Safety and Effectiveness of SA58 Nasal Spray against SARS-CoV-2 family transmission: an exploratory single-arm trial

Wang et al., medRxiv, doi:10.1101/2023.03.19.23287462, NCT05667714, Mar 2023
Case 34% improvement lower risk ← → higher risk SA58 for COVID-19  Wang et al.  PROPHYLAXIS Does SA58 reduce COVID-19 infections? Prospective study of 432 patients in China (November - November 2022) Fewer cases with SA58 (p<0.000001) c19early.org Wang et al., medRxiv, March 2023 0 0.5 1 1.5 2+ RR
SA58 for COVID-19
54th treatment shown to reduce risk in December 2023, now with p = 0.018 from 3 studies. Efficacy is variant dependent.
Lower risk for cases.
No treatment is 100% effective. Protocols combine treatments.
6,200+ studies for 200+ treatments. c19early.org
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Exploratory single-arm trial of 70 family contacts showing a protective effect of SA58 nasal spray against household SARS-CoV-2 transmission. The incidence of infection was 62.9% in the experimental group versus 94.8% in a contemporaneous control group (n=362), suggesting that SA58 nasal spray reduced transmission risk by 33.8% overall. Using SA58 at least three times daily showed better protection than once a day.
3 studies use direct respiratory tract administration1-3
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
Standard of Care (SOC) for COVID-19 in the study country, China, is average with moderate efficacy for approved treatments4.
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risk of case, 33.7% lower, RR 0.66, p < 0.001, treatment 44 of 70 (62.9%), control 343 of 362 (94.8%), NNT 3.1.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Wang et al., 20 Mar 2023, prospective, China, preprint, 15 authors, study period 9 November, 2022 - 24 November, 2022, trial NCT05667714 (history). Contact: ronghuajin_youan@126.com, gaoq@sinovac.com.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2025 China United Kingdom Russia USA Sudan Angola Colombia Kenya Mozambique Pakistan Argentina Vietnam Peru Philippines Spain Brazil Italy France Japan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Bosnia-Herzegovina Côte d'Ivoire Eritrea Bulgaria Greece Slovakia Singapore Iceland New Zealand Czechia Mongolia Israel Trinidad and Tobago Hong Kong North Macedonia Belarus Qatar Panama Serbia CAR China favored low-cost treatments.The average efficacy of treatments was moderate.Low-cost treatments improve early treatment, andprovide complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org November 2025 China United Kingdom Russia USA Sudan Angola Colombia Kenya Mozambique Pakistan Argentina Vietnam Peru Philippines Spain Brazil Italy France Japan Nepal Ethiopia Iran Ghana Mexico South Korea Germany Bangladesh Saudi Arabia Algeria Morocco Yemen Poland India DR Congo Madagascar Thailand Uganda Venezuela Nigeria Egypt Bolivia Taiwan Zambia Fiji Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Singapore New Zealand Malawi Czechia Mongolia Israel Trinidad and Tobago North Macedonia Belarus Qatar Panama Serbia Syria China favored low-cost treatments.The average efficacy was moderate.Low-cost protocols improve early treatment,and add complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
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
Du, Yang, Zhang, Neutralizing antibodies for the prevention and treatment of COVID-19, Cellular & molecular immunology
Garcia-Beltran, Lam, Denis, Multiple SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity, Cell
Lu, Mok, Chen, Neutralization of Severe Acute Respiratory Syndrome Coronavirus 2 Omicron Variant by Sera From BNT162b2 or CoronaVac Vaccine Recipients, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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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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>", "accepted": { "date-parts": [ [ 2023, 3, 20 ] ] }, "author": [ { "affiliation": [], "family": "Wang", "given": "Lianhao", "sequence": "first" }, { "affiliation": [], "family": "Song", "given": "Rui", "sequence": "additional" }, { "affiliation": [], "family": "Hu", "given": "Yuansheng", "sequence": "additional" }, { "affiliation": [], "family": "Zeng", "given": "Gang", "sequence": "additional" }, { "affiliation": [], "family": "Sun", "given": "Keqiang", "sequence": "additional" }, { "affiliation": [], "family": "Wang", "given": "Jianfeng", "sequence": "additional" }, { "affiliation": [], "family": "Bao", "given": "Yafeng", "sequence": "additional" }, { "affiliation": [], "family": "Zhou", "given": "Yun’ao", "sequence": "additional" }, { "affiliation": [], "family": "Cheng", "given": "Long", "sequence": "additional" }, { "affiliation": [], "family": "Wu", "given": "Can", "sequence": "additional" }, { "affiliation": [], "family": "Pu", "given": "Junfan", "sequence": "additional" }, { "affiliation": [], "family": "Han", "given": "Xing", "sequence": "additional" }, { "affiliation": [], "family": "Wu", "given": "Junlan", "sequence": "additional" }, { "affiliation": [], "family": "Jin", "given": "Ronghua", "sequence": "additional" }, { "affiliation": [], "family": "Gao", "given": "Qiang", "sequence": "additional" } ], "container-title": [], "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2023, 3, 20 ] ], "date-time": "2023-03-20T22:55:10Z", "timestamp": 1679352910000 }, "deposited": { "date-parts": [ [ 2023, 3, 23 ] ], "date-time": "2023-03-23T19:15:24Z", "timestamp": 1679598924000 }, "group-title": "Infectious Diseases (except HIV/AIDS)", "indexed": { "date-parts": [ [ 2023, 3, 24 ] ], "date-time": "2023-03-24T04:45:19Z", "timestamp": 1679633119686 }, "institution": [ { "name": "medRxiv" } ], "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2023, 3, 20 ] ] }, "link": [ { "URL": "https://syndication.highwire.org/content/doi/10.1101/2023.03.19.23287462", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "246", "original-title": [], "posted": { "date-parts": [ [ 2023, 3, 20 ] ] }, "prefix": "10.1101", "published": { "date-parts": [ [ 2023, 3, 20 ] ] }, "publisher": "Cold Spring Harbor Laboratory", "reference": [ { "key": "2023032312150806000_2023.03.19.23287462v1.1", "unstructured": "World Health Organization. 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Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants. Cell 2022." }, { "DOI": "10.1016/j.celrep.2022.111845", "article-title": "Rational identification of potent and broad sarbecovirus-neutralizing antibody cocktails from SARS convalescents", "doi-asserted-by": "crossref", "first-page": "111845", "issue": "12", "journal-title": "Cell reports", "key": "2023032312150806000_2023.03.19.23287462v1.11", "volume": "41", "year": "2022" }, { "DOI": "10.1101/2022.12.27.22283698", "doi-asserted-by": "crossref", "key": "2023032312150806000_2023.03.19.23287462v1.12", "unstructured": "Si S , Jin C , Cao Y , et al. Safety and Effectiveness of SA58 Nasal Spray against COVID-19 Infection in Medical Personnel:An Open-label, Blank-controlled Study. medRxiv 2022: 2022.12.27.22283698." }, { "DOI": "10.1101/2022.12.28.22283666", "doi-asserted-by": "crossref", "key": "2023032312150806000_2023.03.19.23287462v1.13", "unstructured": "Song R , Zeng G , Yu J , et al. 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 2023: 2022.12.28.22283666." } ], "reference-count": 13, "references-count": 13, "relation": {}, "resource": { "primary": { "URL": "http://medrxiv.org/lookup/doi/10.1101/2023.03.19.23287462" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "subtype": "preprint", "title": "Safety and Effectiveness of SA58 Nasal Spray against SARS-CoV-2 family transmission: an exploratory single-arm trial", "type": "posted-content" }
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