Trial ISRCTN21085622
Publication Abbass S, J Med Virol (2021) (published paper)
Primary outcome on the report: 1. Sum of the counted symptoms (fever, headache, generalized aches [myalgia/arthralgia]; respiratory distress combined with no evidence of deterioration [ICU admission and mechanical ventilation]) at Days 7 and 10, controlling for the corresponding count of symptoms at Day 3 for each patient; 2. mean change in oxygen saturation from Day 1 to Day 10 (based on daily recording per CRF)

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: “Randomization was carried out centrally by a stratified block randomization technique using computer-generated sequences of three balanced treatment groups (each of nearly 40 patients). Patients were stratified by admission to sites. After the delegated person obtained the patients consent, he telephoned an independent contact for allocation consignment.”
Comment: Allocation sequence random.
Allocation sequence concealed.
Deviations from intervention
Some concerns 		Quote: “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 or 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 low for the outcomes: Mortality (D28). Adverse events.
Missing outcome data
Low 		Comment: 120 participants randomized; 114 participants analyzed.
Data available for all or nearly all participants randomized.
Risk assessed to be low for the outcomes: Mortality (D28). Adverse events.
Measurement of the outcome
Some concerns 		Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups.
Unblinded study (outcome assessor)

MORTALITY
Observer-reported outcome not involving judgement.
Risk assessed to be low for the outcomes: Mortality (D28).

ADVERSE EVENTS
The authors reported on 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: Adverse events.
Selection of the reported results
Some concerns 		Comment: The registry was retrospective.

MORTALITY
Mortality outcome was not pre-specified, however, we do not consider the reporting of this outcome to be selective since mortality should be reported even if not planned.
Results were probably 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).

ADVERSE EVENTS
No information on whether the result was selected from multiple outcome measurements or analyses of the data.
No information on whether the trial was analyzed as pre-specified.
Risk assessed to be some concerns for the outcome: Adverse events.
Overall risk of bias
Some concerns