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

Primary Purpose

COVID-19 (SARS-CoV-2 Infection)

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Sentinox--Group A

Sentinox--Group B

About this trial

This is an interventional treatment trial for COVID-19 (SARS-CoV-2 Infection)

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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;
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.

Sites / Locations

Ospedale Policlinico San Martino IRCCS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load (copies/mL) in nasal fluids in mild COVID-19 patients

Secondary Outcome Measures

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 profile of Sentinox to affect the profile of viral load analysing the subjects' negativization (expressed as number of negativized patients)

Time profile of Sentinox to affect the profile of viral load analysing the infectiousness of the patients (expressed as number of infective patients)

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 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 profile of Sentinox to affect the duration of clinical features of disease using an ad hoc questionnaire during all study duration

Tolerability of the Sentinox a Visual Analogue Scale (VAS) will be used (score 0=not tolerable; score 10=totally tolerable)

The patient satisfaction will be evaluated with a 5-points Likert Scale (score 1=not satisfied; score 5=fully satisfied)

Safety will be monitored through Adverse Events including assessment of relationship to the IP

Safety will be monitored through clinical examination: difficulty breathing

Safety will be monitored through clinical examination: body temperature

Safety will be monitored through clinical examination: headache

Safety will be monitored through clinical examination: oxygen saturation

Full Information

NCT ID

NCT04909996

First Posted

May 28, 2021

Last Updated

July 25, 2022

Sponsor

APR Applied Pharma Research s.a.

1. Study Identification

Unique Protocol Identification Number

NCT04909996

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

May 20, 2021 (Actual)

Primary Completion Date

November 30, 2021 (Actual)

Study Completion Date

November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

APR Applied Pharma Research s.a.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 (SARS-CoV-2 Infection)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy)

Arm Type

Experimental

Arm Title

Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy)

Arm Type

Experimental

Arm Title

Group C: no Sentinox treatment; only the standard therapy will be performed

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Sentinox--Group A

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Sentinox--Group B

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

Tolerability of the Sentinox a Visual Analogue Scale (VAS) will be used (score 0=not tolerable; score 10=totally tolerable)

Time Frame

Day 6

Title

The patient satisfaction will be evaluated with a 5-points Likert Scale (score 1=not satisfied; score 5=fully satisfied)

Time Frame

Day 6

Title

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

Title

Safety will be monitored through clinical examination: difficulty breathing

Time Frame

Day 1,2,3,4,5,6,10 and 21

Title

Safety will be monitored through clinical examination: body temperature

Time Frame

Day 1,2,3,4,5,6,10 and 21

Title

Safety will be monitored through clinical examination: headache

Time Frame

Day 1,2,3,4,5,6,10 and 21

Title

Safety will be monitored through clinical examination: oxygen saturation

Time Frame

Day 1,2,3,4,5,6,10 and 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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; 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.

Facility Information:

Facility Name

Ospedale Policlinico San Martino IRCCS

City

Genova

ZIP/Postal Code

16132

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

35632774

Citation

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.

Results Reference

derived

Links:

URL

https://doi.org/10.3390/v14051033

Description

Results on the study have been already published - Viruses 2022, 14, 1033. For this reason the result section of your form has been removed.

Learn more about this trial

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

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