Sotrovimab, A Potential Treatment Option Non-Hospitalized High-Risk COVID Patients
As of January 2022, more than 5.4 million people worldwide have died from COVID-19. Effective therapies are needed because of mutations, limited vaccine availability, and vaccine hesitancy to provide a high barrier against viral escape and enduring coverage. In a recent study, researchers reported that a single intravenous dose of sotrovimab can be a potential treatment option...
As of January 2022, more than 5.4 million people worldwide have died from COVID-19. Effective therapies are needed because of mutations, limited vaccine availability, and vaccine hesitancy to provide a high barrier against viral escape and enduring coverage. In a recent study, researchers reported that a single intravenous dose of sotrovimab can be a potential treatment option for nonhospitalized, high-risk patients with mild to moderate COVID-19. The study findings were published in the journal JAMA on March 14, 2022.
Sotrovimab is an Fc-engineered human monoclonal antibody that contains the LS modification to enhance half-life and respiratory mucosal delivery. In contrast to other monoclonal antibodies, sotrovimab targets a highly conserved epitope in the SARS-CoV-2 spike protein at a region that does not compete with the binding of the angiotensin-converting enzyme 2.
To further explore, Dr Anil Gupta and his team conducted COVID-19 Monoclonal Antibody Efficacy Trial–Intent to Care Early (COMET-ICE) and evaluated the efficacy and adverse events of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease.
COMET-ICE is a randomized clinical trial that includes 1057 nonhospitalized patients with symptomatic, mild to moderate COVID-19 and at least 1 risk factor for progression conducted at 57 sites. The researchers randomized 1057 patients to an intravenous infusion with 500 mg of sotrovimab (n = 528) or placebo (n = 529). The major outcome assessed was the proportion of patients with COVID-19 progression through day 29 (all-cause hospitalization lasting >24 hours for acute illness management or death). They also assessed 5 secondary outcomes, tested in hierarchal order, including a composite of all-cause emergency department (ED) visit, hospitalization of any duration for acute illness management, or death through day 29 and progression to severe or critical respiratory COVID-19 requiring supplemental oxygen or mechanical ventilation.
Key findings of the study:
Among 1057 patients randomized, the median duration of follow-up was 103 days for sotrovimab and 102 days for placebo.
♦ Upon analysis, the researchers found that all-cause hospitalization lasting longer than 24 hours or death was significantly reduced with sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) (adjusted relative risk [RR], 0.21; absolute difference, –4.53%).
♦ They observed that four of the 5 secondary outcomes were statistically significant in favor of sotrovimab, including
- Reduced ED visit,
Hospitalization, or death (13/528 [2%] for sotrovimab vs 39/529 [7%] for placebo; adjusted rr, 0.34; absolute difference, –4.91%) and
Progression to severe or critical respiratory COVID-19 (7/528 [1%] for sotrovimab vs 28/529 [5%] for placebo; adjusted RR, 0.26; absolute difference, –3.97%).
They noted that the adverse events were infrequent and similar between treatment groups (22% for sotrovimab vs 23% for placebo).
The most commonly reported events were diarrhea with sotrovimab (n = 8; 2%) and COVID-19 pneumonia with placebo (n = 22; 4%).
The authors concluded, "Among nonhospitalized patients with mild to moderate COVID-19 and at risk of disease progression, a single intravenous dose of sotrovimab, compared with placebo, significantly reduced the risk of a composite endpoint of all-cause hospitalization or death through day 29. The findings support sotrovimab as a treatment option for nonhospitalized, high-risk patients with mild to moderate COVID-19, although efficacy against SARS-CoV-2 variants that have emerged since the study was completed is unknown."
For further information:
Keywords: Sotrovimab, COVID-19, SARS-CoV-2 variants, nonhospitalized patients, mild to moderate COVID-19, high-risk COVID patients, JAMA, hospitalization, death,COVID-19 pneumonia,COMET-ICE trial.
Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at email@example.com.