Briefing

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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The work to develop a robust treatment for COVID-19 continues (see Topics to Watch). Recently, Merck and Ridgeback Biotherapeutics submitted an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for molnupiravir (for horizon scanning details, see PCORI Biweekly COVID-19 Scan: June 10-23, 2021). However, as some aspects of the pandemic continue, some are asking what comes next.

Predicting pandemics and their impacts has historically been a niche practice. However, many hope to leverage this predictive practice to a greater extent now that society has experienced the consequences of being unprepared. Recent discussions have examined how we might learn from pandemics of the past, acknowledge that present human activity will create spillover events in the future, and prepare for that future, possibly with pan-coronavirus vaccines.

A pair of solution scans have compiled the numerous societal and policy options that could give policymakers a head start to prevent animal diseases from crossing to humans and reduce the spread among people to lower the impact or prevent a pandemic when the next virus does spill over.

Lenzilumab to Treat Patients Hospitalized with COVID-19 Pneumonia

At a Glance

  • Lenzilumab is a monoclonal antibody that is under investigation to treat patients hospitalized with COVID-19 pneumonia.
  • Lenzilumab purportedly binds to and blocks the immune signaling ability of granulocyte-macrophage colony-stimulating factor (GM-CSF), preventing the cytokine storm associated with severe COVID-19 outcomes, including multi-organ failure and death.
  • Data released in October 2021 found that lenzilumab improved the likelihood of survival without the need for mechanical ventilation in hospitalized patients who had low oxygen levels. Lenzilumab is currently being compared with placebo in combination with remdesivir in a phase 3 trial with estimated completion in December 2021.
  • The FDA rejected the EUA for lenzilumab in September 2021, before the release of new data, but the FDA remains receptive to additional data as it becomes available.
  • A preliminary report suggested that before the EUA submission, the manufacturer announced plans to charge about $10 000 per treatment course. 

PUL-042 to Treat Mild to Moderate COVID-19

At a Glance

  • PUL-042 is an inhaled nebulized drug that comprises 2 synthetic toll-like receptor (TLR) agonists, TLR 2/6 and TLR 9, and is being investigated to treat adults with mild to moderate COVID-19.
  • Treatment with PUL-042 purportedly stimulates the body’s natural first-line immune responses (ie, innate immunity) to rapidly eliminate the SARS-CoV-2 virus and reduce the duration of respiratory symptoms.
  • Topline data reported from a phase 2 randomized controlled clinical trial in 101 adults with mild to moderate COVID-19 found that after the 6-day treatment period, the median time to the improvement of respiratory symptoms (eg, cough, shortness of breath) was 6 days for PUL-042, compared with 9 days for patients given placebo.
  • Pulmotect plans to submit an EUA to the FDA for PUL-042 in 2021.

Return to the Main Page Download this COVID-19 Scan

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]
or by mail to: Patient-Centered Outcomes Research Institute, 1828 L Street, NW, Suite 900, Washington, DC 20036.


Posted: October 26, 2021

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