RE: BARDA selects novel therapeutic candidates to evaluate in platform clinical trial for acute respiratory distress syndrome treatment1 Jul 2024 21:11
Clearly SNG is nowhere near being a candidate for this. Miles off, but if you really want to guess the protocols and endpoints, lemme see if I can help
Inclusion criteria. Ventilated with ARDS. Primary endpoints...er........ Mortality ? Secondary... er.... more mortality & discharge from hospital.
Both drugs have already published small P2s for ARDS and they're probably 2-3 years ahead of SNG in this field ( clinical trials are difficult and take time - as we've all been reminded many times ) assuming someone comes up with the proof of concept stake money - and the eventual P2 data is close enough to these results.
Paridiprubart
Mortality at 28-days post-treatment was 7.7% (1/13) in the paridiprubart group versus 40.0% (8/20) for placebo (OR=0.125; 95% CI, 0.013-1.160; P=0.067; P[bootstrap]=0.011). 60-day mortality was 23.1% (3/13) in paridiprubart-treated patients and 45.0% (9/20) in placebo patients (OR=0.367; 95% CI, 0.077-1.749; P=0.208; P[bootstrap]=0.162). Mean survival time was 55.78 days for paridiprubart recipients compared to 41.44 days for placebo patients (HR=0.386; 95% CI, 0.077-1.436; P=0.156; P[bootstrap]=0.083).
Conclusions: In COVID-19 patients with ARDS requiring invasive ventilation and organ support,
paridiprubart was efficacious in preventing mortality and improving clinical outcomes, with no
safety concerns.
Vilobelimab
54 patients (31%) of 177 in the vilobelimab group and 77 patients (40%) of 191 in the placebo group died in the first 28 days. The all-cause mortality rate at 28 days was 32% (95% CI 25–39) in the vilobelimab group and 42% (35–49) in the placebo group (hazard ratio 0·73, 95% CI 0·50–1·06; p=0·094). In the predefined analysis without site-stratification, vilobelimab significantly reduced all-cause mortality at 28 days (HR 0·67, 95% CI 0·48–0·96; p=0·027).
Conclusions: In addition to standard of care, vilobelimab improves survival of invasive mechanically ventilated patients with COVID-19 and leads to a significant decrease in mortality. Vilobelimab could be considered as an additional therapy for patients in this setting