|Bias||Author's judgement||Support for judgement|
|Quote: " Patients were randomly assigned to treatment groups at a ratio of 2:2:1 (Figure 1)[...]At baseline, all groups were similar in terms of the frequency of pyrexia, peripheral SaO2, requirement for oxygen therapy at admission, and pulmonary CT score (Supplementary Table 1). Additionally, there were no significant differences among groups in the results on baseline laboratory tests, including levels of cytokines (IL-1, IL-2R, IL-6, IL-8, IL-10, TNF?), liver/cardiac enzymes, and SARS-CoV-2-specific IgG/IgM ( Supplementary Table 1 ). "
Comment: There was no information on whether the allocation sequence was concealed.
|Deviations from intervention||
|Comment: Unblinded study.
No participant cross-over.
No information on any co-interventions of interest were reported: antivirals, biologics, corticosteroids.
Data were analyzed using intention-to-treat analysis.
|Missing outcome data||
|Quote: "Seven patients in the chloroquine arm, 6 patients in the hydroxychloroquine arm, and 2 patients in the control arm were excluded from analysis because COVID-19 manifested as mild symptoms only. There were an additional 4 patients in the hydroxychloroquine arm who were misdiagnosed with COVID-19 and therefore excluded. 5 patients with no symptoms were also excluded (2 in the chloroquine arm and 3 in the hydroxychloroquine arm).
Comment: 67 patients randomized; 43 patients analyzed.
Data unavailable for more than 5% of those randomized. Missing data was a result of participants' health status (i.e. the true value of the outcomes assessed).
Risk assessed to be high for outcomes: Mortality. Adverse events. Serious adverse events.
|Measurement of the outcome||
|Comment: Outcome assessors were not blinded.
Mortality is an observer-reported outcome not involving judgement.
Risk assessed to be low for outcomes: Mortality.
Assessment of outcomes could have been influenced by knowledge of intervention as there are patient-reported elements
Risk assessed to be some concerns for outcomes: Adverse Events. Serious adverse events.
|Selection of the reported results||
|Comment: Neither the protocol nor the statistical analysis plan were available. The registry was available.
Mortality and Adverse events were listed in the registry and reported as such in the paper.
Results were not selected from multiple outcome measurements nor analyses of the data.
Trial analyzed as prespecified.
Risk assessed to be low for outcomes: Mortality. Adverse events. Serious adverse events.
|Overall risk of bias||