TBIDT, APT-TBI-01, Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury

ABSTRACT Multi-Arm Multi-Stage Adaptive Platform Trial (APT) for the Acute Treatment of Traumatic Brain Injury Multi-center, double-blind, placebo-controlled, adaptive platform, precision medicine trial conducted under a single multi-arm, multi-stage (MAMS) study with parallel groups. Participants will be randomized to receive one of four possible treatment interventions: Atorvastatin calcium (ATOR) Minocycline hydrochloride (MINO) Candesartan cilexetil (CAND) Matching Placebo The study requirements consist of an eligibility surveillance, consenting, randomization, intervention, and follow-up phase, in that order. Participants shall receive all necessary standard of care while only receiving mITT (modified intent to treat) after signing (or LAR signing of) their respective consent form. The standard of care for a participant who has had a TBI is state and site specific, but may consist of a CT scan, a pregnancy test, a CBC, and Comprehensive metabolic panel. After these standard of care tests occur (which is a site specific trauma panel and may include a liver panel at some institutions) and the participant has been consented, a liver panel measuring alanine amino transferase (ALT) and aspartate amino transferase (AST) shall occur prior to randomization in order for the participant to be fully eligible for the study