The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.

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As winter approaches, the numbers of COVID-19 cases, positive COVID-19 tests, and COVID-19–related hospitalizations appear to be increasing. Because many Americans are now testing at home, the National Institutes of Health (NIH) have launched the MakeMyTestCount website, which enables people with internet access to report their at-home test results.

Paxlovid has been shown to decrease hospitalization rates for adults. A recent Centers for Disease Control and Prevention (CDC) investigation of electronic health records (EHR) of 699,848 adults aged 18 years and older who were eligible for Paxlovid during April–August 2022, found that only 28.4 percent of eligible patients received a Paxlovid prescription within 5 days of COVID-19 diagnosis. Those who took Paxlovid within 5 days of diagnosis had a 51 percent lower rate of hospitalization than those who did not. Hesitency around taking the drug seems to stem from concerns regarding treatment side effects and viral rebound.

Preventing hospitalizations is especially important while flu cases and hospitalizations are rising, and emerging SARS-CoV-2 variants appear to be outpacing treatments for severe COVID-19. Most recently, the Emergency Use Authorization (EUA) for the antibody bebtelovimab was revoked because the drug does not neutralize Omicron subvariants BQ.1 and BQ1.1, which are currently dominant in the US. See Topics to Watch for 2 emerging treatments for hospitalized patients.

Subcutaneous Anakinra (Kineret) to Treat Hospitalized COVID-19 Patients with Pneumonia at Risk of Progressing to Severe Respiratory Failure

At a Glance

  • The clinical course of SARS-CoV-2 infection can be unpredictable. Detecting early biomarkers of severe disease might aid in management and improve patient health outcomes. Urokinase plasminogen activator receptor (uPAR) is a protein expressed by activated immune cells. Early detection of elevated levels of soluble urokinase plasminogen activator receptor (suPAR) in blood might effectively predict progression to severe COVID-19.
  • Anakinra (Kineret) is an immunosuppressive drug that blocks the activity of cytokines IL-1α and β and is being developed as a treatment for patients hospitalized with COVID-19 pneumonia who are at risk of progressing to severe respiratory failure.
  • A recent phase 3 study reported that early, suPAR-guided anakinra plus standard-of-care treatment reduced 28-day mortality, progression to severe respiratory failure by 3-fold, and the average time until intensive care unit discharge by 4 days.
  • Based on these results, in November 2022, the FDA granted anakinra Emergency Use Authorization (EUA) for this indication.
  • A 10-day course of anakinra, given as a 100-mg once-daily injection under the skin, might cost about $1,810.

Vilobelimab (IFX-1) to Treat Severe COVID-19 Pneumonia

At a Glance

  • Severe COVID-19 pneumonia is associated with poor overall outcomes and high mortality rate (40%) in hospitalized, mechanically ventilated patients. A significant unmet need remains for effective treatments.
  • The complement system enhances the immune system’s ability to fight bacterial and viral infection. In some diseases, possibly including COVID-19, dysregulation of the complement system can instead contribute to disease pathology.
  • Vilobelimab is a monoclonal antibody which inhibits complement factor C5a. It is designed to dampen the runaway, damaging immune response, but preserve the ability to respond to and eliminate pathogens.
  • Results published in September 2022 indicate that vilobelimab was well tolerated and decreased overall mortality by 10% in patients hospitalized with COVID-19–related severe pneumonia and who were mechanically ventilated. The developer has applied for EUA based on these data.

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Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.

We welcome your comments on this Scan. Send them by email to [email protected].

Posted: December 19, 2022

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