COVID-19 (SARS-CoV-2 Infection)NCT04909996

Study on the Performance and Safety of Sentinox in COVID-19 Patients

A study testing Sentinox--Group A and Sentinox--Group B in people with COVID-19 (SARS-CoV-2 Infection), run by APR Applied Pharma Research s.a. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-center, randomized, controlled, open-label, pilot study to assess the safety and the performance of Sentinox medical device in the treatment of mild COVID-19 patients. The study will consist of 9 visits. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: COVID-19 (SARS-CoV-2 Infection)
What is being tested?: Sentinox--Group A and Sentinox--Group B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteItaly
Study dates: 20 May 2021to 30 Nov 2021
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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patient Informed consent form (ICF) signed;
M \& F Aged ≥ 18 years and ≤ 64 years at the time of the signature of 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;
Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version of 27 May 2020). In the study COVID-19 patient with RT-PCR Ct value ≤ 30 for at least 2 genes out of 4, at the first swab will be enrolled. The enrollment of COVID-19 vaccinated patients will be allowed if they will present a "clinical vaccination failure", defined according to the indications reported in the "Global Manual on Surveillance of AE Following Immunization" (WHO guidelines).
Onset of symptoms from not more than 2/3 days

Who cannot join

Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases);
Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values;
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 for COVID-19;

Show all 15Show fewer

Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day;
Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 hours;
Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV);
Concurrent or planned treatment with other agents with actual or possible direct antiviral activity;
Prior hospitalization for COVID-19;
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 and / or known allergies to the trial product or its components;
Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale Policlinico San Martino IRCCS
Genova, 16132

Other trials in Italy

About this study

Official title: Post-market, Confirmatory, Interventional, Randomized and Controlled Clinical Study to Assess the Efficacy and Safety of Sentinox in COVID-19 Patients.

This is a single-center, randomized, controlled, open-label, pilot study to assess the safety and the performance of Sentinox medical device in the treatment of mild COVID-19 patients.

The study will consist of 9 visits. At the screening visit, according to the investigational site procedures, patients with a positive COVID-19 nasopharyngeal swab (quantitative swab test with RT-PCR Ct value ≤ 30 for at least 2 genes out of 4) performed at the investigational site on the same day will be summoned. Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. According to the investigator's judgment, the patient's clinical outcomes, and the investigational site guidelines, the enrolled patients should be hospitalized or redirected to other structures (e.g. "COVID-19 hotel", patient's home).

At Visit 0 (day 0), the patient will be randomized with a 1:1:1 ratio in one of 3 trial groups:

Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy);
Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy);
Group C: no Sentinox treatment; only the standard therapy will be performed.

The allocation of the patient in one of the three study arms will be performed sequentially by the principal investigator or delegates in the order in which the subjects are enrolled and will be reported in a randomization list, including the identification code of the patient and the treatment arm (A, B or C) assigned.

At Visit 1 (day 1) and Visit 2 (day 2), three nasopharyngeal swabs will be performed. At subsequent planned visits only one nasopharyngeal swab will be performed in the morning. From Visit 1 (day 1) to Visit 5 (day 5), patients will record daily adverse events (AE), concomitant medication, and presence of clinical features COVID-19 related in a diary.

After the end of the treatment visit (Visit 5), three follow-up visits will be performed on day 6, day 10, and day 21 respectively.

Conditions: COVID-19 (SARS-CoV-2 Infection)
Being tested: Sentinox--Group A, Sentinox--Group B
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sentinox--Group ADevice
GROUP A: Sentinox treatment performed 3 times/day for 5 days (as addon to the standard therapy) at 8am, 2pm and 8pm;
The application of IP on should be performed in accordance to the following indication:
The treatment is administered in a dose of 0.5 ml into each nostril (5 sprays) per the number of times per day according the trial group assigned according the randomization procedure (i.e., GROUP A: 3 times/day; GROUP B: 5 times/day; GROUP C: no IP treatment).
Sentinox--Group BDevice
GROUP B: Sentinox treatment performed 5 times/day for 5 days (as addon to the standard therapy) at 8am, 11am, 2pm, 5pm and 8pm;
The application of IP on should be performed in accordance to the following indication:
The treatment is administered in a dose of 0.5 ml into each nostril (5 sprays) per the number of times per day according the trial group assigned according the randomization procedure (i.e., GROUP A: 3 times/day; GROUP B: 5 times/day; GROUP C: no IP treatment).

