[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-410421-105":59,"doc-detail-410421-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","safety-tolerability-pharmacokinetics-and-viral-pharmacodynamics-of-the-monoclonal-antibody-sotrovimab-administered-via-intramuscular-injection-in-participants-with-early-mild-to-moderate-covid-19-a-randomized-clinical-trial","Safety, Tolerability, Pharmacokinetics, and Viral Pharmacodynamics of the Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection in Participants with Early, Mild-to-Moderate COVID-19 - A Randomized Clinical Trial","","Objective and background focus on increasing access to COVID-19 therapeutics through intramuscular (IM) formulations. COMET-PEAK evaluates sotrovimab safety, tolerability, pharmacokinetics, and viral pharmacodynamics in adults with early, mild-to-moderate disease. Parts compare 500-mg IV infusion with 500-mg or 250-mg IM injection. Primary virologic equivalence uses mean SARS-CoV-2 viral load area under the curve day 1–8 and 90% CI criteria. Results show IM well tolerated and equivalent to 500-mg IV without new safety signals; viral load biomarker validity needs further study.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/safety-tolerability-pharmacokinetics-and-viral-pharmacodynamics-of-the-monoclonal-antibody-sotrovimab-administered-via-intramuscular-injection-in-participants-with-early-mild-to-moderate-covid-19-a-randomized-clinical-trial/410421/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/safety-tolerability-pharmacokinetics-and-viral-pharmacodynamics-of-the-monoclonal-antibody-sotrovimab-administered-via-intramuscular-injection-in-participants-with-early-mild-to-moderate-covid-19-a-randomized-clinical-trial/410421.png","ImageObject",300,407,{"name":92,"@type":93},"\tCallum ","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-28",true,{"@type":102,"interactionType":103,"userInteractionCount":52},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the main purpose of COMET-PEAK in early, mild-to-moderate COVID-19?","Question",{"text":112,"@type":113},"To assess the safety, tolerability, pharmacokinetics, and viral pharmacodynamics of sotrovimab given by IV infusion or IM injection.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How did the study define success for the primary virologic objective?",{"text":117,"@type":113},"Equivalence was assessed using the ratio of geometric mean SARS-CoV-2 viral load AUCD1–8 for IM versus IV, with 90% confidence interval limits of 0.5–2.0.",{"name":119,"@type":110,"acceptedAnswer":120},"What did the results show about IM administration of sotrovimab compared with IV?",{"text":121,"@type":113},"IM administration was well tolerated, showed no new safety signals, and the viral load changes were equivalent to 500 mg IV for both IM doses.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},410421,1790716664,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":52,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},137451211410,"https://ap-avatar.wpscdn.com/avatar/2000bb0a9246f588df?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786362646172706240","Drugs in R&D (2025) 25:353–365  \n[https://doi.org/10.1007/s40268-025-00529-2](https://doi.org/10.1007/s40268-025-00529-2)  \nSafety, Tolerability, Pharmacokinetics, and Viral Pharmacodynamics of the Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection in Participants with Early, Mild‑to‑Moderate COVID‑19: A Randomized Clinical Trial  \nAnil Gupta1 · Maria Teresa Perez‑Rodríguez2 · Yaneicy Gonzalez‑Rojas3 · Moti Ramgopal4 · Almena Free5 · Jennifer Han6,13 · Jennifer Moore7 · Naomi Givens8 · Phillip J. Yates8 · Jill T. Walker6 · Mary Beth Connolly9 · Gretja Schnell10 · Varsha Imber7 · Rabia Anselm7 · Lindsay Winograd11 · Scott Segal6 · Stephen Harrison8 · Andrew Skingsley7 · Melissa Aldinger10 · Amanda Peppercorn6 · Jaynier Moya12  \nReceived: 4 April 2025 / Accepted: 10 November 2025 / Published online: 24 November 2025 © The Author(s) 2025  \nAbstract  \nBackground and Objectives New coronavirus disease 2019 (COVID-19) therapeutics, including intramuscular (IM) formulations, may increase patient access. In COMET-TAIL, sotrovimab 500 mg IM was non-inferior to 500 mg intravenous (IV) in reducing the risk of COVID-19 progression; however, 250 mg IM was associated with more hospitalizations, despite similar viral load (VL) reductions to 500 mg IM.  \nMethods COMET-PEAK was a randomized, three-part study to assess safety, tolerability, and viral pharmacodynamics of sotrovimab in adults with early, mild-to-moderate COVID-19. Parts B/C evaluated sotrovimab 500-mg IV infusion versus 500-mg or 250-mg IM injection. The primary objective was to compare virologic response of sotrovimab IM versus IV (mean area under the curve from day 1 to day 8 [AUCD1–8] of severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] VL); 90% confidence interval (CI) limits of 0.5–2.0 indicated equivalence.  \nResults Parts B/C included 167 and 157 participants, respectively. Median age range was 42–47 years, and approximately 50% of participants had one or more risk factor for severe disease. The primary objective was met: the ratio of geometric mean VL AUCD1–8 of sotrovimab IM versus IV was 1.04 (90% CI 0.98–1.09; Part B) and 1.02 (90% CI 0.94–1.11; Part C) . No new safety signals emerged for sotrovimab; IM administration was well tolerated, with few injection-site reactions. Conclusions Both sotrovimab IM doses were equivalent to 500 mg IV with respect to SARS-CoV-2 VL change. IM administration was safe and well tolerated. The validity of VL as a biomarker for COVID-19 progression warrants further study. Clinical Trial Registration NCT04779879 (date of first registration: March 3, 2021), [https://classic](https://classic).clinicaltrials.gov/ct2/ show/NCT04779879 .  \n1 Introduction  \nSince the World Health Organization declared coronavirus disease 2019 (COVID-19) to be a global pandemic in March 2020, the COVID-19 landscape has continued to evolve, both in terms of viral variants and treatment options. There are multiple opportunities for therapeuticsto mitigate the burden of COVID-19 disease, including treatments that limit progression of disease in mild-tomoderate cases, reduce mortality and long-term morbidity in severe cases, and protect individuals from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection both before and after exposure. The COVID-19  \npandemic also stimulated the development and authorization of several vaccines, although reported effectiveness has been variable, and uptake has been limited [1–4] .  \nSotrovimab is a dual-action engineered human IgG1κ monoclonal antibody (mAb) derived from the parental mAb S309, a potent neutralizing mAb directed against the receptor-binding domain of the spike protein of SARSCoV-2 [5–8]. In the pivotal COMET-ICE phase III clinical trial, a 500-mg intravenous (IV) infusion of sotrovimab resulted in a statistically significant 79% reduction in relative risk (0 . 21, 95% confidence interval [CI] 0.09–0. 50) compared with placebo of all-cause >24-h hospitalization or death","cbCaimRr61L1K4b2","https://ap.wps.com/l/cbCaimRr61L1K4b2","pdf",970164,13,"English","# Abstract\n# Introduction\n# Methods\n## Study Design and Endpoints","[{\"question\":\"What was the main purpose of COMET-PEAK in early, mild-to-moderate COVID-19?\",\"answer\":\"To assess the safety, tolerability, pharmacokinetics, and viral pharmacodynamics of sotrovimab given by IV infusion or IM injection.\"},{\"question\":\"How did the study define success for the primary virologic objective?\",\"answer\":\"Equivalence was assessed using the ratio of geometric mean SARS-CoV-2 viral load AUCD1–8 for IM versus IV, with 90% confidence interval limits of 0.5–2.0.\"},{\"question\":\"What did the results show about IM administration of sotrovimab compared with IV?\",\"answer\":\"IM administration was well tolerated, showed no new safety signals, and the viral load changes were equivalent to 500 mg IV for both IM doses.\"}]","Safety, Tolerability, Pharmacokinetics, and Viral Pharmacodynamics of the Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection in Participants with Early, Mild-to-Moderate COVID-19 - A Randomized Clinical Trial | PDF",1790585247,33]