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 |
Some concerns |
Quote: "Simple randomization scheme was used to allocate participants in the two treatment groups. "
Comment: Allocation sequence probably random. No information on allocation concealment |
| Deviations from intervention |
Low |
Quote: “double-blinded. The blinding of the study was maintained since hospital personnel at the transfusion medicine services, physicians, and the participants were unaware which plasma was convalescent and which plasma was control.”
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). Time to death. |
| Missing outcome data |
Low |
Comment: 158 participants randomized; 158 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. |
| 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). Time to death. |
| Selection of the reported results |
Low |
Comment: The registry was available (dated May 6, 2020).
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: Mortality (D28). Time to death. |
| Overall risk of bias |
Some concerns |