NCT05499780

Study on Performance and Safety of Sentinox in the Prevention of Acute Respiratory Infections (ARI)

Post-market, Randomized and Controlled Clinical Study to Assess the Performance and Safety of Sentinox in the Prevention of Acute Respiratory Infections

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: APR Applied Pharma Research s.a. · Academic / Other
• Sex: All
• Age: 18 Years – 63 Years
• Healthy volunteers: Accepted

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

Detailed description

The study will consist of: * A screening visit (Visit 0, on-site) to sign the informed consent form (ICF). The operator will: o review the inclusion/exclusion criteria o record the medical history, demographic data and concomitant medications (CMs), including previous anti-influenza, anti-COVID-19 and anti-pneumococcal vaccinations * A randomization visit (Visit 1, on-site) to start the surveillance period. As soon as an increase in the regional epidemiological curve of ARI is observed, screened subjects will be invited for Visit 1. At Visit 1 the operator will: * check that the inclusion/exclusion criteria are still met, to confirm eligibility * confirm the medical history and the concomitant medications including previous anti-influenza, anti-COVID-19 and anti-pneumococcal vaccinations * record the result of the pregnancy testing * randomize with a 1:1 ratio in one of 2 trial Groups: - Group A: treatment with Investigational Medical Device (IMD) performed 3 times/day for 21 days at 8 am, 2 pm and 8 pm \- Group B: no IMD treatment * invite the subjects to start: - treatment and surveillance period for 21 days, if belonging to Group A * surveillance period for 21 days, if belonging to Group B At Visit 1, an e-diary access will be delivered to both Groups to daily record Adverse Events (AEs), CMs other than treatments recorded in V1, presence of clinical features of ARI and IMD usage. The regular usage of the IMD will be recorded daily, as well as any change of the device and the reason for this. Study participants will install the Mobile App to complete the e-diary and will receive instructions to use the app. They will be instructed not to disclose their assignment to the treatment group to the blinded Investigator. The IMD bottles needed for the 21-days treatment will be delivered to the enrolled participants of Group A, who will be trained to self-administer the treatment. • A surveillance 21-days period, during which: * the subjects of Group A will perform the daily treatment for 21 days * the subjects of Group A and B will fill in a daily e-diary; the subjects will receive a reminder to follow the therapy (in the morning) and to complete the e-diary (in the evening) * as soon as the subject records at least one symptom 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 \[Commission Implementing Decision (EU) 2018/945 of 22 June 2018\]) in the Mobile App, the blinded Investigator will be advised and will contact the subject by telephone within 12 hours to verify that the illness is due to ARI and to accordingly update the eCRF. If during the phone contact the blinded Investigator judges the symptoms as correlated to ARI: * the subject will be invited to immediately stop the IMD treatment if belonging to Group A * the subject will be invited to the site for Visit 2 within 24 hours to perform a nasopharyngeal swab and to interrupt the surveillance period (Group A and B). If during the phone contact the blinded Investigator judges the symptoms as not correlated to ARI, the subject will continue the surveillance period and the IMD treatment (if belonging to Group A) till a maximum of 21 days. • A final visit (Visit 2, on-site). The subject, whose symptom of ARI during the surveillance period has been confirmed by the Investigator during the phone call, will attend for a site visit and be requested to: * have a nasopharyngeal swab taken * undergo a physical examination * fill in the Visual Analogue Scale (VAS) score for Sentinox tolerability (for subjects of Group A) * complete a 5-points Likert Scale for the satisfaction of Sentinox (for subjects of Group A) * return the used and unused treatment bottles (for subjects of Group A) The subject who does not have any symptom of ARI during the surveillance period, will perform a visit within 21±7 days from Visit 1 to: * fill in the VAS score for Sentinox tolerability (for subjects of Group A) * complete a 5-points Likert Scale for the satisfaction of Sentinox (for subjects of Group A) * return the used and unused treatment bottles (for subjects of Group A) At Visit 2, the Mobile App will be uninstalled from the electronic device used by the subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Sentinox	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.

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-02-27
• Completion: 2023-09-13
• First posted: 2022-08-12
• Last updated: 2023-11-24

Locations

1 site across 1 country: Italy