Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection
Nitric Oxide Releasing Solutions to Prevent and Treat Mild/Moderate COVID-19 Infection
This is a multi-center, randomized, controlled, phase II clinical efficacy study evaluating a
 novel Nitric Oxide Releasing Solution (NORS) treatment for the prevention and treatment of
 COVID-19 in healthcare workers at risk of infection. Participants will be enrolled into one
 of two components of this study. Based on initial swabs/symptoms, volunteers who are COVID-19
 negative will be enrolled in the Prevention study and randomized to receive standard
 institutional precautions or standard institutional precautions + NORS. Those who are
 COVID-19 positive will be enrolled in the open-label Treatment Sub-Study.
The novel, human-infecting corona-virus, provisionally named 2019 novel corona virus
 (2019-nCoV) is a single-strand, positive-sense RNA virus and has a similar receptor-binding
 domain structure to that of SARS-CoV and MERS-CoV. The virus is transmitted via airborne
 droplets to the nasal mucosa. Replication occurs locally in the nasal mucosa, in ciliated
 epithelial cells, over a 3-day incubation period. The mucosal cells are damaged with a
 resultant inflammatory response similar to the common cold. During this time the virus is
 shed in nasal secretions causing disease in the lower respiratory tract, potentially causing
 fatal viral pneumonia.

 The literature supports that NO or its derivatives have inhibitory effects on a variety of
 viral infections. This inhibitory effect was shown to be marked in Interferon (IFN) mediated
 inhibition manifested by activated macrophage. It was also shown to be correlated with
 s-nitrosylation of viral proteins such as reductases and proteases.

 Based on the genetic similarities between SARS and corona viruses, similar viricidal effects
 of NO on COVID-19 can be hypothesized.

 SaNOtize has developed an innovative approach to provide nitric oxide gas using a formulation
 called Nitric Oxide Releasing Solution (NORS). This patented solution releases virucidal
 doses of NO for a sustained period and is effective at rapidly inactivating Influenza A and
 SARS-CoV-2.

 NORS delivered as a gargle (AM), nasal spray (PRN) or as a nasopharyngeal flush (PM) has the
 potential to decontaminate the upper respiratory tract that could preventing transmission and
 progression of COVID-19 in Healthcare Workers & Individuals at Risk of Infection.

 The randomized Prevention study will investigate the ability of NORS to prevent COVID-19
 infection when used prophylactically. The open-label Treatment Sub-Study is expected to be
 small and will provide pilot data on the possibility of NORS as a treatment for Mild/Moderate
 COVID-19 infection.
Prevention Study Inclusion Criteria:

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

 2. Men and Women ≥ 19 years of age unless local laws dictate otherwise;

 3. English speaking;

 4. Must be willing to use an adequate form of contraception (or abstinence) from the time
 of the first dose with the IMP until after the last dose of IMP.

 5. Be symptom-free at screening/baseline.

 6. Work/live in contact with COVID-19 infected patients or scheduled to work in a setting
 with high likelihood of contact with COVID-19 infected patients.

 Prevention Study Exclusion Criteria:

 1. Prior Tracheostomy;

 2. Concomitant treatment of respiratory support (involving any form of oxygen therapy);

 3. Any clinical contraindications, as judged by the attending physician;

 4. Any symptoms consistent with COVID-19;

 5. Pregnant;

 6. Mentally or neurologically disabled patients who are considered not fit to consent to
 their participation in the study;

 7. Prior COVID-19 infection.

 Treatment Sub study Inclusion Criteria:

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

 2. Men and Women ≥ 19 years of age unless local laws dictate otherwise;

 3. English speaking;

 4. Must be willing to use an adequate form of contraception (or abstinence) from the time
 of the first dose with the IMP until after the last dose of IMP;

 5. Positive COVID-19 test or presentation of clinical symptoms defined as fatigue with
 either fever >37.2 (oral) and/or a persistent cough.

 Treatment Sub Study Exclusion Criteria:

 1. Prior Tracheostomy;

 2. Concomitant treatment of respiratory support (involving any form of oxygen therapy);
 Any clinical contraindications, as judged by the attending physician;

 3. Mentally or neurologically disabled patients who are considered not fit to consent to
 their participation in the study;

 4. Pregnant;

 5. Currently hospitalized for symptoms of COVID-19.