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 Centers for Disease Control and Prevention (CDC) has officially launched a new forecasting center for infectious diseases. The Center for Forecasting and Outbreak Analytics (CFA) intends to improve outbreak predictions through a combination of its own work and the funding of work by public, private, and academic partners. The Center claims early success with Omicron predictions, but it remains to be seen if a robust early warning system for infectious diseases can be brought to fruition.

A recently updated treatment guideline from the World Health Organization (WHO) gives a strong recommendation for Paxlovid (nirmatrelvir and ritonavir) to treat mild COVID-19, yet little has changed regarding recommended treatments for severe to critical COVID-19. This week’s Topics to Watch examines the potential of a new stem cell treatment, plus an innovative breath test that could be useful if screening in crowded indoor spaces once again becomes important following the removal of most mask mandates.

ExoFlo to Treat Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19

At a Glance

  • ExoFlo is a biologic being investigated to treat adults with moderate to severe acute respiratory distress syndrome (ARDS) associated with COVID-19.
  • The treatment is an extracellular signaling product consisting of extracellular vesicles (cellular structures used to communicate with other cells) and growth factors isolated from mesenchymal stromal/stem cells (MSCs). It is intended to reduce inflammation and lung injury associated with ARDs and promote tissue healing.
  • Results from a phase 2 trial in 120 adults with moderate to severe ARDS suggested that ExoFlo was associated with a reduction in mortality at 60 days compared with placebo, as well as decreased time to hospital discharge and increased ventilator-free days.
  • The FDA granted ExoFlo Regenerative Medicine Advanced Therapy (RMAT) designation, and has greenlighted its further investigation in phase 3 trials.

InspectIR COVID-19 Breathalyzer to Detect SARS-CoV-2 Infection

At a Glance

  • The InspectIR COVID-19 Breathalyzer is a portable testing device intended to rapidly detect and identify certain markers of SARS-CoV-2 infection in exhaled breath using a method called gas chromatography-mass spectrometry.
  • In a study of 2409 symptomatic and asymptomatic individuals, the device correctly identified 91.2% of positive samples and 99.3% of negative samples. However, the FDA cautions that positive results should be confirmed with a molecular test, and negative results do not conclusively rule out infection and should not be used as the sole basis for treatment or patient management decisions.
  • The testing device received Emergency Use Authorization (EUA) from the FDA in April 2022 for use in adults and is expected to be available clinically around July 2022. The test requires a prescription and the device is intended for use by a qualified, trained operator. Although the device’s cost has not been announced, each test might cost about $10 to $12.

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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: May 6, 2022

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