nitric oxide releasing solution to treat and prevent exacerbation of mild covid-19 infection

Conditions: SARS-CoV Infection

Summary: 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.

Eligibility criteria:
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).