The overall objective of the study is to evaluate the clinical efficacy of COVID-19
treatments consisting of standard of care (SOC), vs SOC with high dose famotidine in patients
hospitalized and meeting radiologic criteria for COVID-19 disease. SOC for the treatment for
COVID-19 has evolved since the initial conceptualization of this protocol and early
recruitment of patients. Initially SOC included hydroxychloroquine and has progressed to
include Remdesivir. This protocol is amended to allow the SOC to reflect the prevailing
treatment for COVID-19. We will compare clinical outcomes associated with SOC and the
addition of high-dose intravascular famotidine. The trial is designed to enroll at least 471
COVID-19 patients hospitalized with moderate to severe disease into each of the two treatment
arms, with a total enrollment target of at least 942 patients. This trial has been designed
and powered to support up to three interim analyses that will enable prompt assessment of
benefits and risks of the two treatment groups while maintaining the rigorous gold standard
of a randomized double blind clinical trial structure. Trial design has been guided by
practical consideration of the current clinical context involving rapidly escalating demands
on hospital staff and resources, and incorporates a minimalist approach employing existing
laboratory information management systems and a clinically relevant binary primary outcome of
30-day endpoint of death or survival.