Statistical design of Phase II/III clinical trials for testing therapeutic interventions in COVID-19 patients

Table 10 Required Sample Size for High-Risk Group Patients with Two Interim Analyses

Required Sample Size for High-Risk Group Patients with Two Interim Analyses
	Power = 80%		Power = 90%
P1	P0 = 80%	P0 = 70%	P0 = 80%	P0 = 70%
70%	476	NA	660	NA
65%	222	2250	308	3122
60%	129	579	179	803
55%	84	262	117	363
50%	59	148	82	206
45%	43	95	60	131
40%	33	65	45	90
35%	NA	46	NA	64

P0: 30 days mortality rate in standard arm. P1: 30 days mortality rate in treatment arm
For 80% power: probability of rejection at each look: 1^st look p < 0.002, futility look p > 0.835, 2^nd look p < 0.015, futility look p > 0.312, final look p < 0.046
For 90% power: probability of rejection at each look: 1^st look p < 0.002, futility look p > 0.830, 2^nd look p < 0.015, futility look p > 0.297, final look p < 0.046
1:1 randomization; ρ = 3.0. NA = Not Applicable

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