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: "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: Allocation sequence probably random. No information on allocation concealment. |
| Deviations from intervention |
Some concerns |
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context: No information on cross-over (no flow chart). Co-intervention administration of corticosteroids, antivirals, and biologics are 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 outcomes: Incidence of viral negative conversion (D7). Clinical improvement (D28). Adverse events. |
| Missing outcome data |
Low |
Comment: 60 participants randomized, 60 participants analyzed.
Data available for all participants randomized. Risk assessed to be low for outcomes: Incidence of viral negative conversion (D7). Clinical improvement (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) VIRAL NEGATIVE CONVERSION Viral negative conversion is an observer-reported outcomes not involving judgement. Risk assessed to be low for outcome: Incidence of viral negative conversion (D7). CLINICAL IMPROVEMENT 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. Risk assessed to be some concerns for outcome: Clinical improvement (D28). ADVERSE EVENTS 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 in the context of a pandemic. Risk assessed to be some concerns for outcome: Adverse events. |
| Selection of the reported results |
Some concerns |
Comment: There was no protocol or statistical analysis plan available. The registry was available but retrospective (dated June 16th, 2020).
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 outcomes: Incidence of viral negative conversion (D7). Clinical improvement (D28). Adverse events. |
| Overall risk of bias |
Some concerns |