REMAP-CAP is an adaptive trial and results are monitored on an ongoing basis. A Statistical Analysis Committee (SAC) regularly evaluates the trial data to determine whether a pre-specified threshold for statistical significance or statistical trigger is reached. If a statistical trigger has occurred, it is communicated immediately to the trial Data Safety and Monitoring Board (DSMB).
The DSMB is responsible for determining whether a statistical trigger should lead to conclusion of a trial arm. The DSMB is also responsible for ensuring treatments that are clearly ineffective will be discontinued promptly. The DSMB have not yet reported any statistical triggers or safety concerns for vitamin C in REMAP-CAP and the Principle Investigators of REMAP-CAP and Department are blinded from SAC evaluations.
Conclusion will be dependent on recruitment to REMAP-CAP and the strength of any therapeutic effect of vitamin C.