SPRINGFIELD, Mo. — Missouri State University (MSU) conducted a clinical trial with long COVID patients and found after using a nasal spray, patients felt better within minutes.
“When we had our first patient come into the clinical trial and she sprayed it up her nose and 15 minutes later we took her oxygen levels and they were up,” Associate Professor of Biology Dr. Christopher Lupfer said. “I was actually quite surprised. Seven days later we’re seeing an even more dramatic effect on blood oxygen levels.”
The clinical trial included 22 patients who had tested positive for COVID before, but were still having symptoms after they recovered. The patients ranged from 18 to 40 years old.
“This trial was designed for a seven day period,” Lupfer said. “So we monitored the patients for seven days with no treatment whatsoever and then seven days on the treatment.”
The treatment was a nasal spray called N115. Participants sprayed N115 three times in each nostril for three times a day.
“The N115 nasal spray is actually used in a lot of research media and things that we grow cells in,” Lupfer said. “We realized that we were having differences in the immune response during our infection and we were able to track it down to the fact that certain manufacturers include pyruvate and others don’t, and that’s originally how we discovered that pyruvate has this kind of anti-inflammatory effect.”
N115 has also helped patients with various respiratory diseases.
“What we did is we have the world patents for [N115] use as a nasal spray or inhalation for the treatment of COPD and all respiratory diseases,” CEO of Emphycorp Dr. Alain Martin said. “So in short we have been working at this for 20 years.”
Emphycorp collaborated with MSU to conduct the trial.
“N115 is a natural compound called sodium pyruvate that’s found in every cell in your body, and it’s a natural antioxidant and it’s been approved by the FDA for storage of red blood cells,” Martin said. “The reason we got into COVID and long COVID was we showed in our clinical trials that inhalation of N115 or sodium pyruvate reduces viral titers down to 6.4 days versus 10.4 for untreated, which means the ability to contaminate somebody goes down.”
Once participants used the spray, they saw improvement in all of their symptoms – like headaches, coughing, and breathing. Doctors also saw an increase in blood oxygen levels.
“It has some anti-inflammatory effects,” Lupfer said. “Any kind of residual or leftover inflammation, it helps with decreasing that. It also increases nitric oxide and nitric oxide actually affects the bronchodilation, so that’s the airways in your lungs. It helps them dilate so you can get more air into your lungs.”
Lupfer said he is not sure if patients have to continue to use N115 for relief of symptoms. He’s hopeful it will be on the market soon.
“So the FDA will have to assess that they would look at the safety and the efficacy and determine whether it could be an over the counter or whether it would need to be a prescription medication,” Lupfer said.
Martin said the FDA has asked Emphycorp to fill out a new drug application for N115 regarding treatment for pulmonary fibrosis. If approved, Martin said this would be a step towards helping long COVID patients.
“Long haulers, 20 million of them about 10% to 15%, two million develop pulmonary fibrosis and we have a FDA approved treatment,” Martin said.
Martin said it is up in the air whether N115 would be an over the counter or prescription medication. Once it gets approved, the next step is getting it out to drug stores.
“The biggest problem in the U.S. is the logistics of you have to be registered in 50 states,” Martin said. “You have to be able to get it to 67,000 pharmacies when you file a new drug application. All the large companies that could do what we need to do are getting federal money for COVID. So you know, think about it. From their point, you get $2 billion to develop something, and it’s free. Why you gonna bother with us?”
Martin said the positive impact is worth every penny.
“This is something that can help a lot of people at a reasonable price,” Martin said. “It’s safe and efficacious.”
It is unclear if N115 could help relieve symptoms of the common cold or flu. MSU is hoping to find that answer.
“We actually have another clinical trial that’s ongoing to study how effective it would be for flu,” Lupfer said. “We would hope to see a few patients this winter with flu so that we can start to assess whether it would be useful during a flu infection or not.”