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

NCT04909996 | Completed

• 1 other identifier: STX-2021
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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:

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

Conditions

COVID-19 (SARS-CoV-2 Infection)

Outcome Measures

Primary Outcomes (1)

• 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

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

  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)

  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

Study Arms (3)

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

Interventions

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).

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

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).

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• APR Applied Pharma Research s.a.: lead

Study Sites (1)

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

Location

Related Publications (1)

• 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.

  PMID: 35632774 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 2, 2021
• Study Start: May 20, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

IT (1)