[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Sotrovimab
Control
Overall
Included criteria: •Patient must be 18 years of age or older AND at high risk of progression of Covid-19 based on presence of one or more of the following risk factors: oDiabetes (requiring medication)oObesityoChronic kidney diseaseoCongestive heart failureoChronic obstructive pulmonary diseaseOr•Patient 55 years of age or older, irrespective of comorbiditiesNote: target enrollment of ~15% of patients over 70 years of ageType of Patient and Disease Characteristics•Patients who have a positive SARS-CoV-2 test result (by any validated diagnostic test [e.g. RT-PCR, antigen-based testing on any specimen type])and•Oxygen saturation ≥94% on room airand•Have Covid-19 defined by one or more of the following symptoms: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhea, shortness of breath on exertionand•Less than or equal to 5 days from onset of symptoms
Excluded criteria: Pregnancy
Pretreatment:
Intervention Characteristics
Sotrovimab
Control
All-cause mortality (Day 28)
All-cause mortality (Day 14)
All-cause mortality (End of treatment)
Invasive mechanical ventilation or death
Invasive mechanical ventilation
Duration of invasive mechanical ventilation
NIV / HFNO
Duration of NIV / HFNO
Supplemental oxygen
Duration of supplemental oxygen
Respiratory failure or ARDS
Serious adverse events
Adverse events
Discontinuation due to an adverse event
Septic shock
Dyspnea / breathlessness resolution
Hospitalisation
ICU admission
Duration of hospital stay
Discharge from hospital
Clinical recovery
Time to recovery
Clinical improvement
Time to improvement
Clinical deterioration
Time to deterioration
Sponsorship source: Vir Biotechnology, Inc in collaboration with GlaxoSmithKline
Country: United states
Setting: Outpatients
Comments:
Authors name: Adrienne E. Shapiro
Institution: Departments of Global Health and Medicine, University of Washington and Fred Hutchinson Cancer Research
Email: aeshapir@uw.edu
Address: Fred Hutchinson Cancer Research CenterMailstop E5-1101100 Fairview Avenue NorthSeattle, WA 98109
Clinical trial identifier: ClinicalTrials.gov NCT04545060
Preprint or peer reviewed: Preprint
Single centre or multi-centre (no. of centres): Multi-centre 37
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Judgement Comment: Changes made to SAP and protocol during the study including changing some secondary outcomes.
Judgement Comment: Outcome data are available for all participants other than those that withdrew consent.
Judgement Comment: Participants, caregiver and outcome assessors were unlikely to be aware of treatment allocation, appropriate ITT analysis.
Judgement Comment: Limited information on the randomisation process and concealment of allocation. Baseline characteristics balanced.