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 |
Low |
Quote: “Eligible patients were randomly allocated to either the standard, Placebo and the Ivermectin arms. The transposed block randomization sequence, including stratification, was prepared by a statistician not involved in the trial using Random Allocation Software. The patients in six treatment arms enrolment were randomized after calling the central randomization telephone number and receiving randomization information and confirmation.”
Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Some concerns |
Quote: "Groups that have been masked" "Participant, Care provider, Outcome assessor, Data analyser" (registry) Comment: Two groups received a single dose, two groups received 3 doses, and the standard care group did not receive any doses. For this reason it is not likely that patients or personnel/carers were blind to treatment group. Deviations from intended intervention arising because of the study context: No indication of patient cross-over. No information on administration of co-interventions of interest, corticosteroids, antivirals and biologics. 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 the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 180 patients randomized; 180 patients analyzed.
Data available for all participants. Risk assessed to be low for the outcome: Mortality (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. Blinded study (outcome assessor), although this is unlikely. Mortality is an observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality (D28). |
| Selection of the reported results |
Low |
Comment: The trial registry was available. The protocol and statistical analysis plan were not.
Mortality was not listed as an outcome in the registry. However, we considered the reporting of this outcome acceptable as mortality should be reported even if not planned. Results were not selected from multiple outcome measurements or analyses of the data. Trial probably analyzed as pre-specified. Risk assessed to be low for outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |