Sotrovimab, a monoclonal antibody has been accorded emergency use authorisation (EUA) by the US FDA for use in patients aged 12 years and older with lab-confirmed mild to moderate COVID-19 and are at risk of progression to severe disease characterised by hospitalization or even death.
Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2. It prevents virus entry into the cells by preventing the virus from attaching to the cells.
As the FDA, sotrovimab is not authorized for use in the following patients because of apprehension that it may worsen clinical outcomes in them. These include patients:
- who are hospitalized due to COVID-19
- who require oxygen therapy due to COVID-19, and/or
- who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity)
Dose and administration: Single dose (500 mg) intravenously
Side effects: Anaphylaxis, infusion-related reactions, rash, diarrhea
The evidence for the beneficial role of sotrovimab comes from an interim analysis from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial. 583 non-hospitalized adult patients with mild to moderate COVID-19 were randomized to receive either sotrovimab or placebo. Treatment with sotrovimab reduced severe outcomes by 85%. Hospitalization or death occurred in 21 (7%) patients who received placebo compared to 3 (1%) patients treated with sotrovimab.
Sotrovimab was also found to exhibit neutralising activity against viral variants in experimental studies, including activity against the variants detected in the UK, South Africa, Brazil, California and India.
A fact sheet on Sotrovimab is available on the FDA website.
The FDA had earlier granted EUAs to two combination products of monoclonal antibodies for emergency use.
- Bamlanivimab 700 mg + etesevimab 1400 mg
- Casirivimab 1200 mg + imdevimab 1200 mg.
(Source: US FDA, May 26, 2021)
Dr Sanjay Kalra, DM,
Bharti Hospital, KarnalImmediate Past President, Endocrine Society of India