Assessment of a cellular host response test to risk-stratify suspected COVID-19 patients in the Emergency Department setting

PLoS One. 2022 Mar 16;17(3):e0264220. doi: 10.1371/journal.pone.0264220. eCollection 2022.

Abstract

Objective: Assess the IntelliSep Index (ISI) for risk stratification of patients presenting to the Emergency Department (ED) with respiratory symptoms suspected of COVID-19 during the pandemic.

Methods: An observational single-center study of prospective cohort of patients presenting to the ED during the early COVID-19 pandemic with respiratory symptoms and a CBC drawn within 4.5 hours of initial vital signs. A sample of this blood was aliquoted for performance of the ISI, and patients were followed for clinical outcomes. The study required no patient-centered activity beyond standard of care and treating clinicians were unaware of study enrollment and ISI test results.

Main findings: 282 patients were included. The ISI ranges 0.1 to 10.0, with three interpretation bands indicating risk of adverse outcome: low (green), 0.1-4.9; intermediate (yellow), 5.0-6.2; and high (red), 6.3-10.0. Of 193 (68.4%) tested for SARS-CoV-2, 96 (49.7%) were positive. The ISI resulted in 182 (64.5%) green, 54 (18.1%) yellow, and 46 (15.6%) red band patients. Green band patients had a 1.1% (n = 2) 3-day mortality, while yellow and red band had 3.7% (n = 2, p > .05) and 10.9% (n = 5, p < .05) 3-day mortalities, respectively. Fewer green band patients required admission (96 [52.7%]) vs yellow (44 [81.5%]) and red (43 [93.5%]). Green band patients had more hospital free days (median 23 (Q1-Q3 20-25) than yellow (median 22 [Q1-Q3 0-23], p < 0.05) and red (median 21 [Q1-Q3 0-24], p < 0.01). SOFA increased with interpretation band: green (2, [Q1-Q3 0-4]) vs yellow (4, [Q1-Q3 2-5], p < 0.001) and red (5, [Q1-Q3 3-6]) p < 0.001).

Conclusions: The ISI rapidly risk-stratifies patients presenting to the ED during the early COVID-19 pandemic with signs or suspicion of respiratory infection.

Publication types

  • Clinical Trial
  • Observational Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 / mortality
  • Emergency Service, Hospital
  • Female
  • Humans
  • Immunity, Cellular
  • Male
  • Middle Aged
  • Mortality
  • Prospective Studies
  • Respiratory Tract Infections / etiology*
  • Respiratory Tract Infections / immunology
  • Respiratory Tract Infections / mortality

Grants and funding

Cytovale, Inc. funded this research, in part through Federal funds from part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00072. Several authors (RS, HTKT, and AMS) are employees of Cytovale and played a role in the design, analysis, interpretation, writing and decision to publish this study. Patient consent and medical direction for the study was conducted independently at the study facilities under the direction of Drs. Caffery, Thomas, and O’Neal, who have no financial interest in Cytovale.