| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "An independent statistician prepared an electronically generated randomization list with 14 blocks of 30 participants per block, generated via R software version 3.6.1 (Blockrand package). The list was accessible only to non-blinded pharmacists in the study. Participants were randomized by the study pharmacist to their designated treatment regimen at the time of inclusion and were subsequently identified throughout the study only by their allocated study number". Comment: Any imbalance in the baseline characteristics is compatible with chance. |
| Deviations from intervention |
Low |
Comment: Double-blinded study.
Outcome data were analyzed using modified intention-to-treat and intention-to-treat analyses. |
| Missing outcome data |
High |
Comment: Intervention arm: 209 randomized used in ITT analysis, 194 analysed in mITT analysis
Control arm: 207 randomized used in ITT analysis, 199 analysed used mITT analysis. Missingness due to documented reasons unrelated to the outcome: 4 ICF withrawals before treatment, 4 ICF withdrawals after treatment, 2 protocol deviations (previous steroid use). Missingness that could depend on its true value (1 referral to a different hospital, 1 medical discretion, 11 deaths) occurred in <5% of population. Denominator for viral negative conversion D7 is 117 for the intervention arm and 95 for control arm. However, 161 patients in intervention arm and 157 patients in control arm were positive at baseline. Risk assessed to be low for the outcomes: Mortality. Time to death. Risk assessed to be high for the outcomes: Incidence of viral negative conversion |
| Measurement of the outcome |
Low |
Comment: Mortality and Neg Conv is an observer-reported outcome not involving judgement. Risk assessed to be low for outcomes: Mortality. Time to death. Incidence of viral negative conversion |
| Selection of the reported results |
Low |
Comment: Protocol and statistical plan available. Data analysed and presented according to a pre-specified plan. Risk assessed to be low for the outcomes: Mortality. Time to death. Incidence of viral negative conversion. |
| Overall risk of bias |
High |