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

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

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
Effect Size	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

N1: sample size for the standard care arm. N2: sample size for the treatment arm
Response rate = 40%

ISSN: 1471-2288