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 |
High |
Quote: "Patients randomized classification into standard treatment group and case group was performed using permuted block randomization. In this study, four-unit blocks were used. Using R software, a chain of randomized numbers comprising one to six are created to reach the desired sample size." No allocation concealment, based on author reply.
Comment: Allocation sequence random. Allocation sequence not concealed. |
| Deviations from intervention |
Low |
Quote (protocol): “This study is designed double-blinded (patients and physicians).”
Comment: Blinded study (participants and personnel/carers) Based on author's reply, there were not deviations from intervention and all patients were analyzed according to their randomized groups. 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 low for the outcomes: Mortality (D28).Incidence of viral negative conversion (D7). Time to death. Time to clinical improvement. WHO score 7 and above (D28). |
| Missing outcome data |
Low |
MORTALITY, TIME TO DEATH, INCIDENCE OF VIRAL NEGATIVE CONVERSION, WHO SCORE 7 AND ABOVE Comment: 120 participants randomized; 120 participants analyzed. Data available for all or nearly all participants randomized. Risk assessed to be low for the outcomes: Mortality (D28).Time to death. Incidence of viral negative conversion (D7). WHO score 7 and above (D28). TIME TO CLINICAL IMPROVEMENT Comment: 89 hospitalized participants randomized; 89 hospitalized participants analyzed. Data available for all or nearly all participants randomized. Risk assessed to be low for the outcome: Time to clinical improvement. |
| Measurement of the outcome |
Low |
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). Time to death. Time to clinical improvement.WHO score 7 and above (D28) |
| Selection of the reported results |
Some concerns |
Comment: The protocol and statistical plan (no date provided), and the retrospective registry (dated September 9th, 2020) were available .
MORTALITY, TIME TO DEATH, TIME TO CLINICAL IMPROVEMENT No information on whether the result was selected from multiple outcome measurements or analyses of the data. Trial probably not analyzed as pre-specified. Risk assessed to be some concerns for the outcome: Mortality (D28). Time to death. Time to clinical improvement. INCIDENCE OF VIRAL NEGATIVE CONVERSION, WHO SCORE 7 AND ABOVE Outcome data acquired from contact with authors. Results were probably not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcome: Incidence of viral negative conversion (D7).WHO score 7 and above (D28). |
| Overall risk of bias |
High |