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).
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron1-5.
Standard of Care (SOC): SOC for COVID-19 in the study country,
the USA, is
very poor with
very low average efficacy for approved treatments
6.
Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
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risk of hospitalization or ER visit, 84.5% lower, RR 0.15, p = 0.049, treatment 112, control 156.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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4.
Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines,
doi:10.3390/vaccines11101533.mdpi.com, doi.org.
Lilly et al., 7 Oct 2020, Randomized Controlled Trial, USA, preprint, 1 author, trial
NCT04427501 (history).
