The CDC released some updates on COVID-19 vaccines.
Lilly announced that in the 965 patient, Phase III, BLAZE-2 prevention trial (NCT04497987), fewer patients and staff that received bamlanivimab 4,200 mg developed COVID-19 than patients and staff who received placebo in 299 residents and 666 staff at skilled nursing and assisted living facilities. A pre-specified subgroup of residents had an 80% lower risk of testing positive for COVID-19 compared to residents in the same facility that received placebo. No deaths were reported in residents that received bamlanivimab compared to four that received placebo.
Final results from 577 patients enrolled in the 11-day, dose-ranging, Phase II portion of the BLAZE-1 trial (NCT04427501), that received bamlanivimab alone (700mg, 2,800mg or 7000mg) did not decrease viral load by day 11 compared to placebo in non-hospitalized patients with mild to moderate COVID-19. The full data set for the placebo groups was not available for the interim analysis, which may explain the difference in outcomes with the final analysis. However, the combination of bamlanivimab 2800 mg and etesevimab 2800 mg decreased the viral load compared to placebo. The combination group was also the only one that had a significant decrease in COVID-19 related hospitalizations or emergency department visits at day 29.
In the 15-day, 129 patient, Phase III, TOCIBRAS trial (NCT04403685), treatment with tocilizumab did not reduce a composite of death or mechanical ventilation (28% vs 20%) compared to placebo in patients with COVID-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (C reactive protein, D dimer, lactate dehydrogenase, or ferritin). At 15-days, mortality was higher with tocilizumab compared to placebo (17% vs 3%), but the difference was no longer significant at day 29.
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