Table 1.

EVD Trial Characteristics

Study Endpoint	28-day Mortality
Treatments	Experimental: cycle through ranked list of candidate therapies or allow concurrent evaluation if therapies are equally ranked; control: concurrent control group of oSOC; control group may change if evidence accumulates to support superiority of a given investigational product and therefore incorporation of that element into new background oSOC
Randomization	Equal allocation to each study arm; permuted blocks of small size
Stratification factors	Location (Liberia or Sierra Leone, Guinea, United States); disease severity (cycle threshold, >22 of ≤22)
Monitoring	Aggressive early monitoring, with the possibility of stopping the trial, under extreme circumstances after enrollment of only 6 subjects per arm
Type I error rate	Less strict than usual
No. of patients	Target of up to 100 per arm, recognizing that final analysis will occur if epidemic ends before complete enrollment

Abbreviations: EVD, Ebola virus disease; oSOC, optimal standard of care.