1. In patients with mild-to-moderate coronavirus disease 2019 (COVID-19), sotrovimab reduced the risk of disease progression.
2. Sotrovimab was associated with no significant adverse events in high-risk patients with mild-to-moderate COVID-19.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Several vaccines have been approved for the prevention of COVID-19. Although, many individuals are still infected on a daily basis globally and require intervention to reduce associated morbidity and mortality. Sotrovimab is an engineered human monoclonal antibody that neutralizes SARS-CoV-2 and multiple other sarbecoviruses. It has been proposed that sotrovimab can be used in high-risk patients infected with COVID-19 to neutralize the virus and prevent disease progression early in the course of infection. However, there is a paucity of data on the efficacy and safety of sotrovimab use in high-risk ambulatory patients with mild-to-moderate COVID-19. The present study found that sotrovimab was an effective therapeutic agent for outpatients with COVID-19, resulting in a reduced risk of disease progression. This study was limited by a low number of hospitalizations in the sotrovimab group. Accordingly, it is unclear which patient or disease characteristics might be associated with sotrovimab treatment failure. Additionally, there was no analysis of baseline autologous antibody response to SARS-CoV-2 to measure immune response and status. Nevertheless, the findings are significant as they demonstrate that sotrovimab can potentially serve as a new therapeutic drug for high-risk patients with mild to moderate COVID-19 to slow disease progression.
Click to read the study in NEJM.
Relevant Reading: Early Treatment with Sotrovimab for COVID-19
In-Depth [randomized control trial]: This randomized, double-blind, placebo-controlled trial was conducted at 37 trial sites in the United States, Canada, Brazil, and Spain. Patients who were 18 years of age or older with a positive result on PCR or antigen SARS-CoV-2 testing and COVID-19 symptoms within the previous five days were eligible for the study. Patients who already had severe COVID-19, defined as shortness of breath at rest or use of supplemental oxygen, were excluded from the study. Study participants were then randomly assigned to receive either a single 500mg infusion of sotrovimab or an equal volume of saline placebo. The primary outcome was measured as the percentage of patients who were hospitalized for more than 24 hours or who died from any cause up to day 29 after randomization. Outcomes in the primary analysis were assessed via group-sequential design with two interim analyses to assess both futility due to lack of efficacy and efficacy. Based on the analysis, 1% of patients in the sotrovimab group and 7% of patients in the placebo group had disease progression leading to hospitalization or death (relative risk reduction, 85%; 97.24% Confidence Interval, 44 to 96). Within the placebo group, five of these patients were admitted to the ICU, including one who died by day 29. Regarding the safety profile of sotrovimab, 17% of patients reported adverse events in the sotrovimab group while 19% of patients in the placebo reported adverse events. Serious adverse events were also less common with sotrovimab than with placebo, occurring in 2% of patients in the sotrovimab group and in 6% of patients in the placebo group. Overall, this study demonstrates that sotrovimab reduced the risk of disease progression among high-risk patients with mild-to-moderate COVID-19 and offers a new therapeutic agent to potentially reduce the progression of COVID-19.
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