| Bias | Author's judgement | Support for judgement |
| Randomization |
Some concerns |
Quote: "Upon signing the informed consent form and screening, 60 eligible patients with
pneumonia associated with PCR confirmed COVID-19 were randomized at a 1:1:1 ratio to
receive either AVIFAVIR 1600 mg BID on Day 1 followed by 600 mg BID on Days 2-14
(1600/600 mg), or AVIFAVIR 1800 mg BID on Day 1 followed by 800 mg BID on Days 2-14
(1800/800 mg), or SOC." Comment: There was no information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study.
No information on cross-over (no flow chart). Co-intervention administration of corticosteroids, antivirals, and biologics are reported. Outcome data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Low |
60 randomized, 60 analyzed. Risk assessed to be low for outcomes: Incidence of viral negative conversion. Clinical improvement. Adverse events |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study.
Viral negative conversion is an observer-reported outcomes not involving judgement. Therefore, we consider that the assessment cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for outcome: Incidence of viral negative conversion. Clinical improvement (the definition is discharge from the hospital) reflects a decision made by the intervention provider where the assessment could possibly be influenced by knowledge of the intervention assignment however we did not consider this likely in the context of a pandemic. Adverse events may contain both clinically- and laboratory-detected outcomes, therefore it can be influenced by knowledge of the intervention assignment, but is not likely to. Risk assessed to be some concerns for outcomes: Clinical improvement. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: There was no protocol or statistical analysis plan available. The registry was available and utilized.
Outcomes related to clinical improvement and safety were neither registered as outcomes nor reported as such in the paper. Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for outcomes: Clinical improvement. Adverse events. Incidence of viral negative conversion were listed in the registry with different timepoints compared to those reported for the outcome in the paper. No information on whether the result was selected from multiple outcome measurements (timepoints) or analyses of the data. Trial was not analyzed as pre-specified. Risk assessed to be some concerns for outcome: Incidence of viral negative conversion. |
| Overall risk of bias |
Some concerns |