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Gupta A, et al. "Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab". The New England Journal of Medicine. 2021. 385:1941-1950.
PubMed • Full text • PDF
PubMed • Full text • PDF
Clinical Question
In patients with mild to moderate COVID-19 will Sotrovimab reduce hospitalization or mortality
Bottom Line
There are too many va
Major Points
Guidelines
Design
- Multicenter, Double-blind, Phase 3 trial, Placebo group
Population
Inclusion Criteria
- 18 years of age or older and at high risk of progression of Covid-19 based on at least one risk factor
- diabetes
- obesity
- chronic kidney disease
- congestive heart failure
- chronic obstructive pulmonary disease
- 55 years of age or older
- positive SARS-CoV-2 test result
- oxygen saturation of 94% and more on room air
- Covid-19 symptoms
- fever
- chills
- cough
- sore
- throat
- malaise
- headache
- joint
- muscle pain
- change in smell or taste
- vomiting
- diarrhea
- shortness of breath on exertion
- less than or equal to 5 days from onset of symptoms
Exclusion Criteria
- Likely to require hospitalization in the next 24 hours
- Symptoms consistent with severe Covid-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen
- likely to die in the next 7 days
- Pregnant
- Breastfeeding
- Known hypersensitivity to any constituent present in the investigational product
- Previous anaphylaxis or hypersensitivity to a monoclonal antibody
- Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to day 1 or within five half-lives of the investigational compound
- Whichever is longer, enrollment in any trial of an investigational vaccine for SARS-CoV-2
- Severely immunocompromised patients
- Any vaccine within 48 hours prior to enrollment
- Convalescent plasma from a recovered Covid-19 patient anti–SARS-CoV-2 monoclonal antibody within the last 3 months
- Unlikely or unable to comply with the requirements of the protocol through day 29
Baseline Characteristics
Interventions
Outcomes
'
Primary Outcomes
- = hospitalization for more than 24 hours or died from any cause through day 29, alive and not hospitalized
Secondary Outcomes
Criticisms
- Causes of death were not specified
Funding
- Vir Biotechnology and GlaxoSmithKline