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: "Randomisation was done by a computer‐generated random number for the assignment of participants to the losartan or amlodipine arm. A researcher who was not involved in our survey conducted the allocation in order to maintain blinding."
Comment: Allocation sequence random. Allocation sequence concealed. |
Deviations from intervention |
Some concerns |
Quote: "Till the achievement and assessment of all data, submitted cases who received drug administration and analysing the results remained blind via randomised and allocated processes." (report) "Not blinded" (registry)
Comment: Placebo was not used. Drugs were administered on different schedules. Probably single blinded (participants probably blinded and personnel/carers not blinded). No participant cross-over. No information on administration of co-interventions of interest: antivirals, biologics, and corticosteroids. Hence, no information on whether deviations arose because of the trial context. 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 outcome: Mortality (D28). Adverse events. |
Missing outcome data |
Low |
Comment: 82 participants randomized; 80 participants analyzed.
Data available for nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). 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. Unclear blinding of outcome assessor. Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). Adverse events requires clinical judgement and could be affected by knowledge of intervention receipt. Risk assessed to be some concerns for the outcome: Adverse events. |
Selection of the reported results |
Some concerns |
Comment: The trial registry was available.
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 outcomes:Mortality (D28).Adverse events. |
Overall risk of bias |
Some concerns |