NEW YORK (Reuters Health) – In patients with moderate-severe COVID-19, recombinant super-compound interferon (rSIFN-co) plus baseline antivirals was associated with a shorter time to clinical improvement than the same regimen using traditional interferon-alpha in an exploratory trial in China.

“Since no antiviral agents were confirmed to be effective for COVID-19 during our study period, there was a pressing need to develop new therapeutics,” Dr. Lunxu Liu of Sichuan University told Reuters Health by email. In response, he said, Chinese scientists created rSIFN-co, a novel genetically engineered interferon.

“Many studies have shown the early use of interferon helps not only in reducing viral replication but also in the activation and development of innate and adaptive antiviral immunity,” he noted. “Early use of rSIFN-co in COVID-19 patients…appeared to provide a possible treatment in the management of COVID-19.”

‘We believe that treatment with rSIFN-co may also have prevented progression to severe respiratory disease,” he added, “and can be beneficial in slowing the tide of COVID-19 pandemic by reducing the duration of viral shedding.”

As reported in Annals of Medicine, the multicenter study randomized 94 patients (median age, 54; about half women) to baseline antiviral agents plus nebulization with rSIFN-co or interferon-alpha for up to 28 days.

The time to clinical improvement was 11.5 days with rSIFN-co versus 14 days with standard interferon alpha. On day 28, the overall rate of clinical improvement was 93.5% versus 77.1%.

The time to radiological improvement was eight days versus 10 days, and the time to virus nucleic acid negative conversion was seven versus 10 days.

Adverse events were reported by 13 (28%) patients in the rSIFN-co group and 18 (38.5%) in the interferon-alpha group. Most events were classified as grade 1 or 2, with decreased appetite being the most common in both groups. No deaths occurred during the study.

Dr. Liu said, “We plan to conduct a large, international, multi-center prospective trial with rSIFN-co therapy alone or combined with other antiviral therapies that include a broader range of patients with COVID-19, if possible.”

Dr. Mamta Jain, a professor in the Infectious Disease Division at UT Southwestern Medical Center in Dallas, commented by email to Reuters Health. “This study is small and preliminary. It is a unique delivery system and may have fewer side effects than traditional interferon-alpha. However, we need larger studies to confirm clinical efficacy and safety.”

Dr. Carl Fichtenbaum, Associate Chairman of Medicine for Translational Research at the University of Cincinnati College of Medicine, told Reuters Health, “The study shows a minimal benefit to the re-engineered version of interferon alfa. If you look at 28 days, no difference,” he said by email. “So, it was really a minor difference at days seven and 14. If you look closely at the article, by the ‘ordinal scale’ that most researchers use, no difference was seen. No data was presented on virologic response.”

“We need a lot more data and proof before I would use this. And the lack of a control group that got just standard of care is a big weakness of this study.”

Dr. Scott Braunstein, Medical Director at Sollis Health in New York, Los Angeles and Miami also commented by email. “The primary outcome of the study – time to clinical improvement – did not reach statistical significance. This may simply be due to insufficient sample size, but could represent a lack of clinical difference between these two treatments. However, the patients in the standard interferon alpha group tended to be older (56 vs. 51 years old), and had more co-morbidities such as hypertension, diabetes and heart disease, which could have affected the results in favor of the engineered interferon.”

Like Dr. Fichtenbaum, he noted, “It would have been helpful to include a placebo arm, to show how much benefit there was to using even standard nebulized interferon alpha.”

SOURCE: https://bit.ly/2Pf1Mki Annals of Medicine, online February 23, 2021.

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