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: "We randomized patients, unstratified, in a 1:1 ratio. We performed randomization through the global Solidarity trial until Jan. 29, 2021, and then in Canada until Apr. 1, 2021, through a Web-based server."
Comment: Allocation sequence random Allocation sequence concealed Imbalances in baseline characteristics appear to be compatible with chance |
| Deviations from intervention |
Some concerns |
Quote: “CATCO is a pragmatic, multicentre randomized controlled trial, in which multiple agents are compared against the currently available standard of care in an open-label fashion”
Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: corticosteroids, biologics. Antivirals were the intervention. Hence, no information on whether deviations arose 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. Of note, 3 (remdesivir) vs 0 participants were excluded from the analysis post-randomization because they refused the investigational product or removed their intravenous access. Risk assessed to be some concerns for the outcomes: Mortality (D60 or more). |
| Missing outcome data |
High |
Comment: 1282 participants randomized; 1052 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons:230 patients withdrew consent or were lost to follow-up post-discharge Risk assessed to be high for the outcome: Mortality (D60 or more). |
| Measurement of the outcome |
Low |
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 (D60 or more). |
| Selection of the reported results |
Low |
Comment: The registry was available (dated April 1, 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 (D60 or more). |
| Overall risk of bias |
High |