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
DOI record:
{
"DOI": "10.1101/2023.03.19.23287462",
"URL": "http://dx.doi.org/10.1101/2023.03.19.23287462",
"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>",
"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. COVID-19 vaccine tracker and landscape. Available at: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines/."
},
{
"DOI": "10.1016/j.cell.2021.03.013",
"article-title": "Multiple SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity",
"doi-asserted-by": "crossref",
"first-page": "2372",
"issue": "9",
"journal-title": "Cell",
"key": "2023032312150806000_2023.03.19.23287462v1.2",
"volume": "184",
"year": "2021"
},
{
"DOI": "10.1093/cid/ciab1041",
"article-title": "Neutralization of Severe Acute Respiratory Syndrome Coronavirus 2 Omicron Variant by Sera From BNT162b2 or CoronaVac Vaccine Recipients",
"doi-asserted-by": "crossref",
"first-page": "e822",
"issue": "1",
"journal-title": "Clinical infectious diseases: an official publication of the Infectious Diseases Society of America",
"key": "2023032312150806000_2023.03.19.23287462v1.3",
"volume": "75",
"year": "2022"
},
{
"key": "2023032312150806000_2023.03.19.23287462v1.4",
"unstructured": "Geneva: World Health Organization. WHO COVID-19 Dashboard. Available at: https://covid19.who.int/."
},
{
"DOI": "10.1016/S0140-6736(22)00462-7",
"article-title": "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",
"doi-asserted-by": "crossref",
"first-page": "1303",
"issue": "10332",
"journal-title": "Lancet (London, England)",
"key": "2023032312150806000_2023.03.19.23287462v1.5",
"volume": "399",
"year": "2022"
},
{
"key": "2023032312150806000_2023.03.19.23287462v1.6",
"unstructured": "Health CfHPotDo. Provisional Data Analysis on COVID-19 Reported Death Cases."
},
{
"DOI": "10.1038/s41423-021-00752-2",
"article-title": "Neutralizing antibodies for the prevention and treatment of COVID-19",
"doi-asserted-by": "crossref",
"first-page": "2293",
"issue": "10",
"journal-title": "Cellular & molecular immunology",
"key": "2023032312150806000_2023.03.19.23287462v1.7",
"volume": "18",
"year": "2021"
},
{
"DOI": "10.1038/s41586-021-04385-3",
"article-title": "Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies",
"doi-asserted-by": "crossref",
"first-page": "657",
"issue": "7898",
"journal-title": "Nature",
"key": "2023032312150806000_2023.03.19.23287462v1.8",
"volume": "602",
"year": "2022"
},
{
"DOI": "10.1016/j.cell.2020.05.025",
"article-title": "Potent Neutralizing Antibodies against SARS-CoV-2 Identified by High-Throughput Single-Cell Sequencing of Convalescent Patients’ B Cells",
"doi-asserted-by": "crossref",
"first-page": "73",
"issue": "1",
"journal-title": "Cell",
"key": "2023032312150806000_2023.03.19.23287462v1.9",
"volume": "182",
"year": "2020"
},
{
"DOI": "10.1101/2022.11.23.517532",
"doi-asserted-by": "crossref",
"key": "2023032312150806000_2023.03.19.23287462v1.10",
"unstructured": "Wang Q , Iketani S , Li Z , et al. 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"
}
