Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19

Abstract

IMPORTANCEOlder patients and those with comorbidities who are infected with SARS-CoV-2 may be at increased risk of hospitalization and death. Sotrovimab is a neutralizing antibody for the treatment of high-risk patients to prevent COVID-19 progression.OBJECTIVE To evaluate the efficacy and adverse events of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease.DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial including 1057 nonhospitalized patients with symptomatic, mild to moderate COVID-19 and at least 1 risk factor for progression conducted at 57 sites in Brazil, Canada,

Real World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients

“…Our study adds to the main prior clinical trial demonstrating sotrovimab efficacy that had limited sample size (n=583), occurred prior to the emergence of the Delta variant, and was underpowered to evaluate the impact of sotrovimab on patient mortality. [4] This data on the effectiveness of sotrovimab to prevent severe COVID-19 disease induced by the Delta variant may be critical given the unpredictable nature of the COVID-19 pandemic. When combined with in vitro data that suggests sotrovimab effectively neutralizes the omicron variant, [20] these data support continued sotrovimab prioritization among outpatient treatment options.…”

“…Several mAb products have received emergency use authorization (EUA) from the US Food and Drug Administration [2] based on Phase II/III randomized clinical trials conducted earlier in the pandemic that demonstrated efficacy towards reduced hospitalization and disease severity among high-risk outpatients. [3][4][5] Use of mAb products such as sotrovimab for individuals who have recently tested positive for SARS-CoV-2 in the outpatient setting is critical to mitigate virus-driven impact on the health care system and is also an evidence-based treatment strategy to improve COVID-19 outcomes among high-risk individuals.…”

“…Trials supporting mAb EUA approval were conducted prior to the emergence of the Delta variant surge in the summer 2021, and the trial assessing sotrovimab efficacy was limited in assessment of clinical outcomes or mortality. [4] Following EUA, however, it becomes more challenging to recruit patients into randomized controlled trials. [6] As new variants such as Delta and Omicron emerge, analysis of real-world data sufficiently robust to evaluate important clinical differences is critical to evaluate treatment effectiveness and inform policy and practice decisions.…”

Monoclonal Antibody Therapy in Kidney Transplant Recipients With Delta and Omicron Variants of SARS-CoV-2: A Single-Center Case Series

“…We repeated viral load measurements 7-8 days after monoclonal antibody infusion according to previously published studies reporting on monoclonal antibody therapy. 21 , 22 …”

Lack of efficacy for sotrovimab use in patients with COVID-19: A meta-analysis

“…The electronic literature search identified a total of 4 studies 4 , 5 , 6 , 7 comprising of 3866 adult patients with COVID-19, including 1040 in the sotrovimab (administered alone) and 2826 in the control group arm, were included in this meta-analysis. The patient demographics and baseline disease characteristics of the study population are shown in Table 1 .…”