Trial IRCT20200328046882N1
Publication Alavi-moghaddam M, SSRN, 2021
Primary outcome on the report: Clinical recovery by normal body temperature (≤37.2°C oral, or 36.6°C armpit, or 37.8°C rectal) and normal oxygen saturation rate (≥94% on room air), sustained for 72 hours since initiation of antiviral treatment

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
Some concerns 		Quote: "computer-generated randomization plan"
Comment: Allocation sequence random. No information on allocation concealment.
Deviations from intervention
Some concerns 		Quote: "The clinicians and patients were not blinded and the principle investigator, outcome assessor and data analyzer were masked."
Comment: Unblinded study (participants and personnel/carers).
Deviations from intended intervention arising because of the study context:
No participant cross-over.
Co-interventions of interest: all received antivirals, information on corticosteroids or biologics were not reported.
Hence, no information on whether deviations arose because of the trial context.
Data for the outcome were analyzed using 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 outcome: Mortality (D28).
Missing outcome data
Low 		Comment: 57 participants randomized; 57 participants analyzed.
Data available for all participants randomized.
Risk assessed to be low for the outcome: Mortality (D28).
Measurement of the outcome
Low 		Quote: "principle investigator, outcome assessor and data analyzer were masked"
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 outcome: Mortality (D28).
Selection of the reported results
Low 		Comment: The trial registry was 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 outcome: Mortality (D28).
Overall risk of bias
Some concerns