Bias | Author's judgement | Support for judgement |
Randomization |
Low |
Quote: "Hospitalized patients with Covid-19 were randomly
assigned in a 1:1 ratio to receive either
LY-CoV555 or matching placebo. In addition, all
the patients received high-quality supportive care
as background therapy, including remdesivir and,
when indicated, supplemental oxygen and glucocorticoids.
Randomization was stratified according
to the trial pharmacy, since each pharmacy
could serve more than one trial site. LY-CoV555
or placebo was administered as a single intravenous
infusion over a 1-hour period. The infusion
was prepared by trial pharmacists. All other personnel,
including investigators and research staff,
clinical staff, and patients, were unaware of the
trial-group assignments."
Comment: Allocation sequence random. Allocation sequence concealed. Imbalances in baseline characteristics appear to be compatible with chance. |
Deviations from intervention |
Low |
Quote (report): “The infusion was prepared by trial pharmacists. All other personnel, including investigators and research staff, clinical staff, and patients, were unaware of the trial-group assignments.”
Quote (protocol): “blinding of the participant and clinical staff will be achieved by placing a colored sleeve over the infusion bags used for investigational agents and placebos” Comment: Blinded study (patients and physicians). Data were analyzed using modified intention-to-treat analysis (a small proportion not included was randomized on day of termination and never received treatment or follow up) which is appropriate to assess the effect of assignment to intervention. |
Missing outcome data |
Low |
Comment: 326 patients randomized; 314 patients analyzed.
Data available for >95% of population. Risk assessed to be low for the outcomes: Mortality. Time to death. Clinical improvement. Time to clinical improvement. WHO score 6 and above. WHO score 7 and above. Serious adverse events. |
Measurement of the outcome |
Low |
Comment: Blinded study (outcome assessor).
Risk assessed to be low for the outcomes: Mortality. Time to death. Clinical improvement. Time to clinical improvement. WHO score 6 and above. WHO score 7 and above. Serious adverse events. |
Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan and trial registry were available.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. Time to death. Clinical improvement. Time to clinical improvement. WHO score 6 and above. WHO score 7 and above. Serious adverse events. |
Overall risk of bias |
Low |