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.
Drug: NORS (Nitric Oxide Releasing Solution)
NORS treatment will consist of daily self-administration of three routes; Nitric Oxide Gargle (NOG) every morning, Nitric Oxide Nasophyaryngeal Irrigation (NONI) every evening, and Nitric Oxide Nasal Spray (NONS) up to 5 times per day.
Other Name: NOG, NONI, NONS
Drug: NORS (Nitric Oxide Releasing Solution)
Up to ten volunteers who are found to be COVID-19 positive during screening will be eligible to enroll in the 21-day Treatment sub-study and receive daily NORS treatment for 14 days. NORS treatment will consist of daily self-administration of three routes; Nitric Oxide Gargle (NOG) every morning, Nitric Oxide Nasophyaryngeal Irrigation (NONI) every evening, and Nitric Oxide Nasal Spray (NONS) up to 5 times per day.
Any participants enrolled in the Prevention study who meet the criteria for the sub study will roll over into the Treatment Sub-Study but must remain in their randomly assigned group.
Other Name: NOG, NONI, NONS
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.
BC Diabetes
Vancouver, British Columbia, Canada
LMC Manna
Pointe-Claire, Quebec, Canada
Diex Recherche Québec
Québec, Quebec, Canada
Diex Recherche Joliette
Saint-Charles-Borromée, Quebec, Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec, Canada
Jeremy Road, MD, Principal Investigator
Private Practice