| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "Participants were randomized by the Penn Investigatio*l Drug Service (IDS) using a randomization software. The IDS staff kept the randomization assignments concealed from study staff and investigators until interim a*lyses." Comment: Allocation sequence random. Allocation sequence concealed. |
| Deviations from intervention |
Low |
Quote: "A double-blind, placebo-controlled clinical trial."
Comment: Blinded study (particpants and investigators) Data were a*lyzed using intention-to-treat a*lysis. |
| Missing outcome data |
Low |
Comment: 132 patients randomized; 125 patients a*lyzed for primary outcome and 130 for adverse events.
Data available for 95% of population Risk assessed to be low for outcomes: Incidence of COVID-19 confirmed by RT-PCR. Incidence of hospital admission or death. Incidence of ICU admission or death. Mortality. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Comment: Blinded study (outcome assessor)
Risk assessed to be low for outcomes: Incidence of COVID-19 confirmed by RT-PCR. Incidence of hospital admission or death. Incidence of ICU admission or death. Mortality. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: The protocol and statistical a*lysis plan were available.
Data a*lyzed and presented as pre-specified. Risk assessed to be low for outcomes: Incidence of COVID-19 confirmed by RT-PCR. Incidence of hospital admission or death. Incidence of ICU admission or death. Mortality. Adverse events. Serious adverse events. |
| Overall risk of bias |
Low |