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

Table 8 Required Sample Size for High-Risk Group Patients with One Interim Analysis

Required Sample Size for High-Risk Group Patients with One Interim Analysis
	Power = 80%		Power = 90%
P1	P0 = 80%	P0 = 70%	P0 = 80%	P0 = 70%
70%	473	NA	654	NA
65%	220	2235	305	3092
60%	128	575	177	795
55%	84	260	116	360
50%	59	147	81	204
45%	43	94	59	130
40%	32	64	45	89
35%	NA	46	NA	64

P0: 30 days mortality rate in the standard arm. P1: 30 days mortality rate in the treatment arm
N1: sample size for the standard care arm. N2: sample size for the treatment arm
For 80% power: probability of rejection at each look: 1^st look p < 0.006, futility look p > 0.709, final look p < 0.047
For 90% power: probability of rejection at each look: 1^st look p < 0.006, futility look p > 0.716, final look p < 0.047
1:1 randomization; ρ = 2.0. NA = Not Applicable

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