Summary of COVID-19 CK0802 studies
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RCT 45 critically ill COVID-19 ARDS patients showing no significant difference with allogeneic cord blood T-regulatory cells (Tregs). Patients were randomized to receive placebo, 100 million Tregs, or 300 million Tregs with three infusions over 7 days. While the 100 million cell dose group showed a higher probability of survival (not meeting the 99% threshold for significance), the 300 million cell group showed no benefit. Authors note that this may be due to baseline imbalances in the high-dose group.
Jun 2023, Blood Advances, https://ashpublications.org/bloodadvances/article/7/13/3075/495068/Randomized-double-blinded-placebo-controlled-trial, https://c19p.org/gladstone
1. Gladstone et al., Randomized, double-blinded, placebo-controlled trial of allogeneic cord blood T-regulatory cells for treatment of COVID-19 ARDS
30 patient CK0802 late treatment RCT: 8% higher mortality (p=0.91) and 27% higher combined mortality/intubation (p=0.42).RCT 45 critically ill COVID-19 ARDS patients showing no significant difference with allogeneic cord blood T-regulatory cells (Tregs). Patients were randomized to receive placebo, 100 million Tregs, or 300 million Tregs with three infusions over 7 days. While the 100 million cell dose group showed a higher probability of survival (not meeting the 99% threshold for significance), the 300 million cell group showed no benefit. Authors note that this may be due to baseline imbalances in the high-dose group.
Jun 2023, Blood Advances, https://ashpublications.org/bloodadvances/article/7/13/3075/495068/Randomized-double-blinded-placebo-controlled-trial, https://c19p.org/gladstone
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