Table 3 Primary and secondary virological outcomes (nasopharyngeal SARS-CoV-2 RNA) by bamlanivimab dose cohort and treatment arm

	7000 mg dose cohort				700 mg dose cohort
Primary virological outcome: Proportion NP SARS-CoV-2 RNA not detected	Bamlanivimab (N = 48)	Placebo (N = 46)	Risk ratio, bamlanivimab vs placebo (95% CI)^a	Risk difference, bamlanivimab vs placebo (95% CI)	Bamlanivimab (N = 111)	Placebo (N = 112)	Risk ratio, bamlanivimab vs placebo (95% CI)^a	Risk difference, bamlanivimab vs placebo (95% CI)
	NP SARS-CoV-2 RNA not detected, n (%)	NP SARS-CoV-2 RNA not detected, n (%)	Risk ratio, bamlanivimab vs placebo (95% CI)^a	Risk difference, bamlanivimab vs placebo (95% CI)	NP SARS-CoV-2 RNA not detected, n (%)	NP SARS-CoV-2 RNA not detected, n (%)	Risk ratio, bamlanivimab vs placebo (95% CI)^a	Risk difference, bamlanivimab vs placebo (95% CI)
Day 0	5 (10.4)	8 (18.2)	–	–	5 (4.6)	6 (5.4)	–	–
Missing	0	2			2	0
Day 3	8 (17.4)	8 (18.2)	0.97 (0.44, 2.16)	−0.01 (−0.17, 0.15)	8 (7.6)	7 (6.5)	1.21 (0.48, 3.06)	0.01 (−0.06, 0.08)
Missing	2	2			6	5
Day 7	11 (23.9)	10 (23.3)	1.05 (0.53, 2.08)	0.01 (−0.17, 0.18)	13 (12.5)	17 (16.0)	0.81 (0.43, 1.53)	−0.04 (−0.13, 0.06)
Missing	2	3			7	6
Day 14	24 (52.2)	28 (66.7)	0.82 (0.60, 1.12)	−0.14 (−0.35, 0.06)	35 (35.0)	33 (32.4)	1.09 (0.75, 1.57)	0.03 (−0.10, 0.16)
Missing	2	4			11	10
Day 21	32 (69.6)	32 (80.0)	0.91 (0.71, 1.15)	−0.10 (−0.29, 0.08)	66 (64.1)	56 (53.8)	1.20 (0.95, 1.51)	0.10 (−0.03, 0.24)
Missing	2	6			8	8
Day 28	34 (72.3)	33 (78.6)	0.98 (0.76, 1.25)	−0.06 (−0.24, 0.12)	70 (72.2)	66 (64.1)	1.13 (0.93, 1.39)	0.08 (−0.05, 0.21)
Missing	1	4			14	9
Overall p-value^b			0.88				0.49

Secondary outcome: Quantitative NP SARS-CoV-2 RNA levels	NP SARS-CoV-2 RNA level, Median (Q1, Q3), log₁₀ copies/mL	NP SARS-CoV-2 RNA level, Median (Q1, Q3), log₁₀ copies/mL	p-value^c	−	NP SARS-CoV-2 RNA level, Median (Q1, Q3), log₁₀ copies/mL	NP SARS-CoV-2 RNA level, Median (Q1, Q3), log₁₀ copies/mL	p-value^c	−
Day 0	5.2 (2.5, 6.6) (n = 48)	5.0 (1.7, 6.9) (n = 45)	−	−	5.5 (4.0, 6.8) (n = 109)	5.7 (3.8, 6.8) (n = 112)	−	−
Day 3	2.2 (1.7, 4.2) (n = 46)	3.4 (1.7, 5.7) (n = 44)	p = 0.07	−	2.9 (1.7, 3.9) (n = 105)	3.9 (2.4, 5.1) (n = 107)	p = 0.002	−
Day 7	1.7 (0.7, 2.5) (n = 46)	2.1 (1.7, 3.4) (n = 43)	p = 0.14	−	2.1 (1.7, 3.0) (n = 104)	2.2 (1.7, 3.1) (n = 106)	p = 0.89	−
Day 14	0.7 (0.7, 1.7) (n = 46)	0.7 (0.7, 1.7) (n = 42)	p = 0.27	−	1.7 (0.7, 1.7) (n = 100)	1.7 (0.7, 1.7) (n = 102)	p = 0.90	−
Day 21	0.7 (0.7, 1.7) (n = 46)	0.7 (0.7, 0.7) (n = 40)	p = 0.31	−	0.7 (0.7, 1.7) (n = 103)	0.7 (0.7, 1.7) (n = 104)	p = 0.29	−
Day 28	0.7 (0.7, 1.7) (n = 47)	0.7 (0.7, 0.7) (n = 42)	p = 0.40	−	0.7 (0.7, 1.7) (n = 97)	0.7 (0.7, 1.7) (n = 103)	p = 0.17	−

Secondary outcome: AUC of NP SARS-CoV-2 RNA from day 0 through day 28	AUC of NP SARS-CoV-2 RNA, Median (Q1, Q3)	AUC of NP SARS-CoV-2 RNA, Median (Q1, Q3)	p-value^c		AUC of NP SARS-CoV-2 RNA, Median (Q1, Q3)	AUC of NP SARS-CoV-2 RNA, Median (Q1, Q3)	p-value^c
AUC (days x days x log₁₀ copies/mL)	6.4 (1.9, 17.1) (n = 48)	13.5 (1.4, 28.8) (n = 45)	p = 0.14		12.6 (7.6, 22.4) (n = 109)	15.8 (7.6, 25.8) (n = 112)	p = 0.19

CI confidence interval, NP nasopharyngeal, RNA ribonucleic acid, AUC area under the curve of log₁₀ RNA and above the assay lower limit of quantification (2 log₁₀ copies/mL). ^aLog-binomial model failed to converge thus Poisson regression model for repeated measures with robust variance and log-link fit with generalized estimating equations with an independence working correlation structure used to generate RRs and 95% CIs, ^btwo-sided Wald chi-square test, ^ctwo-sided Wilcoxon-Mann-Whitney test.

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