Luisa Frallonardo, Antonella Vimercati, Roberta Novara, Cherola Lepera, Ilaria Ferrante, Giulia Chiarello, Rossana Cicinelli, Michele Mongelli, Gaetano Brindicci, Francesco Vladimiro Segala, Carmen Rita Santoro, Davide Fiore Bavaro, Nicola Laforgia, Ettore Cicinelli, Annalisa Saracino, Francesco Di Gennaro
{"title":"在 COVID 19 进展风险较高的孕妇群体中使用索托维单抗:单中心经验。","authors":"Luisa Frallonardo, Antonella Vimercati, Roberta Novara, Cherola Lepera, Ilaria Ferrante, Giulia Chiarello, Rossana Cicinelli, Michele Mongelli, Gaetano Brindicci, Francesco Vladimiro Segala, Carmen Rita Santoro, Davide Fiore Bavaro, Nicola Laforgia, Ettore Cicinelli, Annalisa Saracino, Francesco Di Gennaro","doi":"10.1080/20477724.2023.2188839","DOIUrl":null,"url":null,"abstract":"<p><p>Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.</p>","PeriodicalId":19850,"journal":{"name":"Pathogens and Global Health","volume":null,"pages":null},"PeriodicalIF":4.9000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10262799/pdf/","citationCount":"0","resultStr":"{\"title\":\"Use of Sotrovimab in a cohort of pregnant women with a high risk of COVID 19 progression: a single-center experience.\",\"authors\":\"Luisa Frallonardo, Antonella Vimercati, Roberta Novara, Cherola Lepera, Ilaria Ferrante, Giulia Chiarello, Rossana Cicinelli, Michele Mongelli, Gaetano Brindicci, Francesco Vladimiro Segala, Carmen Rita Santoro, Davide Fiore Bavaro, Nicola Laforgia, Ettore Cicinelli, Annalisa Saracino, Francesco Di Gennaro\",\"doi\":\"10.1080/20477724.2023.2188839\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.</p>\",\"PeriodicalId\":19850,\"journal\":{\"name\":\"Pathogens and Global Health\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.9000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10262799/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pathogens and Global Health\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/20477724.2023.2188839\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/3/10 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"PARASITOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pathogens and Global Health","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/20477724.2023.2188839","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/3/10 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PARASITOLOGY","Score":null,"Total":0}
Use of Sotrovimab in a cohort of pregnant women with a high risk of COVID 19 progression: a single-center experience.
Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.
期刊介绍:
Pathogens and Global Health is a journal of infectious disease and public health that focuses on the translation of molecular, immunological, genomics and epidemiological knowledge into control measures for global health threat. The journal publishes original innovative research papers, reviews articles and interviews policy makers and opinion leaders on health subjects of international relevance. It provides a forum for scientific, ethical and political discussion of new innovative solutions for controlling and eradicating infectious diseases, with particular emphasis on those diseases affecting the poorest regions of the world.