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

August 8, 2022

Last Update Submit

November 21, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus

    Measure the proportion of patients with at least one symptoms of ARI (i.e., cough, sore throat, shortness of breath, coryza, as described in the European Commission guideline on relevant case definitions of communicable diseases \[Commission Implementing Decision (EU) 2018/945 of 22 June 2018\]) and confirmed by positive swab for at least 1 virus.

    Daily for a surveillance 21-days period

Secondary Outcomes (5)

  • Performance of Sentinox in preventing ARI caused by different respiratory viruses

    Daily for a surveillance 21-days period

  • Performance of Sentinox intranasal administration against bacterial infection

    Daily for a surveillance 21-days period

  • Performance of Sentinox in preventing clinically defined ARI without microbiological confirmation

    Daily for a surveillance 21-days period

  • Subjects' satisfaction of self -administering Sentinox

    Daily for a surveillance 21-days period

  • Tolerability and safety of Sentinox

    Daily for a surveillance 21-days period

Study Arms (2)

Group A: treatment with Sentinox performed 3 times/day for 21 days

EXPERIMENTAL

treatment with Investigational Medical Device (IMD) performed 3 times/day for 21 days at 8 am, 2 pm and 8 pm

Device: Sentinox

Group B:no Sentinox treatment

NO INTERVENTION

Interventions

SentinoxDEVICE

The treatment will be administered in a dose of 0.5 ml into each nostril (5 sprays) per 3 times/day (8 am, 2 pm and 8 pm), for 21 days from Visit 1.

Group A: treatment with Sentinox performed 3 times/day for 21 days

Eligibility Criteria

Age18 Years - 63 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ICF signed.
  • Males and females aged ≥ 18 years and \<64 years at the time of the signature of the ICF.
  • Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and calls for the duration of the study by telephone contact and install the Mobile App to use the e-diary.

You may not qualify if:

  • Reporting of any symptoms of ARI in the 15 days preceding the Visit 1.
  • Reporting the intake of any drugs, among antiviral or antibacterial therapies, that may interfere with the study results in the 15 days preceding the Visit 1.
  • Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease).
  • Immune system illnesses.
  • Known drug and/or alcohol abuse.
  • Individuals who are cognitively impaired and/or who are unable to give informed consent.
  • Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from Visit 1.
  • Concurrent or planned treatment with other agents with actual or possible direct antiviral/antibacterial activity.
  • Positive pregnancy test or breastfeeding woman.
  • Known hypersensitivity to the study treatment, its metabolites, or formulation excipient.
  • History of severe drug and / or food allergies.
  • Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the Subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 12, 2022

Study Start

November 7, 2022

Primary Completion

February 27, 2023

Study Completion

September 13, 2023

Last Updated

November 24, 2023

Record last verified: 2023-10

Locations

IT(1)