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 (Ann Surg Med): “This study is randomized using simple randomization method with 2
arms study trial of 1:1 allocation (75 Niclosamide group vs. 75 control
group). The randomization process, patient’s records for disease progression,
recovery, and clinical or laboratory testing were supervised by
third party authority from Ministry of Health.”
Quote (medRxiv): "This study is a randomized controlled trial with 2 arms study trial 1:1 allocation (75 Niclosamide group vs. 75 control group). Inside each group, up to 25 mild, 25 moderate and 25 severe and/or critical patients were recruited." Comment: Allocation sequence probably random. Unclear allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "open label clinical trial".
Comment: Unblinded study (participants and personnel/carers). No participant cross-over. No information on administration of co-interventions of interest: antivirals, biologics, and corticosteroids. Hence, no information on whether deviations arose because of the trial context. Our analysis for the binary outcome is an 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: 150 participants randomized; 150 participants analyzed.
Data available for all participants randomized. 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. Unblinded study (outcome assessor). 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 protocol and statistical analysis plan were not available. The registry was available (retrospective, February 15, 2021).
Mortality outcome was not pre-specified, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |