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: “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. Unclear allocation concealment. |
| Deviations from intervention |
Low |
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. Information on administration of co-interventions of interest: no biologics, antivirals or corticosteroids were administered (obtained from contact with authors). MORTALITY, CLINICAL IMPROVEMENT, AE, SAE Hence, deviations did not arise because of the trial context Our analysis for the outcome is an intention-to-treat analysis. This method was considered appropriate to estimate the effect of assignment to intervention. Risk assessed to be low for the outcomes: Mortality (D28). Time to clinical improvement. Clinical improvement (D28). Adverse events. Serious adverse events. VIRAL NEGATIVE CONVERSION Participants were analyzed according to their randomized groups for the outcome. Of note, 0 vs 1 participant was excluded from the analysis post-randomization for unknown reasons likely due to missing data which is accounted for in domain 3. This method was considered appropriate to estimate the effect of assignment to intervention for this outcome. Risk assessed to be low for the outcomes: Incidence of viral negative conversion (D7). |
| Missing outcome data |
Low |
Comment: 61 participants randomized; 59 participants analyzed for all efficacy outcomes except viral negative conversion (60 participants analyzed). For safety outcomes, 61 participants analyzed (from contact with authors).
Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). Clinical improvement (D28). Time to clinical improvement. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Quote: "Masking/Blinding used Outcome Assessors" (registry)
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). Time to clinical improvement. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: Protocol and statistical analysis plan were not available and registry was retrospective (dated 19 August 2021).
MORTALITY, VIRAL NEGATIVE CONVERSION, CLINICAL IMPROVEMENT Outcome not pre-specified 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). TIME TO CLINICAL IMPROVEMENT, AE, SAE Outcome data acquired from direct contact with authors. Analysis performed by the COVID-NMA. Risk assessed to be low for the outcome: Time to clinical improvement. Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |