| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: “The randomization was done by using block randomization method with varying block sizes by an independent statistician. The allocation concealment was done by using Sequentially Numbered Opaque Sealed Envelopes (SNOSE) method.”
Comment: Allocation sequence random. Allocation sequence concealed |
| Deviations from intervention |
Some concerns |
Quote: “Open label study”
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics were reported. Appropriate analysis method used; participants analyzed according to assigned intervention |
| Missing outcome data |
Low |
Comment: 31 patients randomized; 29 patients analyzed.
One patient in each arm excluded due to change in eligibility status (negative RT-PCR conversion after randomization but prior to treatment). There is evidence that the result is probably not biased (same reasons for missingness and balance of missing data). Risk assessed to be low for the outcomes: Mortality. Time to death. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality. Time to death. The authors reported on adverse events that contain clinically-detected events which 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 |
High |
Comment: Neither the protocol nor the statistical analysis plan was available at time of assessment. The prospective registry was available and specified mortality at day 28 as an outcome. The preprint article reported mortality at day 7 and day 28 as outcomes.
Result probably selected from multiple outcome measurements. Risk assessed to be high for the outcomes: Mortality. Time to death and Adverse events were not listed in the registry nor in the article as outcomes. Trial analyzed as prespecified. Result was not selected from multiple outcome measurements or analyses of the data. Risk assessed to be low for the outcomes: Time to death. Adverse events. Serious adverse events. |
| Overall risk of bias |
High |