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: "...randomized by a study physician, 1:1 using the electronic software REDCap. Blocks of ten patients were used for randomization."
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “open-label”
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context: No participant cross-over. Administration of co-interventions of interest reported and balanced between groups: 2/17 treatment + 1/14 control patients received antivirals (remdesivir); 11/17 + 11/14 received corticosteroids (betamethasone). Biologics is the intervention. Hence, deviations did not arise because of the trial context. 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). Adverse events. Serious adverse events. |
| Missing outcome data |
Some concerns |
Comment: 33 participants randomized; 31 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons: One patient in the SOC group withdrew consent immediately after randomization and one person in the CCP-group was excluded due to unavailability of ABO-compatible CCP. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome due to similar proportions between arms. Risk assessed to be some concerns for the outcomes: Mortality (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY Observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). ADVERSE and SERIOUS ADVERSE EVENTS The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic. Risk assessed to be some concerns for the outcomes: Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan were not available and the registry was retrospective (Oct 23, 2020).
No information on whether the result was selected from multiple outcome measurements or analyses of the data. No information on whether the trial was analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |