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. 2023 Jan 26;2023(1):CD015167. doi: 10.1002/14651858.CD015167.pub2

Risk of bias for analysis 7.6 Admission to ICU on day 28.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Gaborit 2021 Low risk of bias Participants were randomized via EnnovClinical software block randomization method in a 1:1 ratio or 5:1 ratio, to receive either XAV‐19 plus SOC or only SOC. The allocation sequence was random and concealed. There are no baseline differences that would suggest a problem with randomisation. Low risk of bias Both participants and carers and people delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate. One patient withdrew consent before the second infusion, but this will probably not have a substantial impact on the study results: "18 patients with COVID‐19‐related moderate pneumonia were randomized: 1 withdrew consent before the day 5 second infusion". Low risk of bias Data for this outcome was available for 17 out of 18 participants randomized. Low risk of bias The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were not aware of the intervention received. Some concerns The data that produced this result was analysed in accordance with the predefined outcomes stated in the trial registration, but it was unclear whether the timepoint was the same. Some concerns For the outcome "ICU admission", there are some concerns about the risk of bias due to multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain as the timepoint for this outcome was not specified in the paper.