Study groups in NCT04909996
Study group	Role	What they receive
Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy)	Experimental	Not described Receives: Device: Sentinox--Group A
Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy)	Experimental	Not described Receives: Device: Sentinox--Group B
Group C: no Sentinox treatment; only the standard therapy will be performed	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load (copies/mL) in nasal fluids in mild COVID-19 patients
Measured: Day 1,2,3,4 and 5

Secondary outcomes (13)

Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load in nasal fluids in mild COVID-19 patients stratifying the results according to the initial viral load
Measured: Day 1,2,3,4,5,6,10 and 21
Time profile of Sentinox to affect the profile of viral load analysing the subjects' negativization (expressed as number of negativized patients)
Measured: Day 1,2,3,4,5,6,10 and 21
Time profile of Sentinox to affect the profile of viral load analysing the infectiousness of the patients (expressed as number of infective patients)
Measured: Day 1,2,3,4,5,6,10 and 21
To compare the two treatments schedule of Sentinox: 3 irrigations die versus 5 irrigation die in term of reduction in viral load (copies/mL) in nasal fluids
Measured: Day 1,2,3,4 and 5
Time profile of Sentinox to affect the profile of viral load (copies/mL) during the duration of the study (treatment period and follow-up period)
Measured: Day 1,2,3,4,5,6,10 and 21
Time profile of Sentinox to affect the duration of clinical features of disease using an ad hoc questionnaire during all study duration
Measured: Day 1,2,3,4,5,6,10 and 21
Tolerability of the Sentinox a Visual Analogue Scale (VAS) will be used (score 0=not tolerable; score 10=totally tolerable)
Measured: Day 6
The patient satisfaction will be evaluated with a 5-points Likert Scale (score 1=not satisfied; score 5=fully satisfied)
Measured: Day 6
Safety will be monitored through Adverse Events including assessment of relationship to the IP
Measured: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: difficulty breathing
Measured: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: body temperature
Measured: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: headache
Measured: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: oxygen saturation
Measured: Day 1,2,3,4,5,6,10 and 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202130 Nov 2021

First posted2 Jun 2021
Study start20 May 2021
Primary completion30 Nov 2021
Study completion30 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19 (SARS-CoV-2 Infection)Studies 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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04909996
Sponsor's protocol ID: STX-2021
Status last verified: Jul 2022
First submitted: 28 May 2021
Last updated: 27 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Panatto D, Orsi A, Bruzzone B, Ricucci V, Fedele G, Reiner G, Giarratana N, Domnich A, Icardi G, Stx Study Group. Efficacy of the Sentinox Spray in Reducing Viral Load in Mild COVID-19 and Its Virucidal Activity against Other Respiratory Viruses: Results of a Randomized Controlled Trial and an In Vitro Study. Viruses. 2022 May 12;14(5):1033. doi: 10.3390/v14051033.
PubMed 35632774

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market, Confirmatory, Interventional, Randomized and Controlled Clinical Study to Assess the Efficacy and Safety of Sentinox in COVID-19 Patients.
ClinicalTrials.gov ID: NCT04909996
Acronym / sponsor ID: STX-2021
Conditions: COVID-19 (SARS-CoV-2 Infection)
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: APR Applied Pharma Research s.a.University, hospital or other
Study start: 20 May 2021 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 30 Nov 2021 (actual)
First posted: 2 Jun 2021 (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 single-center, randomized, controlled, open-label, pilot study to assess the safety and the performance of Sentinox medical device in the treatment of mild COVID-19 patients.

At Visit 0 (day 0), the patient will be randomized with a 1:1:1 ratio in one of 3 trial groups:

Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy);
Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy);
Group C: no Sentinox treatment; only the standard therapy will be performed.

