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|
|Quote: “This Phase 2 study is designed as a proof of concept study and will randomize 2:1 approximately 120 patients with COVID-19 associated acute hypoxemia: of which 80 patients will receive sargramostim plus standard of care, and 40 patients who will receive standard of care alone. ”
Comment: Allocation sequence probably random.
No information on allocation concealment.
|Deviations from intervention||
|Quote: “Masking: None (Open Label)”
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
No participant cross-over.
No information on administration of co-interventions of interest: antivirals, corticosteroids, biologics.
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 outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events.
|Missing outcome data||
|Comment: 122 participants randomized; 122 participants analyzed.
Data available for all participants randomized.
Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Serious adverse events.
|Measurement of the outcome||
|Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor)
Observer-reported outcome not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more).
SERIOUS ADVERSE EVENTS
The authors reported on adverse events and serious adverse events that may contain both clinically- and laboratory-detected events, which can be influenced by knowledge of the intervention assignment, but is not likely in the context of the pandemic.
Risk assessed to be some concerns for the outcomes: Serious adverse events
|Selection of the reported results||
|Comment: The protocol, statistical analysis plan, registry were available (dated June 2, 2020).
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 outcome: Mortality (D28). Mortality (D60 or more).
SERIOUS ADVERSE EVENTS
Outcome not pre-specified in the version of the prospective registry dated August 18, 2020.
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
Trial probably not analyzed as pre-specified.
Risk assessed to be some concerns for the outcome: Serious adverse events
|Overall risk of bias||