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
Monoclonal antibodies (mAbs) and the post-exposure prophylaxis (PEP) with mAbs represent a very important public health strategy against coronavirus disease 2019 (COVID-19). This study has assessed a new Anti-SARS-COV-2 mAb (SA58) Nasal Spray for PEP against COVID-19 in healthy 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 3:1 to receive SA58 or placebo. Primary endpoints were laboratory-confirmed symptomatic COVID-19 within the study period. A total of 1222 participants were randomized and dosed (SA58, n = 901; placebo, n = 321). Median of follow-up was 2.25 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. 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 reverse transcriptase polymerase chain reaction (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 and all were the Omicron variant BF.7. In conclusion, SA58 Nasal Spray showed favourable efficacy and safety in preventing symptomatic COVID-19 or SARS-CoV-2 infection in adults who had exposure to SARS-CoV-2 within 72 h.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:12 |
|---|---|
| Enthalten in: |
Emerging microbes & infections - 12(2023), 1 vom: 23. Dez., Seite 2212806 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Song, Rui [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antibodies, Viral |
|---|
| Anmerkungen: |
Date Completed 29.05.2023 Date Revised 29.05.2023 published: Print Citation Status MEDLINE |
|---|
| doi: |
10.1080/22221751.2023.2212806 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM356602591 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM356602591 | ||
| 003 | DE-627 | ||
| 005 | 20231226070819.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1080/22221751.2023.2212806 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1188.xml |
| 035 | |a (DE-627)NLM356602591 | ||
| 035 | |a (NLM)37157134 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Song, Rui |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Post-exposure prophylaxis with SA58 (anti-SARS-COV-2 monoclonal antibody) nasal spray for the prevention of symptomatic COVID-19 in healthy adult workers |b a randomized, single-blind, placebo-controlled clinical study |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 29.05.2023 | ||
| 500 | |a Date Revised 29.05.2023 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Monoclonal antibodies (mAbs) and the post-exposure prophylaxis (PEP) with mAbs represent a very important public health strategy against coronavirus disease 2019 (COVID-19). This study has assessed a new Anti-SARS-COV-2 mAb (SA58) Nasal Spray for PEP against COVID-19 in healthy 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 3:1 to receive SA58 or placebo. Primary endpoints were laboratory-confirmed symptomatic COVID-19 within the study period. A total of 1222 participants were randomized and dosed (SA58, n = 901; placebo, n = 321). Median of follow-up was 2.25 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. 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 reverse transcriptase polymerase chain reaction (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 and all were the Omicron variant BF.7. In conclusion, SA58 Nasal Spray showed favourable efficacy and safety in preventing symptomatic COVID-19 or SARS-CoV-2 infection in adults who had exposure to SARS-CoV-2 within 72 h | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a China | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Monoclonal antibodies | |
| 650 | 4 | |a Post-exposure prophylaxis | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 7 | |a Nasal Sprays |2 NLM | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 700 | 1 | |a Zeng, Gang |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Jianxing |e verfasserin |4 aut | |
| 700 | 1 | |a Meng, Xing |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Xiaoyou |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jing |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, Xiaoliang |e verfasserin |4 aut | |
| 700 | 1 | |a Lian, Xiaojuan |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Zhiyun |e verfasserin |4 aut | |
| 700 | 1 | |a Cao, Yunlong |e verfasserin |4 aut | |
| 700 | 1 | |a Yin, Weidong |e verfasserin |4 aut | |
| 700 | 1 | |a Jin, Ronghua |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Emerging microbes & infections |d 2012 |g 12(2023), 1 vom: 23. Dez., Seite 2212806 |w (DE-627)NLM249608804 |x 2222-1751 |7 nnns |
| 773 | 1 | 8 | |g volume:12 |g year:2023 |g number:1 |g day:23 |g month:12 |g pages:2212806 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1080/22221751.2023.2212806 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 12 |j 2023 |e 1 |b 23 |c 12 |h 2212806 | ||