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: "Simple randomization was
performed using the GraphPad QuickCalcs Web site by a statistician with no contact with patient care." Comment: Allocation sequence concealed. |
Deviations from intervention |
Some concerns |
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context: 1 patient in the intervention arm never received the drug (telmisartan). No information on review co-interventions of interest: antivirals and biologics. Hence, not enough information on whether deviations arose because of the trial context. MORTALITY, CLINICAL IMPROVEMENT, ADVERSE EVENTS Data for the outcome were analyzed using intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). Adverse Events. TIME TO CLINICAL IMPROVEMENT Participants were analyzed according to their randomized groups for the outcome. Of note, 1 vs 3 participants were excluded from the analysis post-randomization due to reasons unrelated to missing data (eligibility criteria and did not receive the drug). This method was considered appropriate to estimate the effect of assignment to intervention for this outcome. Risk assessed to be some concerns for the outcome: Time to clinical improvement. |
Missing outcome data |
Some concerns |
Comment: 162 participants randomized; 158 participants analyzed for Clinical improvement, Time to clinical improvement, and Adverse Events; 141 participants analyzed for Mortality.
(TIME TO) CLINICAL IMPROVEMENT, ADVERSE EVENTS Data available for nearly all participants randomized. Risk assessed to be low for outcomes: Clinical improvement (D28). Time to clinical improvement. Adverse Events. MORTALITY Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons for missingness unclear Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (proportion of missingness balanced between arms). Risk assessed to be some concerns for outcome: Mortality (D28). |
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 Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). (TIME TO) CLINICAL IMPROVEMENT Clinical improvement (defined as discharge from the hospital) requires clinical judgement and could be affected by knowledge of intervention receipt, but it not considered likely to in the context of a pandemic. Risk assessed to be some concerns for the outcomes: Clinical improvement (D28). Time to clinical improvement. 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. |
Selection of the reported results |
Some concerns |
Comment: Protocol and statistical analysis plan are available but retrospective (dated July 12th, 2020) but the supplementary reported the changes. The registry was prospective (May 13th, 2020 version consulted).
MORTALITY, ADVERSE EVENTS 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 outcomes: Mortality (D28). Adverse events. (TIME TO) CLINICAL IMPROVEMENT Outcome not pre-specified No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Clinical improvement (D28). Time to clinical improvement. |
Overall risk of bias |
Some concerns |