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: "An independent biostatistician from the Indian Council
Medical Research-National Institute of Epidemiology,
Chennai, India, generated the randomisation
sequence using the RALLOC module in STATA v.14
(College Station, TX). A stratified block randomisation
strategy was used to allocate participants in a 1:1 ratio
to receive either convalescent plasma with the best
standard of care (intervention arm) or best standard
of care alone (control arm). Stratification was by
sites; block randomisation was done with unequal
block sizes. After written, informed consent had been
obtained from eligible patients, the site investigators
screened the participants for recruitment and
contacted a member of the central trial coordinating
team to receive the randomisation sequence, ensuring
concealment of allocation"
Comment: Allocation sequence random. Allocation sequence concealed. There were baseline imbalances in diabetes, however, logistic regression done for diabetes. |
| Deviations from intervention |
Some concerns |
Quote: "open label"
Comment: Unblinded study (participants and personnel/carers). Deviations from intended intervention arising because of the study context: Cross over: 3 participants in the control group received intervention (Convalescent Plasma). Deviation too small to affect the outcome. Administration of co-interventions of interest were reported and balanced: antivirals, corticosteroids, biologics. Hence, deviations did not arise because of the trial context. MORTALITY 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 outcome: Mortality (D28). VIRAL NEGATIVE CONVERSION Participants were analyzed according to their randomized groups for the outcome. Of note, 62 vs 60 participants were excluded from the analysis post-randomization due to missing data which is accounted for in domain 3. 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 outcome: Incidence of viral negative conversion (D7). |
| Missing outcome data |
Some concerns |
Comment: 464 participants analyzed, 464 participants analyzed for mortality, 342 analyzed for viral negative conversion.
Data available for all or nearly all participants for mortality Risk assessed to be low for outcome: Mortality (D28). Data not available for all or nearly all participants for outcome viral negative conversion Reason: unclear based on the flow-chart No information on whether missingness could depend on the true value of the outcome. Not likely that missingness depended on the true value of the outcome (similar proportion of missingness between arms). Risk assessed to be some concerns for outcomes: Incidence of viral negative conversion (D7). |
| Measurement of the outcome |
Low |
Comment: Method of measuring the outcome probably appropriate.
Measurement or ascertainment of outcome probably does not differ between groups. Unblinded study (outcome assessor) Mortality and viral negative conversion are observer-reported outcomes, not involving judgement. Risk assessed to be low for the outcomes: Mortality (D28). Incidence of viral negative conversion (D7). |
| Selection of the reported results |
Some concerns |
Comment: Neither the protocol or statistical analysis plan were available. Registry was available.
The outcome mortality was registered and reported in the publication with appropriate time points. Result was not selected from multiple outcome measurements nor multiple analyses of the data. Trial analyzed as pre specified. Risk assessed to be low for the outcome: Mortality (D28). Viral negative conversion was not specified in the registry, but was reported in the publication. Result was not selected from multiple outcome measurements nor multiple analyses of the data. Trial not analyzed as pre specified. Risk assessed to be some concerns for the outcome: Incidence of viral negative conversion (D7). |
| Overall risk of bias |
Some concerns |