| 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 (clinical team). Comment: Blinding of participants uncertain. No information on co-interventions of interest: antivirals, biologics and corticosteroids. Data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Low |
Comment: 24 patients randomized; 24 patients analyzed.
Data available for 100% of population. Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. WHO score 7 and above. 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. Incidence of viral negative conversion. WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |