Interim results from the BLAZE-1 outpatient RCT showing improvements in viral load, symptoms and hospitalization.
Combination therapy significantly reduced viral load at day 11 (p
=0.011). A greater effect is seen at day 7 (p
<0.001). The proportion of patients with persistent high viral load at day 7 for combination therapy was lower (3.0 percent) versus placebo (20.8 percent), corresponding to a nominal p value of p
<0.0001 without multiplicity adjustment. No emergent putative resistance variants have been observed thus far in patients treated with combination therapy.
The rate of COVID-related hospitalization and ER visits was lower for patients treated with combination therapy (0.9 percent) versus placebo (5.8 percent), a relative risk reduction of 84.5 percent (p
=0.049). This was also similar to observations for LY-CoV555 monotherapy.
Combination therapy has been generally well tolerated with no drug-related serious adverse events. In LY-CoV555 monotherapy studies there have been isolated drug-related infusion reactions or hypersensitivity that were generally mild (two reported as serious infusion reactions, all patients recovered).
Lilly et al., 10/7/2020, Randomized Controlled Trial, USA, North America, preprint, 1 author.
risk of hospitalization or ER visit, 84.5% lower, RR 0.15, p = 0.05, treatment 112, control 156.
Effect extraction follows pre-specified rules
prioritizing more serious outcomes. For an individual study the most serious
outcome may have a smaller number of events and lower statistical signficance,
however this provides the strongest evidence for the most serious outcomes
when combining the results of many trials.