After the end of the treatment visit (Visit 5), three follow-up visits will be performed on day 6, day 10, and day 21 respectively.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy)	Experimental	Device: Sentinox--Group A
Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy)	Experimental	Device: Sentinox--Group B
Group C: no Sentinox treatment; only the standard therapy will be performed	No intervention	–

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Patient Informed consent form (ICF) signed;
M \& F Aged ≥ 18 years and ≤ 64 years at the time of the signature of 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;
Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version of 27 May 2020). In the study COVID-19 patient with RT-PCR Ct value ≤ 30 for at least 2 genes out of 4, at the first swab will be enrolled. The enrollment of COVID-19 vaccinated patients will be allowed if they will present a "clinical vaccination failure", defined according to the indications reported in the "Global Manual on Surveillance of AE Following Immunization" (WHO guidelines).
Onset of symptoms from not more than 2/3 days

Key exclusion criteria (15 listed)

Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases);
Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values;
Immune system illnesses;
Known drug and/or alcohol abuse;
Individuals who are cognitively impaired and/or who are unable to give informed consent;

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
Sentinox--Group AGROUP A: Sentinox treatment performed 3 times/day for 5 days (as addon to the standard therapy) at 8am, 2pm and 8pm; The application of IP on should be performed in accordance to the following indication: The treatment is administered in a dose of 0.5 ml into each nostril (5 sprays) per the number of times per day according the trial group assigned according the randomization procedure (i.e., GROUP A: 3 times/day; GROUP B: 5 times/day; GROUP C: no IP treatment).	Device	Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy)
Sentinox--Group BGROUP B: Sentinox treatment performed 5 times/day for 5 days (as addon to the standard therapy) at 8am, 11am, 2pm, 5pm and 8pm; The application of IP on should be performed in accordance to the following indication: The treatment is administered in a dose of 0.5 ml into each nostril (5 sprays) per the number of times per day according the trial group assigned according the randomization procedure (i.e., GROUP A: 3 times/day; GROUP B: 5 times/day; GROUP C: no IP treatment).	Device	Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy)

Primary outcome

Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load (copies/mL) in nasal fluids in mild COVID-19 patients
Time frame: Day 1,2,3,4 and 5

13 secondary outcomes

Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load in nasal fluids in mild COVID-19 patients stratifying the results according to the initial viral load
Time frame: Day 1,2,3,4,5,6,10 and 21
Time profile of Sentinox to affect the profile of viral load analysing the subjects' negativization (expressed as number of negativized patients)
Time frame: Day 1,2,3,4,5,6,10 and 21
Time profile of Sentinox to affect the profile of viral load analysing the infectiousness of the patients (expressed as number of infective patients)
Time frame: Day 1,2,3,4,5,6,10 and 21
To compare the two treatments schedule of Sentinox: 3 irrigations die versus 5 irrigation die in term of reduction in viral load (copies/mL) in nasal fluids
Time frame: Day 1,2,3,4 and 5
Time profile of Sentinox to affect the profile of viral load (copies/mL) during the duration of the study (treatment period and follow-up period)
Time frame: Day 1,2,3,4,5,6,10 and 21
Time profile of Sentinox to affect the duration of clinical features of disease using an ad hoc questionnaire during all study duration
Time frame: Day 1,2,3,4,5,6,10 and 21
Tolerability of the Sentinox a Visual Analogue Scale (VAS) will be used (score 0=not tolerable; score 10=totally tolerable)
Time frame: Day 6
The patient satisfaction will be evaluated with a 5-points Likert Scale (score 1=not satisfied; score 5=fully satisfied)
Time frame: Day 6
Safety will be monitored through Adverse Events including assessment of relationship to the IP
Time frame: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: difficulty breathing
Time frame: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: body temperature
Time frame: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: headache
Time frame: Day 1,2,3,4,5,6,10 and 21
Safety will be monitored through clinical examination: oxygen saturation
Time frame: Day 1,2,3,4,5,6,10 and 21

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Derived from this study: PubMed 35632774Panatto D, Orsi A, Bruzzone B, Ricucci V, Fedele G, Reiner G, Giarratana N, Domnich A, Icardi G, Stx Study Group. Efficacy of the Sentinox Spray in Reducing Viral Load in Mild COVID-19 and Its Virucidal Activity against Other Respiratory Viruses: Results of a Randomized Controlled Trial and an In Vitro Study. Viruses. 2022 May 12;14(5):1033. doi: 10.3390/v14051033.

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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--Group A and Sentinox--Group B in people with COVID-19 (SARS-CoV-2 Infection), 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 27 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load (copies/mL) in nasal fluids in mild COVID-19 patients (time frame: Day 1,2,3,4 and 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04909996, which also lists 1 linked publication.

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 27 Jul 2022.