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: "Random sequences were prepared using online tools (https://www.sealedenvelope.com/) and block randomization method by a person who had no role in sampling or allocating individuals to random codes. Individual random allocation was done in blocks of 2 and 4 without stratification. Inclusion criteria were monitored by the recruiter and the codes in the random sequence were assigned to the patients by the treatment team who were blinded to whether each code belonged to the intervention or placebo group. Then the patients'codes for the interventions were matched with the generated random sequence information (allocation concealment was performed by the treatment team without informing the recruiter and the person who prepared the random sequence)."
Comment: Allocation sequence random. Unclear allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: "All participants were unaware of which group they were in and received Famotidine if they were assigned to the treatment group, and placebo if they were assigned to the control group. The first author, healthcare personnel, data collectors, and those who assessed the outcomes were aware of the patient grouping. Those who drafted the article were unaware of the grouping if they were not involved in the above processes."
Comment: Unclear blinding (participants blinded and unclear if personnel/carers blinded) No participant cross-over. No information on the administration of co-interventions of interest: biologics and corticosteroids. Antivirals provided as part of the standard of care. 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 concerns for the outcome: Mortality (D28). |
| Missing outcome data |
Low |
Comment: 20 participants randomized; 20 participants analyzed.
Data available for all or nearly 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 |
Registry quote: "Registration timing: registered_while_recruiting"
Comment: The trial registry was retrospective. Mortality outcome was not pre-specified in the registry; 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. No information on whether the trial was analyzed as pre-specified. Risk assessed to be low for the outcome: Mortality (D28). |
| Overall risk of bias |
Some concerns |