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Emerg Microbes Infect
. 2023 May 8;2212806.
doi: 10.1080/22221751.2023.2212806. Online ahead of print. 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
Rui Song 1 , Gang Zeng 2 , Jianxing Yu 2 , Xing Meng 2 , Xiaoyou Chen 1 , Jing Li 3 , Xiaoliang Xie 4 5 , Xiaojuan Lian 3 , Zhiyun Zhang 1 , Yunlong Cao 4 5 , Weidong Yin 2 , Ronghua Jin 1
Affiliations
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 study period. 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. 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 favorable efficacy and safety in preventing symptomatic COVID-19 or SARS-CoV-2 infection in adults who had exposure to SARS-CoV-2 within 72 hours.Trial registration: ClinicalTrials.gov identifier: NCT05667714..
Keywords: COVID-19; China; Clinical trial; Monoclonal antibodies; Post-exposure prophylaxis; SARS-CoV-2.
. 2023 May 8;2212806.
doi: 10.1080/22221751.2023.2212806. Online ahead of print. 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
Rui Song 1 , Gang Zeng 2 , Jianxing Yu 2 , Xing Meng 2 , Xiaoyou Chen 1 , Jing Li 3 , Xiaoliang Xie 4 5 , Xiaojuan Lian 3 , Zhiyun Zhang 1 , Yunlong Cao 4 5 , Weidong Yin 2 , Ronghua Jin 1
Affiliations
- PMID: 37157134
- DOI: 10.1080/22221751.2023.2212806
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 study period. 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. 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 favorable efficacy and safety in preventing symptomatic COVID-19 or SARS-CoV-2 infection in adults who had exposure to SARS-CoV-2 within 72 hours.Trial registration: ClinicalTrials.gov identifier: NCT05667714..
Keywords: COVID-19; China; Clinical trial; Monoclonal antibodies; Post-exposure prophylaxis; SARS-CoV-2.