Clinical Trial Confirms Nasal Spray Efficacy in Treating, Reducing Transmission of COVID-19

Results of clinical trials conducted in the United Kingdom have shown that a nitric oxide nasal spray (NONS, SaNOtize) is both a safe and effective antiviral treatment to prevent COVID-19 transmission and symptom duration, as well as reduce symptom severity and damage in those already infected, according to the study authors.

During the randomized, double-blind, placebo-controlled phase 2 trial, the investigators assessed 79 patients with confirmed COVID-19 who were given the spray early following diagnosis. The results following treatment demonstrated that the spray significantly reduced the level of SARS-CoV-2, even in patients with high viral loads, according to the study.

“NONS destroys the virus, blocks entry into and halts viral replication within the nasal cavity, which rapidly reduces viral load. This is significant because viral load has been linked to infectivity and poor outcomes,” said Chris Miller, PhD, RT, chief science officer and co-founder of SaNOtize, in a press release. “There is currently a lack of an antiviral therapy that is effective against COVID-19 and its variants, can prevent or shorten the course of the disease, reduce damage, lower the severity of COVID-19, and can be made widely and readily available to the public.”

In the first 24 hours following treatment with the spray, investigators observed that the average viral log reduction was 1.362, which is a decline of approximately 95%. After 72 hours following treatment, the viral load decreased by more than 99%.

Additionally, the majority of patients included in the study were found to be infected with the UK variant of SARS-CoV-2, which has been a variant of concern in terms of treatments. Following treatment with the nasal spray, patients had no adverse events during the UK trial, which corresponds with the results from earlier Canadian clinical trials that assessed results from more than 7000 self-administered treatments of the nasal spray by patients.

Currently, the spray is the only novel therapeutic treatment that has demonstrated a significant reduction in viral load in humans that is not a monoclonal antibody treatment. This is an asset because monoclonal antibody treatments are not only very specific, but also expensive and need intravenous administration in a clinical setting. The novel spray does not require in-clinic administration and can be self-administered by patients, while also being more affordable.

“I expect this to be a major advance in the global battle against the devastating human impacts of the COVID-19 pandemic,” said Stephen Winchester, MB BS, FRCPath, consultant medical virologist and chief investigator of the UK National Health Service Clinical Trial, in a press release. “This simple portable nasal spray could be highly effective in the treatment of COVID-19 and reducing onward transmission. Our trial included patients with a variant of concern and high viral loads yet still demonstrated significant reductions in the levels of SARS-CoV-2, which could be critical in supporting vaccines, preventing future outbreaks and safely reopening economies. Simply stated, I think this could be revolutionary.”

The spray works by killing the virus in the upper airways, which then prevents further spread to the lungs and incubation. The treatment uses nitric oxide (NO), which is a natural nanomolecule that can be produced by the human body. NO is a well-established anti-microbial that has demonstrated a clear impact on SARS-CoV-2.

Additionally, the pharmacology, toxicity, and safety data for NO use in humans has been known for decades, which has allowed it to be a safe treatment method for use in newborn babies as well as adults. Specifically, the NO molecule used in the novel spray is identical to the molecule that has been used to treat persistent pulmonary hypertension in newborn babies.

Following the release of the phase 2 clinical data from the UK, the earlier phase 2 Canadian trials, and independent lab tests conducted at the Antiviral Research Institute at Utah State University, SaNOtize is applying for emergency use authorization to regulatory authorities in the UK and Canada currently.

“The rigor of this trial and the decades of safety data behind nitric oxide gives us full confidence in requesting emergency use approval in the UK, Canada and elsewhere in the world.” said Rob Wilson, SaNOtize’s UK representative, in the press release. “We are pleased to have conducted this crucial trial in the NHS and now hope that regulators will play their part in arming the public in the battle against this devastating disease.”

REFERENCE

UK Clinical Trial Confirms SaNOtize’s Breakthrough Treatment for COVID-19. Surrey, UK: SaNOtize Research & Development Corp; March 15, 2021. https://www.businesswire.com/news/home/20210315005197/en. Accessed March 16, 2021.