| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: “web-based simple (unstratified) randomisation with
allocation concealed
until after randomisation.”
Comment: Allocation sequence random. Allocation sequence concealed Imbalances in baseline characteristics appear to be compatible with chance |
| Deviations from intervention |
Low |
Quote: "open-label study"
Comment: Unblinded study. 5 of 3410 patients with completed follow-up allocated to usual care received lopinavir-ritonavir. 1394 of 1603 patients with completed follow-up at time of analysis allocated to lopinavir-ritonavir received lopinavir-ritonavir. Deviation too small to affect outcome. Administration of co-intervention of interest: antivirals, corticosteroids and biologics were reported and balanced between groups. Data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Low |
Comment: 5040 patients randomized; 5040 patients analyzed.
Follow-up information was complete for 5018 (>99%) of 5040 patients. Risk assessed to be low for the outcomes: Mortality. Incidence of clinical improvement. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study
Mortality is a observer-reported outcome not involving judgement. Risk assessed to be low for the outcome: Mortality. Clinical improvement (defined as hospital discharge before day 28) could 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 outcome: Incidence of clinical improvement. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical analysis plan were available. Result was not selected from multiple outcome measurements nor multiple analyses of the data. Trial was analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. Incidence of clinical improvement. |
| Overall risk of bias |
Some concerns |