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: “Subjects were randomized (using stratified randomization) according to their characteristics of age, gender, marital status, and co-existing medical conditions and chronic diseases. After that, the subjects within each stratum were enlisted into separate digitally generated randomization schedules and assigned randomly to either the control or ivermectin group.”
Comment: Allocation sequence random. No information on allocation concealment. |
Deviations from intervention |
Some concerns |
Comment: No information on blinding (participants and personnel/carers)
Deviations from intended intervention arising because of the study context: No participant cross-over. No information on administration of co-interventions of interest: biologics, antivirals and corticosteroids. No information on outpatient self-medication. Hence, no information on whether deviations arose because of 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 concern for the outcome: Hospitalization or death. |
Missing outcome data |
Low |
Comment: 100 participants randomized; 100 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for the outcome: Hospitalization or death. |
Measurement of the outcome |
Low |
Quote: "The participants were contacted by phone at their preferred time by the designated physician on a daily basis to assess any appearance of COVID-19-related signs and symptoms and to evaluate the need of a specialized health care provider referral. The physician who contacted the patients for follow up did not know if they were assigned to the ivermectin or control group.”
Comment: Method of measuring the outcome probably appropriate. Measurement or ascertainment of outcome probably does not differ between groups. Blinded study (outcome assessor). Risk assessed to be low for the outcome: Hospitalization or death. |
Selection of the reported results |
Some concerns |
Comment: The prospective registry was available
Primary outcome pre-specified. Hospitalization or death not pre-specified. No information on whether the outcome was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Hospitalization or death. |
Overall risk of bias |
Some concerns |