| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: “Participants were randomly assigned to Lambda or placebo using a 1:1 REDCAP-based computer-generated randomization scheme that stratified by age ( 50 and < 50 years old) and sex. A password-protected electronic spreadsheet containing the randomization allocation, along with the code used to generate the allocation and seed used in the random number generation, was stored on secure servers at Stanford.” "The study medication/placebo syringe was dispensed by the Stanford Investigational Pharmacist"
Comment: Allocation sequence random. Allocation concealment probably concealed. |
| Deviations from intervention |
Low |
Quote: "single-blind" "Lambda and placebo syringes were identically labeled but differed in the appearance of the needle hub. Since the nurse administering the medication might see syringe differences, the study was not strictly “double-blind” even though all participants and investigators were blinded to treatment arm."
Comment: It is unlikely that this lack of blinding (of the study nurse) would have led to deviations (by patients or staff) from the intended intervention. Data were analyzed using intention-to-treat analysis. |
| Missing outcome data |
Low |
Comment: 120 patients randomized; 120 patients analyzed.
Data available for all participants. Risk assessed to be low for the outcomes: Time to viral negative conversion. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Low |
Quote: "Lambda and placebo syringes were identically labeled but differed in the appearance of the needle hub. Since the nurse administering the medication might see syringe differences, the study was not strictly “double-blind” even though all participants and investigators were blinded to treatment arm."
Comment: Outcome assessor was probably blinded.. Risk assessed to be low for the outcomes: Time to viral negative conversion. Adverse events. Serious adverse events. |
| Selection of the reported results |
Some concerns |
Comment: The trial registry but not the protocol or statistical analysis plan was available at the time of data collection.
Time to viral negative conversion was analyzed as specified in the trial register. All secondary outcomes were added to the trial registration after completion of study recruitment and follow up, but this does not affect the outcomes extracted. Result was not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for outcome: Time to viral negative conversion. Adverse events and Serious adverse events were not listed as outcomes in the trial registry. No information on whether the results were selected from multiple outcome measurements or analyses of the data. Risk assessed to be some concerns for the outcomes: Adverse events. Serious adverse events. |
| Overall risk of bias |
Some concerns |