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PrEP |
Lilly, Press Release (Preprint) |
symp. case, ↓57.0%, p=0.0002 |
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents |
Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment. |
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Pre-Exposure Prophylaxis study
Pre-Exposure Prophylaxis study
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Lilly, Press Release (Preprint) |
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents |
Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment.
risk of symptomatic case, 57.0% lower, RR 0.43, p < 0.001, treatment 483, control 482, group sizes estimated because they were not supplied.
risk of symptomatic case, 80.0% lower, RR 0.20, p < 0.001, treatment 150, control 149, nursing home residents, group sizes estimated because they were not supplied.
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Early |
Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 (Peer Reviewed) |
hosp./ER, ↓70.6%, p=0.05 |
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 |
RCT for LY-CoV555 monotherapy and LY-CoV555/LY-CoV016 combination therapy with 592 patients showing lower hospitalization/ER visits with treatment.
For viral load at day 11, a statistically significant reduction was found with combinatio.. |
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Early treatment study
Early treatment study
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Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 (Peer Reviewed) |
Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19 |
RCT for LY-CoV555 monotherapy and LY-CoV555/LY-CoV016 combination therapy with 592 patients showing lower hospitalization/ER visits with treatment.For viral load at day 11, a statistically significant reduction was found with combination therapy but not monotherapy.
risk of hospitalization/ER, 70.6% lower, RR 0.29, p = 0.05, treatment 4 of 101 (4.0%), control 7 of 52 (13.5%), LY-CoV555 all dosages.
risk of hospitalization/ER, 79.9% lower, RR 0.20, p = 0.13, treatment 1 of 37 (2.7%), control 7 of 52 (13.5%), LY-CoV555 700mg.
risk of hospitalization/ER, 75.2% lower, RR 0.25, p = 0.25, treatment 1 of 30 (3.3%), control 7 of 52 (13.5%), LY-CoV555 2800mg.
risk of hospitalization/ER, 56.3% lower, RR 0.44, p = 0.31, treatment 2 of 34 (5.9%), control 7 of 52 (13.5%), LY-CoV555 7000mg.
risk of hospitalization/ER, 91.8% lower, RR 0.08, p = 0.04, treatment 0 of 31 (0.0%), control 7 of 52 (13.5%), continuity correction due to zero event, LY-CoV555/LY-CoV016.
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Late |
ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 (Peer Reviewed) |
death, ↑100%, p=0.22 |
A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 |
Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555. |
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Late treatment study
Late treatment study
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ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 (Peer Reviewed) |
A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19 |
Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555.
risk of death, 100% higher, RR 2.00, p = 0.22, treatment 9 of 163 (5.5%), control 5 of 151 (3.3%), adjusted, proportional hazards regression.
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Early |
Chen et al., NEJM, doi:10.1056/NEJMoa2029849 (Peer Reviewed) |
hosp., ↓74.3%, p=0.02 |
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 |
Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo.
NCT04427501 |
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Early treatment study
Early treatment study
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Chen et al., NEJM, doi:10.1056/NEJMoa2029849 (Peer Reviewed) |
SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19 |
Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo.NCT04427501
risk of hospitalization, 74.3% lower, RR 0.26, p = 0.02, treatment 5 of 309 (1.6%), control 9 of 143 (6.3%).
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News |
Lilly (News) |
news |
Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial |
ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing. |
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News
News
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Lilly (News) |
Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial |
ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing.
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Early |
Lilly (Preprint) |
hosp., ↓84.5%, p=0.05 |
SARS-CoV-2 neutralizing antibody program update |
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 .. |
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Early treatment study
Early treatment study
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Lilly (Preprint) |
SARS-CoV-2 neutralizing antibody program update |
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).NCT04427501
risk of hospitalization or ER visit, 84.5% lower, RR 0.15, p = 0.05, treatment 112, control 156.
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