Safety and Effectiveness of SA58 Nasal Spray against SARS-CoV-2 family transmission: an exploratory single-arm trial
Lianhao Wang, Rui Song, Yuansheng Hu, Gang Zeng, Keqiang Sun, Jianfeng Wang, Yafeng Bao, Yun’ao Zhou, Long Cheng, Can Wu, Junfan Pu, Xing Han, Junlan Wu, Ronghua Jin, No. 21 Qiang Gao
doi:10.1101/2023.03.19.23287462
Background: This study has assessed the protective effect of a new Anti-COVID-19 SA58 Nasal Spray (SA58 Nasal Spray) against SARS-CoV-2 infection under continuous exposure. Methods: This is an exploratory open-label, single-arm trial. To evaluate the safety and effectiveness of SA58 against SARS-CoV-2 family transmission, SA58 was administered to all enrolled family contacts at 3~6-hour intervals. The frequency of administration and adverse events (AEs) were self-reported by online questionnaire, and RT-PCR tests were used to diagnose SARS-CoV-2 infection. The effectiveness was assessed in comparison to a contemporaneous control group whose information was collected through three follow-up visits. Total effectiveness and single-day effectiveness were calculated.
Results: The incidence of SARS-CoV-2 infection was 62.9% (44/70) in the experimental group and 94.8% (343/362) in the control group. Using SA58 nasal spray at least three times per day could possibly reduce the risk of household transmission of SARS-CoV-2 by 46.7%~56.5%. The incidence of AEs was 41.4% and the severity of all AEs was mild.
Conclusion: Even under the scenario of continuous exposure to SARS-CoV-2, SA58 nasal spray remained effective in blocking viral transmission and was well tolerated.
References
Cao, Jian, Zhang, Rational identification of potent and broad sarbecovirus-neutralizing antibody cocktails from SARS convalescents, Cell reports
Cao, Su, Guo, Potent Neutralizing Antibodies against SARS-CoV-2 Identified by High-Throughput Single-Cell Sequencing of Convalescent Patients' B Cells, Cell
Cao, Wang, Jian, Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies, Nature
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Nyberg, Ferguson, Nash, Comparative analysis of the risks of hospitalisation and death associated with SARS-CoV-2 omicron (B.1.1.529) and delta (B.1.617.2) variants in England: a cohort study, Lancet
Si, Cao, Safety and Effectiveness of SA58 Nasal Spray against COVID-19 Infection in Medical Personnel:An Open-label, Blank-controlled Study, medRxiv
Song, Zeng, Yu, 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, medRxiv
Wang, Iketani, Li, Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants, Cell
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"abstract": "<jats:title>ABSTRACT</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>This study has assessed the protective effect of a new Anti-COVID-19 SA58 Nasal Spray (SA58 Nasal Spray) against SARS-CoV-2 infection under continuous exposure.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This is an exploratory open-label, single-arm trial. To evaluate the safety and effectiveness of SA58 against SARS-CoV-2 family transmission, SA58 was administered to all enrolled family contacts at 3∼6-hour intervals. The frequency of administration and adverse events (AEs) were self-reported by online questionnaire, and RT-PCR tests were used to diagnose SARS-CoV-2 infection. The effectiveness was assessed in comparison to a contemporaneous control group whose information was collected through three follow-up visits. Total effectiveness and single-day effectiveness were calculated.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The incidence of SARS-CoV-2 infection was 62.9% (44/70) in the experimental group and 94.8% (343/362) in the control group. Using SA58 nasal spray at least three times per day could possibly reduce the risk of household transmission of SARS-CoV-2 by 46.7%∼56.5%. The incidence of AEs was 41.4% and the severity of all AEs was mild.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Even under the scenario of continuous exposure to SARS-CoV-2, SA58 nasal spray remained effective in blocking viral transmission and was well tolerated.</jats:p></jats:sec>",
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