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: “Subjects were randomized 1:1 into the treatment arm (ARB) or standard of care (SOC) control arm”
Comment: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study (participants and personnel/carers) Deviations from intended intervention arising because of the study context No participant cross-over. Administration of co-interventions of interest, biologics, antivirals and corticosteroids reported and balanced between groups. Hence, deviations did not arise because of the trial context. Participants were analyzed according to their randomized groups for the outcome. Of note, 1 participant in the intervention arm was excluded from the analysis post-randomization because they did not receive the drug. This method was considered inappropriate to estimate the effect of assignment to intervention for this outcome. There was probably no substantial impact of failure to analyze participants according to their randomized groups. Risk assessed to be some concerns for the outcomes: Mortality (D60 or more). Clinical improvement (D60 or more). |
| Missing outcome data |
Low |
Comment: 32 participants randomized; 31 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D60 or more). Clinical improvement (D60 or more). |
| 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 (D60 or more). (TIME TO) CLINICAL IMPROVEMENT Clinical improvement (defined as discharge without transfer to ICU) 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 (D60 or more). |
| Selection of the reported results |
Some concerns |
Comment: The trial registry was available (dated April 8, 2020).
Outcomes not pre-specified ("Discharge without progression to ICU" and "In-hospital mortality" were reported in the paper but not pre-specified in the register, version dated April 8, 2020). 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 outcomes: Mortality (D60 or more). Clinical improvement (D60 or more). |
| Overall risk of bias |
High |