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:"A randomization schedule was created electronically and
simple randomization was performed."
Quote:""Randomization will be conducted via excel by Dr. . ...Transplant patients will be randomized in a 1:1 ratio. " Comment: Allocation probably random. No information on allocation concealment |
| Deviations from intervention |
Some concerns |
Quote: “ patient-blinded"
Comment: Blinded study (participants) Deviations from intended intervention arising because of the study context: No participant cross-over. Hence, deviations did not arise because of the trial context. Per-protocol analysis was performed on the outcomes. Reasons for exclusion: participant declared that had received monoclonal antibody and discontinued intervention (1 vs 0); acquiring SARS-CoV- 2 infection prior to the second blood draw (1 vs 0) br/>As we are assessing the effect of assignment to intervention (intention-to-treat effect), we considered that the data were analyzed inappropriately. There was probably no substantial impact of failure to analyze participants according to their randomized assignment due to small number of exclusions. Risk assessed to be some concerns for the outcomes: Mortality. Adverse events( AE) . Serious adverse events (SAE). |
| Missing outcome data |
Low |
Comment: [60] participants randomized; [58] participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality. 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. ADVERSE and SERIOUS ADVERSE EVENTS The authors reported on 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 registry and protocol were available but retrospective (regsitry dated September 16, 2021) two days after the start of the study, Available Protocol Version Date: March 7, 2022
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.Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |