| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Randomization was centralized and performed electronically. Allocation sequences were generated in a 1:1 ratio by a computer-generated random number using a blocking schema; the range of block sizes remains confidential until the completion of the parent trial. Randomization was stratified by center and by use of mechanical ventilation at the time of inclusion."
Comment: The allocation sequence was random. The allocation sequence was concealed. |
| Deviations from intervention |
Low |
Protocol quote: "Placebo-controlled trial. Patients, investigators and care providers
will be blinded for the patient-arm."
Comment: Blinded study. Appropriate analysis method was used (Intention-to-treat) |
| Missing outcome data |
Low |
Comment: 149 patients randomized, 149 patients analyzed. Missing data for 1 participant that withdrew consent after randomization was imputed.
Quote: "One patient withdrew consent; and for the primary outcome this patient was considered to have experienced treatment failure on day 21." Risk assessed to be low for outcomes: Mortality. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Serious adverse events |
| Measurement of the outcome |
Low |
Comment: Appropriate method of outcome measurement.
Measurement of outcome does not differ between groups. Blinded study (outcome assessors unaware of intervention assignment). Risk assessed to be low for outcomes: Mortality. Incidence of WHO score 6 and above. Incidence of WHO score 7 and above. Serious adverse events |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical analysis plan were available.
The outcomes mortality, incidence of score 7 and above are post hoc outcomes, therefore, not prespecified. Risk assessed to be low for outcomes: Incidence of WHO score 6 and above. Serious adverse events. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of WHO score 7 and above. |
| Overall risk of bias |
Low |