| 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, antibiotics 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. Incidence of clinical improvement. Adverse events |
| Measurement of the outcome |
Some concerns |
Comment: 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: Incidence of clinical improvement. Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: There was no protocol or statistical analysis plan available. Risk assessed to be some concerns for outcomes. Incidence of viral negative conversion. Incidence of clinical improvement. Adverse events. |
| Overall risk of bias |
Some concerns |