I-SPY COVID Trial Sponsored by Quantum Leap Healthcare Collaborative Reports Assessment of Narsoplimab for Treatment of Critically Ill Patients With COVID-19
Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, and Omeros Corporation (NASDAQ: OMER), developer of the investigational agent narsoplimab, announced that enrollment has been closed and data have been analyzed in the narsoplimab arm of the I-SPY COVID Trial. The analysis in the randomized patient population, including those who declined treatment after randomization, shows that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces mortality risk (hazard ratio [HR]=0.81 with probability [HR <1] equal to 0.77)
SAN FRANCISCO & SEATTLE--(BUSINESS WIRE)--Sep 15, 2022--
Quantum Leap Healthcare Collaborative (QLHC), sponsor of the I-SPY COVID Trial, and Omeros Corporation (NASDAQ: OMER), developer of the investigational agent narsoplimab, announced that enrollment has been closed and data have been analyzed in the narsoplimab arm of the I-SPY COVID Trial. The analysis in the randomized patient population, including those who declined treatment after randomization, shows that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces mortality risk (hazard ratio [HR]=0.81 with probability [HR <1] equal to 0.77).
Neither futility nor graduation criteria were met in the analysis of the randomized population at the time the narsoplimab arm was terminated.
There were 91 patients randomized to the narsoplimab arm of the trial across 27 participating US sites. The 91 randomized patients were compared to the 116 patients concurrently randomized to the control arm. All patients received standard of care including dexamethasone and remdesivir. Bayesian statistics were prespecified and employed for analyses.
