Updates on studies using Spinnaker Dec 2020
ASCOT ADAPT opened for enrolments in India this week. The trial will generate clinical evidence about treatment for COVID-19 that can be applied during the pandemic, to reduce mortality or the need for mechanical ventilation in hospitalised but not yet critically ill patients with COVID-19.
Mega-ROX began enrolling patients in May and has over 500 patients enrolled in New Zealand, Japan and Saudi Arabia. With a goal of enrolling over 40,000 patients, this is going to be a mammoth study. The trial is comparing conservative vs. liberal oxygenation targets in mechanically ventilated adults in intensive care.
PLUS has reached 5,000 enrolments and is closing at the end of the year. This trial is testing whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation, when compared to the same treatment with 0.9% sodium chloride (saline).
REMAP-CAP Covid-19 brought immense challenges to everyone in 2020, and it brought us our greatest challenge ever: adapting our Spinnaker platform to manage the world’s most complex clinical trial – a trial that tackled Covid-19 head-on. At the time of writing this the REMAP-CAP trial has over 3,500 patients enrolled, in over 15 countries, at 300 sites around the world.
SNAP is our latest study out of the gate and still in the early development stage. It’s a clinical trial for golden staph bloodstream infections. SNAP aims to improve treatment outcomes for patients with common, but deadly, golden staph bloodstream infections.
TTM2 has completed enrolments. 1,900 patients randomised – bra gjort! (That’s well done in Sweden, which is mission control for the study.) TTM2 is investigating whether targeted temperature management (TTM) to 33°C improves survival and neurological outcome at 6 months, compared to a strategy of targeting normothermia and avoiding fever above 37.7°C for cardiac patients admitted to intensive care.
TAME has enrolled over 1,200 patients, which is an epic achievement in the middle of a pandemic. TAME is also looking at cardiac patients admitted to intensive care, and investigating if targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN).
