Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection

Double-Blinded, Placebo-Controlled Parallel, Phase II Clinical Efficacy Study Evaluating NORS To Treat and Prevent the Exacerbation of Infection in Individuals With Documented Mild COVID-19

This is a double-blinded, placebo-controlled parallel, phase II clinical efficacy study evaluating Nitric Oxide Nasal Irrigation (NONI) for the treatment of COVID-19 in individuals with mild COVID-19 Infection.

Up to 50 subjects will be enrolled into one of two cohorts of this study in a ratio of 1:1 (Treatment: Placebo Control). Subjects will be screened and randomized into one of two parallel cohorts.

• Treatment (N = up to 25): Subjects will be enrolled and receive daily NONI treatment for 14 days with a follow-up visit on Day 28 post randomization.
• Placebo (N = up to 25): Subjects will be enrolled and receive a placebo for 14 days with a follow-up visit on Day 28 post randomization.

Inclusion Criteria:

• Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol;

• Men and Women ≥ 18years of age;

• Internet access and capability and willingness to use to participate in audio or audio/video engagements with medical professionals, receive texts, emails, and phone calls from study staff and have a device and reasonable cellular data or other internet access to submit daily study required information using a smart phone, tablet, laptop, or desktop computer during the study period;

• COVID-19 infection confirmed with a laboratory antigen or SARS-CoV-2 RT-PCR nasal swab;

• Specimen collected within the past 48 hours;

• Mild COVID /FLU symptoms which may include no symptoms, fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, lack of taste or smell without shortness of breath or dyspnea;

• Must be willing to use one highly effective birth control method which include: abstinence, hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or to use two forms of effective birth control methods which include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge);

  • Hormonal methods and the IUD must be in use at least 30 days prior to first Study drug administration
  • Abstinence and barrier methods must be in use at least 14 days prior to Study drug administration
  • Vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.

Exclusion Criteria:

• Current tracheostomy or laryngectomy;
• Concomitant respiratory therapy such as oxygen or ventilatory support. Positive airway pressure for obstructive sleep apnea is permitted if treatment was established with good compliance at least 3 months before enrolment;
• Need for hospitalization for any reason;
• Inability to safely self-administer nasal irrigation
• Any clinical contraindications, as judged by the Qualified Medical Practitioner;
• Clinical signs indicative of moderate, severe or critical COVID severity symptoms (as defined by FDA COVID-19 Guidance Document)
• Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study;
• Lactating, pregnant or planning to become pregnant during the study period;
• Diagnosed with prior COVID-19 infection (>48 hours from the time the test is reported prior to the time of screening).