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: "The randomization sequence was computer-generated by the trial statistician using blocks of four to ensure balance. Allocation was made by the attending investigator using opaque envelopes."
Comment: Allocation sequence random. Unclear allocation sequence concealment (unclear whether the envelopes were sealed or sequentially-numbered; furthermore blinding is not perfect; single center; block of four) |
| Deviations from intervention |
Some concerns |
Quote: “Pilot, randomized, double-blind, placebo-controlled trial”
Quote: "The placebo tablets did not match ivermectin in appearance, therefore, in order for the clinical team to remain blinded, treatment was administered under direct supervision by a nurse not participating in patient's care." Comment: Blinded study (personnel/carers). Blinding of participants unclear. Deviations from intended intervention arising because of the study context: No participant cross-over. No information on co-interventions of interest: antivirals, biologics and corticosteroids. Hence, no information on deviations that arose due to 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 outcome: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Missing outcome data |
Low |
Comment: 24 patients randomized; 24 patients analyzed.
Data available for all or nearly all participants. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcomes probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| 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. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28). Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |