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: "randomized" (report)
"The trial study nurses will use the randomisation module in Research Electronic Data Capture (REDCap)"; "The trial nurses will then maintain a separate database on a password protected computer of treatment allocation. These nurses are responsible for intervention preparation of zinc or placebo in 250ml saline bags labeled with the participant's details and then distributed to the treating medical team for administration. No other members of the treating or research team will have access to the treatment allocation or preparation of interventions." (registry) Comment: Allocation sequence probably random. Allocation sequence probably concealed. |
| Deviations from intervention |
Low |
Quote: "The investigators, study coordinators, treating physicians, bedside nurses and patients/family remained blinded to the allocated study solution"
Comment: Blinded study (participants and personnel/carers). 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 low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Missing outcome data |
Low |
Comment: 39 participants randomized; 33 participants analyzed.
Data not available for all or nearly all participants randomized. No evidence that the result is not biased. Reasons for missing data:- withdrew consent before first infusion due to: declined canula (n=2), raised concern regarding infusion time (1), raised concern regarding the treatment (1), discharged 2 hours after enrolment (1), withdrew following difficulty inserting the canula (1). Missingness could not depend on the true value of the outcome. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, and registry were available.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified for the outcomes collected. Risk assessed to be low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
Low |