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Post-Exposure Prophylaxis with SA58 (anti-COVID-19 monoclonal antibody) Nasal Spray for the prevention of symptomatic Coronavirus Disease 2019 in healthy adult workers: A randomized, single-blind, placebo-controlled clinical study (preprint)
medrxiv; 2023.
Preprint
in English
| medRxiv | ID: ppzbmed-10.1101.2022.12.28.22283666
ABSTRACT
BACKGROUND This study has assessed a new Anti-COVID-19 Monoclonal Antibody Nasal Spray (SA58) for post-exposure prophylaxis (PEP) against symptomatic coronavirus disease 2019 (COVID-19). METHODS We conducted an efficacy study in adults aged 18 years and older within three days of exposure to a SARS-CoV-2 infected individual. Recruited participants were randomized in a ratio of 31 to receive SA58 or placebo. Primary endpoints were laboratory-confirmed symptomatic COVID-19 within study period. FINDINGS A total of 1,222 participants were randomized and dosed (SA58, n=901; placebo, n=321). Median of follow-up was 2.25 days and 2.79 days for SA58 and placebo, respectively. Adverse events occurred in 221 of 901 (25%) and 72 of 321 (22%) participants with SA58 and placebo, respectively, with no significant difference (P=0.49). All adverse events were mild in severity. Laboratory-confirmed symptomatic COVID-19 developed in 7 of 824 participants (0.22 per 100 person-days) in the SA58 group vs 14 of 299 (1.17 per 100 person-days) in the placebo group, resulting in an estimated efficacy of 80.82% (95%CI 52.41%-92.27%). There were 32 SARS-CoV-2 RT-PCR positives (1.04 per 100 person-days) in the SA58 group vs 32 (2.80 per 100 person-days) in the placebo group, resulting in an estimated efficacy of 61.83% (95%CI 37.50%-76.69%). A total of 21 RT-PCR positive samples were sequenced. 21 lineages of SARS-CoV-2 variants were identified, and all were the Omicron variant BF.7. INTERPRETATION SA58 Nasal Spray showed favorable efficacy and safety in preventing SARS-CoV-2 infection or symptomatic COVID-19 in healthy adult workers who had exposure to SARS-CoV-2 within 72 hours.
Full text:
Available
Collection:
Preprints
Database:
medRxiv
Main subject:
Severe Acute Respiratory Syndrome
/
COVID-19
Language:
English
Year:
2023
Document Type:
Preprint
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