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: "Randomization was centrally done using computer-generated sequences" “Initial dosing was done for first five patients in a staggered manner wherein after a patient was dosed, safety was monitored for 24-48 hours prior to dosing of the next patient. Once all five patients were dosed in this staggered manner, subsequent patients were enrolled such that study had patients randomized in a 2:1 ratio. Patients who were randomized, but did not receive the full infusion, were considered unevaluable and the same randomization code was used for allocation of the next patient enrolled by the study site."
Comment: Unclear whether allocation sequence was random for all patients included. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: “Open-label”
Comment: Unblinded study. No participant cross-over. Administration of co-interventions of interest - antivirals, biologics, and corticosteroids - was reported and balanced between groups. 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).WHO score 7 and above (D28).Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 32 patients randomized; 32 patients analyzed for mortality, Adverse events and serious adverse events; 30 patients analyzed WHO score 7 and above.
Two patients were excluded from analysis of clinical improvement and WHO score 7 and above due to non-receipt of drug; missingness is unlikely to be related to these outcomes. Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above (D28). Adverse events. Serious 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. Unblinded study (outcome assessor) Mortality is an observer-reported outcome not involving judgement. 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: Mortality (D28). WHO score 7 and above (D28). The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected outcomes. All these outcomes 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. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available. The prospective trial registry was available. Data analyzed and presented as pre-specified.
Results for mortality and WHO score 7 and above were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality (D28). WHO score 7 and above(D28). Adverse events and Serious adverse events were not pre-specified. No information on whether the results were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for outcomes: Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |