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 randomly assigned by a web-based interactive response system in a 1:1 ratio ”
Comment: Allocation sequence random Allocation sequence concealed |
| Deviations from intervention |
Some concerns |
Quote: “Triple (Participant, Care Provider, Investigator)”
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. Participants were not analyzed according to their randomized groups for the outcome. Of note, 4 participants enrolled to the 7000 mg dose cohort received 700 mg bamlanivimab (n=2) or placebo (n=2) and were included in the 700 mg analysis population (the randomization to active agent or placebo remained valid). One participant enrolled in the 700mg dose cohort received 7000 mg bamlanivimab and was included in the 7000 mg analysis population. Nevertheless, we considered the analysis to be probably appropriate to estimate the effect of assignment to intervention. Of note, 2 participants were excluded from the placebo analysis post-randomization because they did not receive the intervention. This method was considered inappropriate to estimate the effect of assignment to intervention for this outcome. There was probably no substantial impact of failure to analyze participants according to their randomized groups. Risk assessed to be some concerns for the outcomes: Mortality (D28). Mortality (D60 or more). Hospitalization or death. Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 220 participants randomized; 223 participants analyzed . Data available for nearly all participants randomized. 3 participants were originally randomized to a different comparison cohort but received interventions for this cohort; 2 participants were excluded due to non-receipt of interventions. This potential source of bias has been taken into account in domain 2. Risk assessed to be low for the outcomes: Hospitalization or death. Mortality (D28). Mortality (D60 or more). 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: Hospitalization or death. Mortality (D28). Mortality (D60 or more). Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, and prospective registry (dated August 19, 2020) were available.
Outcome pre-specified, although one of the three primary outcomes (not extracted) had two additional time points that were not in the registry. 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. Mortality (D28). Mortality (D60 or more). Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |