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Table 5 Required Sample Size for Intermediate-Risk Group Patients with No Interim Analysis

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

Required Sample Size for Intermediate-Risk Group Patients with No Interim Analysis
Effect Size   α = 0.05 with 1:1 Group Ratio α = 0.05 with 1:2 Group Ratio
Power 80% 90% 80% 90%
10% N1 303 420 226 313
N2 303 420 452 626
Total 606 840 678 939
15% N1 134 186 100 139
N2 134 186 200 278
Total 268 372 300 417
20% N1 75 103 56 78
N2 75 103 112 156
Total 150 206 168 234
25% N1 47 65 35 49
N2 47 65 70 98
Total 94 130 105 147
30% N1 31 43 24 33
N2 31 43 48 66
Total 62 86 72 99
35% N1 22 30 17 24
N2 22 30 34 48
Total 44 60 51 72
40% N1 16 22 13 18
N2 16 22 26 36
Total 32 44 39 54
  1. N1: sample size for the standard care arm. N2: sample size for the treatment arm
  2. Response rate = 40%