Post-exposure prophylaxis with SA58 (anti-SARS-COV-2 monoclonal antibody) nasal spray for the prevention of symptomatic COVID-19 in healthy adult workers: a randomized, single-blind, placebo-controlled clinical study*

Figures & data

Figure 1. Participant disposition.

Table 1. Baseline characteristics of study participants (full analysis set).

Characteristics	SA58 (n = 901)	Placebo (n = 321)	p-value
Age, median (IQR), yr	46.0 (35-52)	46.0 (35-52)	0.9934
Age groups, yr, No. (%)			0.4718
18–59	881(98)	316(98)
60+	20(2)	5(2)
Female sex, No. (%)	100(11)	32(10)	0.5755
SARS-CoV-2 RT-PCR status, No. (%)
Positive before administration	39(4)	15(5)	0.7544
Positive within 24 h of administration	38(4)	7(2)	0.1195
Duration of follow-up days, median (IQR)	2.25 (1.00-5.63)	2.79 (1.33-6.00)	0.1869

Note: IQR: interquartile range.

Figure 2. Time to first post-administration symptomatic COVID-19 (i.e. the Kaplan–Meier estimates of the cumulative risk of having COVID-19). Panel A. laboratory-confirmed symptomatic COVID-19; Panel B. SARS-CoV-2 RT-PCR positive. Abbreviation, HR, Hazard ratio; 95%CI, 95% confidence interval.

Table 2. Occurrence of SARS-CoV-2 RT-PCR positive and laboratory-confirmed symptomatic COVID-19 in SA58- and placebo-treated participants.

Variable	SA58 (n = 824)			Placebo (n = 299)			Protective efficacy of treatment (95% CI)
	No. of events	Person-days at risk	Incidence rate (per 100 person-days)	No. of events	Person-days at risk	Incidence rate (per 100 person-days)
SARS-CoV-2 RT-PCR positive	32	3078	1.04	32	1144	2.80	61.83% (37.50%−76.69%)
Symptomatic COVID-19	7	3162	0.22	14	1200	1.17	80.82% (52.41%−92.27%)
Severe COVID-19	0	3162	0	0	1200	0	NA

Table 3. Summary of adverse events.

Characteristics	SA58 (n = 901)	Placebo (n = 321)	p-Value
Treatment Emergent Adverse Events (TEAE)	221 (25)	72 (22)	0.4934
Nasal mucosal dryness	50 (6)	15 (5)	0.6640
Runny nose	29 (3)	11 (3)	0.8556
Headache	26 (3)	4 (1)	0.1398
Fever	22 (2)	11 (3)	0.4216
Nasal congestion	21 (2)	10 (3)	0.4148
Sneezing	20 (2)	5 (2)	0.6465
Cough	20 (2)	9 (3)	0.5277
Throat dryness	20 (2)	8 (2)	0.8283
Dizziness	18 (2)	5 (2)	0.8117
Sore throat	17 (2)	4 (1)	0.3133
SAEs	0	0	1
AESI	0	0	1

Note: AEs: adverse events; SAEs: severe adverse events; AESI: adverse events of special interest (i.e. allergic reaction, autoimmune reaction, and nasal and throat AEs of Grade 2 and above).

Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities, version 24.0.