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

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.

Conditions

• COVID-19 (SARS-CoV-2 Infection)

Interventions

DEVICE

Sentinox--Group A

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).

DEVICE

Sentinox--Group B

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).

Sponsors & Collaborators

• APR Applied Pharma Research s.a.

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-20

Primary Completion

2021-11-30

Completion

2021-11-30

Countries

• Italy

Study Locations