Healthy VolunteersNCT05499780
Study on Performance and Safety of Sentinox in the Prevention of Acute Respiratory Infections (ARI)
A study testing Sentinox in people with Healthy Volunteers, run by APR Applied Pharma Research s.a. at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sentinox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2022to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-market, Randomized and Controlled Clinical Study to Assess the Performance and Safety of Sentinox in the Prevention of Acute Respiratory Infections
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
Read the detailed description
The study will consist of:
- A screening visit (Visit 0, on-site) to sign the informed consent form (ICF). The operator will:
- review the inclusion/exclusion criteria
- 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
- Being tested
- Sentinox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Sentinox |
| Group B:no Sentinox treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily for a surveillance 21-days period
Secondary outcomes (5)
Performance of Sentinox in preventing ARI caused by different respiratory viruses
Measure the Proportion of patients with 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]) and confirmed by positive swab for each specific strain of virus
Measured: Daily for a surveillance 21-days period
Performance of Sentinox intranasal administration against bacterial infection
Measure the Proportion of patients with 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]), not confirmed by a positive swab for at least 1 virus, but with positive swab for at least 1 bacterium.
Measured: Daily for a surveillance 21-days period
Performance of Sentinox in preventing clinically defined ARI without microbiological confirmation
Measure of Proportion of patients with 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]), not confirmed by positive swab for any of the tested virus or bacteria
Measured: Daily for a surveillance 21-days period
Subjects' satisfaction of self -administering Sentinox
Measure the product satisfaction of subjects self-administering Sentinox by a 5-points Likert Scale
Measured: Daily for a surveillance 21-days period
Tolerability and safety of Sentinox
Measure the Incidence and severity of AEs or incidents related to the use of the nasal solution, hypersensitivity and adverse reactions.
Measured: Daily for a surveillance 21-days period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start7 Nov 2022
- Primary completion27 Feb 2023
- Study completion13 Sep 2023
Why it stopped: Difficulty in enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- APR Applied Pharma Research s.a.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499780
- Sponsor's protocol ID
- STX-2022
- Status last verified
- Oct 2023
- First submitted
- 8 Aug 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market, Randomized and Controlled Clinical Study to Assess the Performance and Safety of Sentinox in the Prevention of Acute Respiratory Infections
- ClinicalTrials.gov ID
- NCT05499780
- Acronym / sponsor ID
- STX-2022
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolment
- Enrolment
- 144 participants (actual)
- Lead sponsor
- APR Applied Pharma Research s.a.University, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- review the inclusion/exclusion criteria
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: treatment with Sentinox performed 3 times/day for 21 days | Experimental | Device: Sentinoxtreatment with Investigational Medical Device (IMD) performed 3 times/day for 21 days at 8 am, 2 pm and 8 pm |
| Group B:no Sentinox treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SentinoxThe 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. | Device | Group A: treatment with Sentinox performed 3 times/day for 21 days |
Primary outcome
Performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus
Time frame: Daily for a surveillance 21-days period
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.
5 secondary outcomes
Performance of Sentinox in preventing ARI caused by different respiratory viruses
Time frame: Daily for a surveillance 21-days period
Performance of Sentinox intranasal administration against bacterial infection
Time frame: Daily for a surveillance 21-days period
Performance of Sentinox in preventing clinically defined ARI without microbiological confirmation
Time frame: Daily for a surveillance 21-days period
Subjects' satisfaction of self -administering Sentinox
Time frame: Daily for a surveillance 21-days period
Tolerability and safety of Sentinox
Time frame: Daily for a surveillance 21-days period
Results and safety
The study was stopped early (reason given: Difficulty in enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinox in people with Healthy Volunteers, run by APR Applied Pharma Research s.a. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty in enrolment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of self-administered Sentinox intranasal spray in preventing ARI caused by at least one respiratory virus (time frame: Daily for a surveillance 21-days period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.