Trial NCT04575584
Publication MOVe-IN - Arribas J, N Engl J Med Evidence (2021) (published paper)
Primary outcome on the report: Safety and sustained recovery: 1) Rates of adverse events reported during the safety follow-up period (from randomization through 14 days after end of treatment); 2) Adverse events leading to discontinuation of study intervention reported during the safety follow-up period; 3) Sustained recovery, defined as participants being alive and either not hospitalized or medically ready for hospital discharge through day 29

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
Randomization
Low 		Quote: "Eligible participants were randomly assigned, via a centralized intervention randomization system"
Comment: Allocation sequence random.
Allocation sequence concealed.
Imbalances in baseline characteristics appear to be compatible with chance.
Deviations from intervention
Low 		Quote: "Participants, investigators, and study staff (except unblinded site pharmacists) remained blinded to allocation assignment until study completion"
Comment: Blinded study (participants and personnel/carers).
Our analysis for the outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Incidence of viral negative conversion (D7). Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Adverse events. Serious adverse events.
Missing outcome data
Some concerns 		Comment: 304 participants randomized; 304 analyzed for mortality D60 or more, 293 participants analyzed for safety and clinical improvement; 259 participants analyzed for mortality D28 and WHO score 7 or above; 237 participants analyzed for viral negative conversion.

MORTALITY. (TIME TO) CLINICAL IMPROVEMENT. ADVERSE AND SERIOUS ADVERSE EVENTS.
Safety and clinical improvement data available for nearly all participants randomized.
Risk assessed to be low for the outcomes: Mortality (D60 or more). Clinical improvement (D28). Time to clinical improvement. Adverse events. Serious adverse events.

MORTALITY. INCIDENCE OF VIRAL NEGATIVE CONVERSION. WHO SCORE 7 AND ABOVE.
Remaining data not available for all or nearly all participants randomized.
No evidence that the result is not biased.
Reasons for missing data were not clearly reported.
Missingness could depend on the true value of the outcome.
Not likely that missingness depended on the true value of the outcome since proportions of missing data between arms were similar.
Risk assessed to be some concerns for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). WHO score 7 and above (D28).
Measurement of the outcome
Low 		Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Mortality (D28). Mortality (D60 or more). Incidence of viral negative conversion (D7). Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Adverse events. Serious adverse events.
Selection of the reported results
Low 		Comment: The protocol, statistical analysis plan, and trial registry were available.
Outcome pre-specified.
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 outcomes: Mortality (D28). Mortality (D60 or more). Incidence of viral negative conversion (D7). Clinical improvement (D28). Time to clinical improvement. WHO score 7 and above (D28). Adverse events. Serious adverse events.
Overall risk of bias
Some concerns