LY-CoV for COVID-19: real-time analysis of all 5 studies

LY-CoV555 and LY-CoV016 are two SARS-CoV-2 neutralizing antibodies which bind complementary regions of the SARS-CoV-2 spike protein. Studies are investigating their use in monotherapy and in combination. Submit updates/corrections below.


1/21	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.
1/21	Details Source PDF Pre-Exposure Prophylaxis study Pre-Exposure Prophylaxis study
	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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1/21	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..
1/21	Details Source PDF Early treatment study Early treatment study
	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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12/22	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.
12/22	Details Source PDF Late treatment study Late treatment study
	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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10/28	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
10/28	Details Source PDF Early treatment study Early treatment study
	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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10/26	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.
10/26	Details Source PDF News News
	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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10/7	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 ..
10/7	Details Source PDF Early treatment study Early treatment study
	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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