STOP-ARDS Clinical Trial
Steroid Therapy Optimization for Prevention of Acute Respiratory Distress Syndrome
Steroid Therapy Optimization for Prevention of Acute Respiratory Distress Syndrome (STOP-ARDS) is a randomized controlled trial evaluating hydrocortisone therapy in patients with Severe Acute Respiratory Infection (SARI) to prevent progression to Acute Respiratory Distress Syndrome (ARDS).
The trial uses Prenosis’ FDA Breakthrough Device-designated steroids companion diagnostic to test whether the algorithm can identify which patients hospitalized with SARI would either benefit from or be harmed by hydrocortisone treatment.
STOP-ARDS follows a prospective-retrospective design, evaluating the steroids companion diagnostic’s classification of patients as steroid-responsive (SR+) or non-responsive (SR−) against pre-specified performance criteria. The algorithm is not used to guide treatment or randomization decisions during the trial itself.
If the STOP-ARDS clinical trial demonstrates that the algorithm accurately identifies hydrocortisone responders, it will be locked for a future pivotal study assessing whether SR+ patients experience a significant reduction in ARDS compared with SR− patients.
STOP-ARDS is funded through Prenosis’ $20 million BARDA contract, awarded to advance a precision medicine platform for preventing and treating ARDS.