| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: “Patients were randomly assigned” (report)
"Random number table method" (registry) Comment: Allocation sequence random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Quote: “open-label trial”
Comment: Unblinded study. No participant cross-over. No information on administration of co-interventions of interest: anticoagulants. Biologics and antibiotics were reported Appropriate analysis method used; participants analyzed according to assigned intervention |
| Missing outcome data |
Low |
Comment: 50 patients randomized; 48 patients analyzed.
Two participants dropped out from the combination treatment group after adverse reactions. Data available for >95% of population Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Incidence of clinical improvement. Adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality and viral negative conversion are observer-reported outcomes not involving judgement. Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Clinical improvement is defined as discharge whose criteria include "significant improvements of respiratory symptoms and CT imaging". Adverse events events reported contain both patient-reported and clinically-detected events. Both of these outcomes 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: Incidence of clinical improvement. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol nor the statistical analysis plan was available.
In the prospective registry there was no detail on the measure time point and measure method for the primary outcome - Days form positive to negative viral nucleic acid testing. Adverse events, mortality and hospital length of stay/discharge were not specified in the registry. Risk assessed to be some concerns for the outcomes: Mortality. Incidence of viral negative conversion. Incidence of clinical improvement. Adverse events. |
| Overall risk of bias |
High |