| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "An electronically generated randomization 2:1 list was prepared by independent statisticians" "The list was accessible only to nonmasked specialists in the study in an attempt to minimize observation bias" Comment: It was not clear whether the allocation was concealed or not. Baseline characteristics between intervention groups were comparable (except for high blood pressure and diabetes mellitus, known risk factors for unfavorable disease progression, which were more frequent in patients not treated with calcifediol); any differences appear to be compatible with chance. |
| Deviations from intervention |
Some concerns |
Quote:"This pilot study has several limitations as it is not double-blind placebo controlled" Comment: Information on key co-interventions such as antivirals and corticosteroids was not reported No indication of participant cross-over/treatment not received. Outcome data were analyzed by using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 76 randomized/76 analyzed for all outomes (pilot study). Risk assessed to be low for outcome: Mortality. Incidence of score WHO 7 or above. |
| Measurement of the outcome |
Some concerns |
Comment: Open lable trial. Death is an observer reported outcome that cannot be influenced by knowledge of the intervention assignment. Risk assessed to be low for the outcome: Mortality. Incidence of score WHO 7 and above is an observer reported outcome that can be influenced by knowledge of the intervention assignment. Risk assessed to be low for the outcome: Incidence of score WHO 7 and above. |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available. Risk assessed to be some concerns for the outcome: Mortality. Incidence of score WHO 7 and above. |
| Overall risk of bias |
Some concerns |