Rapid Cytokine Measurement in Patients with COVID-19

This project is examining the use of a rapid microfluidic cytokine assay developed in the College of Engineering to determine feasibility and acceptability of returning cytokine levels to treating clinicians in patients with COVID-19. MIAP had a consultation with this team and provided protocol review and comments. We also consulted with the IRB. This study did not require FDA submission or approval, only IRB approval. This study is now IRB approved and enrolling subjects; (HUM00179668). Primary Objective: To provide clinicians with rapid information regarding cytokine levels in critically ill patients with COVID19. Secondary Objectives: To determine if rapid determination of cytokine levels contributes to medical decision making in critically ill patients with COVID19; To determine if cytokine levels correlate to other clinically used nonspecific markers of inflammation and organ injury. This trial is testing a flexible, microfluidic platform for multiplex, fast measurement of multiple cytokines from a small volume of serum. This platform has been compared to gold standard ELISA measurements in serum samples from patients with cytokine release syndrome, and is highly accurate though much faster than those assays, with a sample-to-answer time of 1-2 hours. In addition, this platform is much more robust at low analyte concentrations than standard ELISA, raising the possibility of detection of cytokine release earlier in disease than current methods. The study population is individuals hospitalized at Michigan Medicine with critical illness due to COVID19, and we will be recruiting directly from this population.

Primary Objective: To provide clinicians with rapid information regarding cytokine levels in critically ill patients with COVID19. Secondary Objectives: To determine if rapid determination of cytokine levels contributes to medical decision making in critically ill patients with COVID19; To determine if cytokine levels correlate to other clinically used nonspecific markers of inflammation and organ injury.
Target Population
The study population is individuals hospitalized at Michigan Medicine with critical illness due to COVID19, and we will be recruiting directly from this population.
Primary Investigator
Benjamin
Singer
Contact Email
Study Type
Clinicaltrials.gov Status
Submitted to clinicaltrials.gov
Current Study Status
Recruiting
Current Study Phase
Phase 1
Clinical Trial Network Utilization
Not Sure
Accrual Target Number
700
CTSA Support
Yes
Locations