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 Clinical Trial Unit generated the randomization sequence using permuted blocks of 3 or 6 by computer-generated random numbers without stratification.”
Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Low |
Quote: “double-blind, randomized, placebo-controlled, multicenter trial”
“Two tablets 100 mg camostat mesilate or two placebo tablets similar in size and color were administered.... All trial personnel were blinded to randomization” Comment: Blinded study (participants and personnel/carers) BINARY OUTCOMES 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 low for the outcomes: Mortality (D28). Clinical improvement (D28). WHO score 7 and above (D28). Adverse events. Serious adverse events. TIME-TO-EVENT OUTCOMES Participants were analyzed according to their randomized groups for the outcome. Of note, 2 vs 1 participants were excluded from the analysis post-randomization, 2 of which were due to reasons other than missing data (ineligibility exclusion - false positive PCR and >48 hours after admission). This method was considered inappropriate to estimate the effect of assignment to intervention for this outcome. Risk assessed to be low for the outcomes: Time to death. Time to clinical improvement. Time to WHO score 7 and above. |
| Missing outcome data |
Low |
Comment: 208 participants randomized; 205 participants analyzed.
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| 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). Risk assessed to be low for the outcomes: Mortality (D28). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol (dated March 30th, 2020), statistical analysis plan and registry (dated March 24th, 2020) were available.
Outcomes pre-specified. 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). Time to death. Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Time to WHO score 7 and above. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |