Study on the Performance and Safety of Sentinox in COVID-19 Patients
Condition: COVID-19 (SARS-CoV-2 Infection)
MeSH terms: COVID-19
Study type: Interventional

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


Intervention name(s): Sentinox--Group A; Sentinox--Group B
Intervention type(s): Device; Device
Intervention description(s): 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 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment