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Disclosures: O’Neal reports research support from Cytovale Inc. Shah is the co-founder and CEO of Cytovale Inc.
April 30, 2020
2 min read

BARDA, Cytovale launch study to diagnose sepsis in patients with COVID-19

Disclosures: O’Neal reports research support from Cytovale Inc. Shah is the co-founder and CEO of Cytovale Inc.
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Hollis O’Neal
Ajay Shah

Cytovale Inc. will expand its partnership with the Biomedical Advanced Research and Development Authority, or BARDA, to examine the use of Cytovale’s Rapid Sepsis Diagnostic System for diagnosing sepsis in patients with potential respiratory infections, including COVID-19, according to a press release.

The study’s primary goal is to determine if the Rapid Sepsis Diagnostic System can identify the condition “quickly and accurately” in patients in the ED who may have COVID-19. It is being conducted at Our Lady of the Lake Regional Medical Center in Baton Rouge, LA, in partnership with Louisiana State University. Louisiana has emerged “as a COVID-19 hot spot,” according to Hollis O’Neal, MD, pulmonology critical care expert at Our Lady of the Lake, and primary investigator on the study.

“Patients with COVID-19 are at high risk for sepsis, a fast-moving and potentially deadly response to infection among critically ill patients,” O’Neal told Healio. “Sepsis is the result of an extreme response to infection that can lead quickly to organ failure and death and is key source of mortality in patients with COVID-19. Louisiana has emerged as a COVID-19 hot spot, which added urgency to the need for information. This urgency is compounded by a critical shortage of resources, including personal protective equipment (PPE), inpatient beds and diagnostic tests.”

Sepsis causes around 270,000 deaths in the United States annually. Cytovale’s diagnostic system can potentially diagnose sepsis in less than 10 minutes, with the potential to enable accurate and rapid triage in the ED.

“Early detection and triage of patients with sepsis has been a concern of critical care health care providers for a long time,” O’Neal said. “While we typically suspect a bacterial pathogen triggering sepsis in patients coming from the community, with COVID-19, we have seen that the body’s immune response to an underlying viral infection can result in sepsis as well.”

The partnership between BARDA and Cytovale was first announced in October 2019, with BARDA contributing $3.83 million of the estimated $5.9 million total cost of research. Cytovale will fund the remaining amount for the pilot study in COVID-19.

“COVID-19 has also brought the issue of resource preservation to the forefront.,” Ajay Shah, PhD, co-founder and CEO of Cytovale, told Healio. “We are optimistic that our technology can be a part of the solution by helping providers make informed decisions quickly to treat patients with sepsis who need it, spare those who don’t and ultimately help save lives.”– by Eamon Dreisbach

Disclosure: O’Neal reports research support from Cytovale Inc. Shah is the co-founder and CEO of Cytovale Inc.