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. 2024 Feb 5;2024(2):CD015219. doi: 10.1002/14651858.CD015219.pub2

Risk of bias for analysis 2.1 All‐cause mortality – at 28 to 30 days, or in‐hospital.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Subgroup 2.1.1 Ambulatory, mild
AlQahatani 2022 Low risk of bias The allocation sequence was random. No information regarding allocation concealement but there is not much differences in the baseline characters, except for the number of diabetes patients:‐ 22% patients in Favipiravir group and 38% in control group. Low risk of bias There was no deviations from the intended intervention and appropriate analysis was done.only 1 patient in the favipiravir group stopped taking medicine due to headache. (1/54) Low risk of bias No outcomes were missing for mortality. Low risk of bias No bias in measurement. Low risk of bias Clinical trials registration. NCT04387760. Registration date: 07/05/2020. Mortality rate was mentioned and is reported, Low risk of bias All the domains are low risk of bias.
Golan 2022 Low risk of bias "Randomization was performed via an Interactive Web Randomization System and maintained by a third party."
Comment: Allocation sequence random.
Allocation sequence probably concealed.
Imbalances in baseline differences not significant. Low risk of bias "double‐blind" study.
Comment: Blinded study (participants and personnel/carers). Low risk of bias data available for all randomised Low risk of bias Method of measuring the outcome probably appropriate. Low risk of bias The prospective registry was available (dated October 23, 2020) Outcome pre‐specified.Results were not selected from multiple outcome measurements or analyses of the data.
Trial analyzed as pre‐specified. Low risk of bias low
Shah 2023 Low risk of bias Eligible patients were randomly assigned using a permuted block design, in a 1:1 ratio, to receive open‐label oral favipiravir plus standard care or standard care alone. Randomisation was conducted by an appropriately delegated member of the study team, using a centralised online portal.
Baseline character distribution was similar.
Low risk of bias OPEN label trial. All analyses were
performed using STATA 13·1 and according to the
principle of intention to treat. Data are presented as
hazard ratios (HRs) with 95% CIs. All statistical tests
were two‐sided and a p value of less than 0·05 was
considered significant. No data was imputed and missing
data was assumed to occur at random.
The PIONEER study was registered with ClinicalTrials.
gov, NCT04373733. Low risk of bias 499 randomised and all outcomes are available. Low risk of bias No bias in measuring mortality. Low risk of bias protocol and analysis plan available Low risk of bias All domains are low risk of bias.
Subgroup 2.1.2 Moderate, severe or critical
Mahmudie 2022 Some concerns Double‐blind study.
Randomly allocated into two groups.
Permuted balanced blocked randomization using a sealed envelope website. Allocation concealment is also guaranteed by the same.
some differences in baseline characteristics were reported between groups. Age not matched.Favipiravir:‐ 34.86 (15.95) vs placebo:‐71.91 (15.87)
Hb low, WBC high, Lymphocytes high, platelets high, ESR high, PCO2 high, PCO3 high in Favipiravir group
High risk of bias Double blind allocation concealed
no information regarding if appropriate analysis were used to estimate the effect of assignment to intervention
Low risk of bias data for this outcome is available for all participants randomized(n=97) High risk of bias method of measuring the outcome‐no information.
Outcome assessors were not aware of the intervention‐double blind study
High risk of bias no information if data were produced as a result of a pre‐specified analysis plan and multiple eligible outcome measurements were used within the outcome domain. High risk of bias high risk
Solaymani‐Dodaran 2021 Low risk of bias “Sealed envelopes were used to protect the randomization sequence. We used a central allocation mechanism in which participating centers called a central randomization unit, and registered their eligible patients to receive the 4‐digit unique code for assigned group identification” allocation sequence random and concealed.Baseline differences balanced between groups Low risk of bias Open Label trial. No details about whether patients aware of their allocated treatment.No obvious deviation from intervention and Performed Modified ITT for analysis which can be considered appropriate Low risk of bias data for this outcome available for all participants randomized Low risk of bias low risk Some concerns no information on pre‐specified analysis plan Some concerns some concerns
Tabarsi 2021 Low risk of bias “The allocation was according to the block randomization method. 16 blocks, including 4 patients in each block, were generated by the Online Randomizer website (www.sealesenvelop.com/simple randomizer).”
Allocation sequence random and probably concealed Some concerns no information if participants, carers aware of assigned intervention during the trial Low risk of bias data for this outcome available for all, or nearly all, participants randomized.
175Favipiravir and 178placebo
Some concerns per protocol analysis used Some concerns no information if outcomes were analysed in accordance with a pre‐specified analysis plan. protocol available but the analysis plan is unavailable. High risk of bias high risk