In the current pandemic, ICUs worldwide are caring for COVID-19 patients with life-threatening multiple organ dysfunction, in other words, sepsis. This trend provides a stark reminder that sepsis is likely to arise as a secondary confounder of any health security threat, whether in the current coronavirus pandemic or a future public health emergency.
BARDA focuses on developing safe, effective medical countermeasures, such as vaccines, treatments, and diagnostics, against all potential health security threats the United States faces – chemical, biological, radiological, nuclear, pandemic, and emerging infectious diseases. Being fully prepared for those threats requires real solutions for sepsis.
In 2018, BARDA launched the DRIVe Solving Sepsis program to expand the range of tools to reduce the incidence, morbidity, mortality, and cost of sepsis, and to prepare for health security threats. Sepsis, a term still unfamiliar to many Americans, is a dysregulated response to infection leading to organ dysfunction.
Any infection can lead to sepsis – a bacterial infection, seasonal influenza, or SARS-CoV-2. Sepsis is far reaching, affecting individuals of any age from neonates to the elderly, and can be life threatening. The CDC reports more than 270,000 lives are lost to sepsis each year in the U.S., among more than 1.7 million cases. In years with major public health events, like COVID-19 that can lead to viral sepsis, those numbers can climb much higher.
Diagnostics for SARS-CoV-2 infection are critical to the response, but they don’t tell the whole story. Roughly 20 percent of those infected become severely ill and require hospitalization. There’s a need to identify COVID-19 patients who are on the path to sepsis. BARDA is exploring whether technologies that may predict sepsis can aid healthcare providers and COVID-19 patients in early identification of health deterioration before patients fall victim to sepsis. If providers could identify those patients sooner, both in hospitals and remotely in other care settings, those professionals could make informed, strategic decisions about the critical resources needed and better target early interventions to improve patient outcomes.
Pilot studies launched through the Rapidly Deployable Capabilities team, as part of the BARDA-COVID-19 medical countermeasure response, will evaluate utility of these technologies for COVID-19 patients and potentially against any future public health threat to our nation. Since the sepsis technologies are agnostic to the source of infection, validating their use builds real solutions to any emerging infectious disease outbreak.
BARDA partnered with Cytovale and Immunexpress; both are developing diagnostic devices for rapid assessment of blood biomarkers that identify or predict the onset of sepsis. These host-blood-based technologies are being evaluated for their ability to detect sepsis earlier in COVID-19 patients. The rapid turnaround and minimal blood volume needed could provide results indicating sepsis in COVID-19 patients in tandem or faster than molecular SARS-CoV-2 confirmation results.
BARDA also extended our partnership with Beckman Coulter for the COVID-19 response. Beckman Coulter is working with Dascena to develop a machine learning algorithm to predict using their Early Sepsis Indicator results combined with clinical and vital sign data from the Electronic Health Record to determine the likelihood of sepsis prior to the onset of clinical symptoms. These sepsis diagnostic tools identify the risk of severe patient outcomes, providing critical information for clinical management and allocation of precious hospital resources.
In parallel, we are working with the Sepsis Alliance to broaden training and education for healthcare providers to draw the connection between emerging infectious disease, like COVID-19, and sepsis and the need to monitor the long-term health of COVID-19 sepsis survivors.