Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: “Participants were centrally randomized to either bamlanivimab and etesevimab together
(700/1400mg) or placebo (0.9% sodium chloride solution), using an interactive web response
system. Randomization was stratified by patients’ symptom duration (≤8 days versus >8 days), and
age at the time of screening (<18 years of age versus ≥18 years of age).”
Comment: Allocation sequence random Allocation sequence concealed Imbalances in baseline characteristics appear to be compatible with chance |
| Deviations from intervention |
Low |
Quote: “double-blind. For the blinded treatment arms, neither participants, nor investigators, nor the sponsor study team will be aware of treatment assignments prior to the final data base locks at the conclusion of the study”
Comment: Blinded study (participants and personnel/carers) Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 782 participants randomized; 760 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Hospitalization or death. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The prospective registry was available (dated June 11, 2020, up to the version dated December 3, 2020).
MORTALITY Mortality outcome was not pre-specified in the registry, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). HOSPITALIZATION OR DEATH Outcome pre-specified. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Hospitalization or death. ADVERSE EVENTS, SERIOUS ADVERSE EVENTS Outcome not pre-specified No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |