For the treatment of COVID-19, standard maintenance therapy, corticosteroids, intravenous immunoglobulin, and antiviral drugs are used: remdesivir, ribavirin, lopinavir-ritonavir, umifenovir, interferons.

Interferon-alpha (IFN-alpha) elicits a response from both innate and acquired immunity. Clinical experience has shown that IFN-alpha effectively treats the previous SARS-CoV and MERS-CoV coronaviruses. The Chinese National Health Commission recommends using an inhaled form of interferon-alpha to treat SARS-CoV-2 pneumonia.

Recombinant interferon super-compound (rSIFN-co) is a new genetically engineered type I interferon. This interferon has a change in the spatial configuration of the protein, which led to a 20-fold increase in antiviral activity (including against SARS-CoV), a decrease in toxicity and side effects. rSIFN-co can be used safely in high doses, and each dose can be >10 million international units. That makes it possible to treat certain viral diseases or tumors requiring large interferon doses.

Chinese scientists have compared the efficacy and safety of rSIFN-co and traditional interferon-alpha for treating adult patients with moderate to severe COVID-19.

Study Participants and Drugs

The study involved 94 patients with moderate to severe COVID-19 hospitalized in five hospitals in Wuhan. The average age of patients is 54 years. The patients were divided into two groups:

  • 46 patients received inhaled rSIFN-co (12 IU, twice daily);
  • 48 patients received inhaled interferon-alpha (interferon-alpha-2a or interferon-alpha-2b, 5 million IU, twice daily).

The duration of receiving interferon is from distribution to the group until discharge from the hospital, but no more than 28 days. The median time from symptom onset to grouping was 14 days in the rSIFN-co group and 14.5 days in the interferon-alpha group.

In addition to interferon, patients received essential antiviral drugs: lopinavir-ritonavir or umifenovir.

The scientists estimated the time to clinical improvement, radiological improvement, the time to two consecutive negative PCR tests for SARS-CoV-2, and the overall rate of clinical improvement. Evaluating the safety, the scientists recorded adverse events resulting from the treatment.

Research Results

Efficiency

  • Time to clinical improvement in the rSIFN-co group was shorter than in the interferon-alpha group (11.5 days versus 14).
  • The overall rate of clinical improvement on day 28 was much higher in the rSIFN-co group than in the interferon-alpha group (93.5% vs 77.1%).
  • The time to radiological improvement in the rSIFN-co group was significantly shorter than in the interferon-alpha group (8 days versus 10).
  • The time to two consecutive negative PCR tests for SARS-CoV-2 in the rSIFN-co group was significantly shorter than in the interferon-alpha group (7 days versus 10).
  • Overall rates of radiological improvement on chest CT at 7 and 28 days were higher in the rSIFN-co group than in the interferon-alpha group, but a significant difference was observed only at 14 days (84.8% versus 66.7 %).
  • On day 28, the rSIFN-co group had significantly more negative PCR tests for SARS-CoV-2 than the interferon-alpha group (97.8% versus 85.4%).

Safety

Adverse events have been reported:

  • in 13 (28.3%) of 46 patients in the rSIFN-co group;
  • in 18 (38.5%) of 48 patients in the interferon-alpha group.

The most common adverse event in both groups is decreased appetite.

Severe adverse events:

  • in the rSIFN-co group – were not registered;
  • in the interferon-alpha group – one patient had a secondary bacterial infection followed by respiratory failure. The case was found to be unrelated to treatment.

There were no deaths in any group within 28 days of starting the medication.

Conclusions

In combination with antivirals, inhaled rSIFN-co significantly accelerated recovery in moderately severe COVID-19 patients compared to interferon-alpha. As part of COVID-19 complex therapy, rSIFN-co may be more effective than traditional interferon-alpha.

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Reference

Effect of a genetically engineered interferon-alpha versus traditional interferon-alpha in the treatment of moderate-to-severe COVID-19: a randomized clinical trial

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