Hospitalizations due to coronavirus disease 2019 (COVID-19) persist despite available vaccines. In the phase 3 SPRINTER study, researchers evaluated the safety and efficacy of SNG001, a recombinant interferon (IFN)-β formulation delivered via nebulizer, in hospitalized patients with COVID-19 who required oxygen.
In the study, published in ERJ Open Research, there was no evidence that SNG001 improved times to hospital discharge or to no limitations on activities; however, the lead author, Phillip Monk, noted that SNG001 had a favorable safety profile, and secondary end point findings suggested SNG001 may have prevented progression to severe COVID-19.
Nebulized COVID-19 Treatment May Prevent Severe Disease
The study enrolled 309 patients to SNG001 and 314 to placebo once daily alongside standard of care. The primary end point of the trial was recovery after receiving SNG001 or placebo, and key secondary end points included progression to severe disease or death, progression to intubation or death, and overall mortality.
According to the report, the median time to hospital discharge was 7.0 days with SNG001 and 8.0 days with placebo (hazard ratio [HR], 1.06; 95% CI, 0.89-1.27; P=.51). Both groups had a recovery time to no limitation of activities of 25.0 days (HR, 1.02; 95% CI, 0.81-1.28; P=.89). Serious adverse events occurred in 12.6% of patients in the SNG001 group compared with 18.2% of those in the placebo group.
In addition, researchers found no significant differences between SNG001 and placebo for key secondary endpoints, with rates of progression to severe disease or death of 10.7% and 14.4%, respectively, representing a 25.7% relative risk reduction (odds ratio, 0.71; 95% CI, 0.44-1.15; P=.161).
“When combined with the results of the previous phase II study,” the authors summarized, “these findings provide a rationale to continue investigating SNG001, not only in hospitalised patients with COVID-19… but also more widely in patients with severe seasonal viral lung infections, due to the broad spectrum and variant agnostic antiviral activity of IFN-β.”