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

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

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
  1. P0: 30 days mortality rate in the standard arm. P1: 30 days mortality rate in the treatment arm
  2. N1: sample size for the standard care arm. N2: sample size for the treatment arm
  3. For 80% power: probability of rejection at each look: 1st look p < 0.006, futility look p > 0.709, final look p < 0.047
  4. For 90% power: probability of rejection at each look: 1st look p < 0.006, futility look p > 0.716, final look p < 0.047
  5. 1:1 randomization; ρ = 2.0. NA = Not Applicable