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|
|Quote: “A standard clinical pharmacological randomization tool was applied. Sequential patients were assigned by chance to one of 2 treatments, A, B. Patients were asked to select from a pot of rolled papers labelled A or B. The numbers of A = B. This sequence was followed until the sample of 30/31 was attained in each of the 2 groups.”
Comment: Allocation sequence probably random. Allocation sequence probably concealed.
|Deviations from intervention||
|Quote: "This was designed as a single-blind trial" (report) "Masking/Blinding used Outcome Assessors" (registry)
Comment: Unblinded study (participants and personnel/carers)
Deviations from intended intervention arising because of the study context:
No participant cross-over reported.
No information on administration of co-interventions of interest: biologics, antivirals and corticosteroids.
Hence, no information on whether deviations arose because of the trial context.
Our analysis for the binary outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention.
Of note, 4 participants in the three-drug arm were excluded from the analysis post-randomization because they had an allergic reaction to HCQ that did not respond to treatment. This method was considered inappropriate to estimate the effect of assignment to intervention for this outcome. There was probably no substantial impact of failure to analyze participants according to their randomized groups.
Risk assessed to be some concerns for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28).
|Missing outcome data||
|Comment: Unclear number of participants randomized; up to 61 participants analyzed.
No information on whether data were available for all randomized participants.
No evidence that the result is not biased.
No information on whether missingness could or is likely to depend on the true value of the outcome.
Risk assessed to be high for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28).
|Measurement of the outcome||
|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 outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28).
|Selection of the reported results||
|Comment: Protocol and statistical analysis plan were not available and registry was retrospective (dated 19 August 2021).
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 outcome: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28).
|Overall risk of bias||