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: "For administering intervention, random number was generated in Excel to follow simple random sampling technique. The participants were randomly assigned in a 1:1 ratio, into two groups".
Comment: Allocation sequence random. Unclear allocation concealment (no information reported). |
| Deviations from intervention |
Some concerns |
Quote: "Of the 41 patients in the SC group... one patient requested for remdesivir treatment after four days of admission." "We did not give placebo injection in the no‑remdesivir group and did not do blinding"
Comment: Unblinded study (participants and personnel/carers). One participant crossed-over from the control to the treatment group. No information on administration of co-interventions of interest: Biologics, antivirals and corticosteroids. Hence, not enough information on whether deviations arose because of the trial context. Not all the participants were analyzed according to their randomized groups for the outcome. Of note, 1 participant randomized to the control group was analyzed in the intervention group. Nevertheless, we considered the analysis to be probably appropriate to estimate the effect of assignment to intervention. Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Missing outcome data |
Some concerns |
Comment: 82 participants randomized; 73 participants analyzed
Data not available for all participants randomized. No evidence that the result is not biased. Reasons: study flowchart partially provides the reasons for exclusions. However, it is not possible to know what happened to those participants with treatment stopped or withheld or discharged before day 5. Missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (similar proportions between arms) Risk assessed to be some concerns for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above(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). WHO SCORE 7 AND ABOVE For WHO score 7 and above, we consider that the assessment cannot possibly be influenced by knowledge of intervention assignment. Risk assessed to be low for the outcomes: WHO score 7 and above (D28). CLINICAL IMPROVEMENT Clinical improvement (defined as not hospitalized/discharged) 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). |
| Selection of the reported results |
Some concerns |
Comment: The protocol, statistical analysis plan and registry were not available.
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 (D28). Clinical improvement (D28). WHO score 7 and above (D28). |
| Overall risk of bias |
High |