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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy) | Experimental |
| |
| Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy) | Experimental |
| |
| Group C: no Sentinox treatment; only the standard therapy will be performed | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinox--Group A | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Sentinox versus Standard Treatment in term of reduction in viral load (copies/mL) in nasal fluids in mild COVID-19 patients | Day 1,2,3,4 and 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Policlinico San Martino IRCCS | Genova | 16132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35632774 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Sentinox--Group B | Device | 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). |
|
| 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) | 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 | 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) | 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 | 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) | Day 6 |
| The patient satisfaction will be evaluated with a 5-points Likert Scale (score 1=not satisfied; score 5=fully satisfied) | Day 6 |
| Safety will be monitored through Adverse Events including assessment of relationship to the IP | Day 1,2,3,4,5,6,10 and 21 |
| Safety will be monitored through clinical examination: difficulty breathing | Day 1,2,3,4,5,6,10 and 21 |
| Safety will be monitored through clinical examination: body temperature | Day 1,2,3,4,5,6,10 and 21 |
| Safety will be monitored through clinical examination: headache | Day 1,2,3,4,5,6,10 and 21 |
| Safety will be monitored through clinical examination: oxygen saturation | Day 1,2,3,4,5,6,10 and 21 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |