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 participants were assigned randomly according to a randomization number generated by an independent statistician and provided in pre-sealed envelopes. Individuals involved in randomization and masking had no involvement in the rest of the trial.”
Comment: Allocation sequence random. Allocation sequence probably concealed |
| Deviations from intervention |
Low |
Quote: “Open-label”
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: No participant cross-over. In the outpatient setting, we consider no important cointerventions of interest. Hence, no deviation arose because of the trial context Hence, deviations did not arise because of the trial context. Our analysis for the binary and time-to-event outcomes is an 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). Incidence of viral negative conversion (D7). Time to viral negative conversion. WHO score 7 and above (D28). |
| Missing outcome data |
Some concerns |
Comment: Number randomized unclear "The study included one hundred and ninety patients in the three groups. Group 1 included 70 patients who received sofosbuvir/ledipasvir with SCT; Group 2 included 77 patients who received nitazoxanide with SCT; Group 3 included 73 patients who received
SCT alone"; 220 participants analyzed.
No information on whether data were available for all randomized participants. No evidence that the result is not biased. Missingness is not likely to depend on the true value of the outcome. Risk assessed to be some concerns for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. WHO score 7 and above (D28). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) MORTALITY, (TIME TO) VIRAL NEGATIVE CONVERSION Mortality and viral negative conversion are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Time to viral negative conversion. 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). |
| Selection of the reported results |
Low |
Comment: The registry was not truly prospective (registered 5 August 2020, with recruitment beginning 15 July 2020), but was early in the recruitment period and no changes were made to the registry subsequently.
Outcomes pre-specified (negative conversion explicitly and mortality/WHO score 7 and above as part of the WHO clinical scale). 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). Time to viral negative conversion. WHO score 7 and above (D28). |
| Overall risk of bias |
Some concerns |