The researchers who developed an interferon nebulizer for coronavirus patients have published promising results for a Phase 2 trial.
The Synairgen SNG001 nebulizer helped hospitalized patients recover from COVID-19 faster than a group who received a placebo.
A series of studies have shown that interferon may hold the key to preventing some COVID-19 deaths, as patients might suffer from unknown preexisting interferon-related conditions that could hinder COVID-19 recovery.
When a pathogen like the novel coronavirus starts infecting cells, it also temporarily disables the interferons that could deliver the host’s first immune response. Eventually, the immune system manages to beat the virus, and most people survive COVID-19. But a series of recent studies have revealed that people who might suffer from medical issues impacting interferon are more likely to develop severe complications that can lead to death.
Researchers showed that some people develop autoantibodies to interferon or suffer from genetic disorders that impact interferons. These medical issues might not be apparent in other illnesses, but they seem to impact COVID-19 patients. Screening for these problems might help doctors save more lives. Doctors may also adapt interferon-based therapies to treat COVID-19 patients. One such treatment is an interferon nebulizer that showed promise in an initial trial run earlier this year. The researchers have advanced to Phase 2 and say that inhaling interferon beta-1a instead of receiving it intravenously can significantly improve recovery.
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The researchers used the Synairgen SNG001 drug in a randomized, double-blind, placebo-controlled study in the UK. More than 100 COVID-19 patients were initially randomly assigned to the interferon drug or the placebo, and ultimately 48 of them got SNG001 and 50 received placebo.
“The primary outcome was the change in clinical condition on the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period in the intention-to-treat population (all randomized patients who received at least one dose of the study drug),” the scientists explain. “The OSCI is a 9-point scale, where 0 corresponds to no infection, and 8 corresponds to death.”
The scientists say that 66 patients required oxygen supplementation therapy in the hospital, and “patients receiving SNG001 had greater odds of improvement on the OSCI scale on day 15 or 16 and were more likely than those receiving placebo to recover to an OSCI score of 1 (no limitation of activities) during treatment.”
“The results of this pilot trial have shown that SNG001, given as a daily inhaled dose of 6 MIU via nebulizer for 14 days, was associated with greater odds of improvement versus placebo on the WHO OSCI and more rapid recovery to a point where patients were no longer limited in their activity, with a greater proportion of patients recovering during the 28-day study period,” the researchers concluded.
“The odds of recovery on day 28 were more than three-fold greater in the SNG001 group than in the placebo group,” they said.
A secondary outcome revealed an improvement in breathlessness and total and the Breathlessness, Cough, and Sputum Scale (BCSS) score during the treatment period with SNG001 than with placebo.
As for the drug’s safety, the study says the most frequently reported side effect was headache. None of the patients in the SNG001 group died, with the placebo group registering three deaths. But the drug has yet to show that it can prevent COVID-19 deaths. The researchers found “no significant difference between treatment groups in the odds of intubation or the time to intubation or death.”
“The findings of this trial suggest the potential utility of SNG001 in treating patients admitted to hospital with COVID-19, although SNG001 should be explored further in a phase 3 trial,” the researchers write. The researchers also note there may be advantages to delivering interferon directly to patients’ lungs than using it intravenously, as was the case in the massive Solidarity study that the WHO ran. That study showed that injected interferon is ineffective.
The researchers also note that more trials in different settings are needed, including in patients who are ventilated mechanically and in patients with mild to moderate COVID-19 not requiring treatment in the hospital. The study says that future trials could extend the patient follow-up beyond 28 days to determine the possible impact of interferon therapy on “the long-term sequelae of severe COVID-19.”