Bamlanivimab for COVID-19: real-time analysis of all 8 studies

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Database of all bamlanivimab COVID-19 studies. Submit updates/corrections.


Jun 23	Early	Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331 (Peer Reviewed)	death, ↓79.7%, p=0.09	Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19
	Details Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors falsely state that "no other COVID-19 therapies for ambulatory patients have pr..
Jun 23	Details Source PDF Early treatment study Early treatment study
	Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331 (Peer Reviewed)
	Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19
	Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors falsely state that "no other COVID-19 therapies for ambulatory patients have proven effective". risk of death, 79.7% lower, RR 0.20, p = 0.09, treatment 1 of 479 (0.2%), control 57 of 5,536 (1.0%). risk of hospitalization, 52.7% lower, RR 0.47, p < 0.001, treatment 22 of 479 (4.6%), control 538 of 5,536 (9.7%). Webb et al., 6/23/2021, retrospective, USA, North America, peer-reviewed, 14 authors.
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May 18	N/A	Focosi et al., Research Square, doi:10.21203/rs.3.rs-524959/v1 (Preprint)		Emergence of SARS-CoV-2 Spike Escape Mutation Q493r After Bamlanivimab/Etesevimab Treatment for COVID-19
	Details Case study showing that a mutation resistant to both bamlanivimab and etesevimab can arise in vivo. Authors note that accelerated evolution can occur under selective pressure from therapeutic interventions with neutralizing antibodies, an..
May 18	Details Source PDF N/A N/A
	Focosi et al., Research Square, doi:10.21203/rs.3.rs-524959/v1 (Preprint)
	Emergence of SARS-CoV-2 Spike Escape Mutation Q493r After Bamlanivimab/Etesevimab Treatment for COVID-19
	Case study showing that a mutation resistant to both bamlanivimab and etesevimab can arise in vivo. Authors note that accelerated evolution can occur under selective pressure from therapeutic interventions with neutralizing antibodies, and that bamlanivimab was withdrawn as a monotherapy because of failure against E484K-positive SARS-CoV-2 variants. Focosi et al., 5/18/2021, preprint, 7 authors.
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Mar 30	Late	Bariola et al., medRxiv, doi:10.1101/2021.03.25.21254322 (Preprint)	death, ↓66.8%, p=0.05	Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection
	Details Retrospective 234 patients receiving bamlanivimab and 234 matched controls, showing lower hospitalization and mortality with treatment. Greater benefit was seen with administration within 4 days of their positive COVID-19 test.
Mar 30	Details Source PDF Late treatment study Late treatment study
	Bariola et al., medRxiv, doi:10.1101/2021.03.25.21254322 (Preprint)
	Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection
	Retrospective 234 patients receiving bamlanivimab and 234 matched controls, showing lower hospitalization and mortality with treatment. Greater benefit was seen with administration within 4 days of their positive COVID-19 test. risk of death, 66.8% lower, RR 0.33, p = 0.05, treatment 4 of 234 (1.7%), control 12 of 234 (5.1%), OR converted to RR. risk of hospitalization, 60.7% lower, RR 0.39, p = 0.001, treatment 15 of 234 (6.4%), control 39 of 234 (16.7%), OR converted to RR. Bariola et al., 3/30/2021, retrospective, USA, North America, preprint, 22 authors.
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Mar 10	Early	Lilly, Press Release (Preprint)	death, ↓92.3%, p=0.01	Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19
	Details Results from the BLAZE-1 study of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment.
Mar 10	Details Source PDF Early treatment study Early treatment study
	Lilly, Press Release (Preprint)
	Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19
	Results from the BLAZE-1 study of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. risk of death, 92.3% lower, RR 0.08, p = 0.01, treatment 0 of 511 (0.0%), control 4 of 258 (1.6%), relative risk is not 0 because of continuity correction due to zero events. risk of combined hospitalization/death, 86.5% lower, RR 0.13, p < 0.001, treatment 4 of 511 (0.8%), control 15 of 258 (5.8%). Lilly et al., 3/10/2021, Double Blind Randomized Controlled Trial, USA, North America, preprint, 1 author.
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Jan 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
	Details Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment.
Jan 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. Lilly et al., 1/21/2021, Randomized Controlled Trial, USA, North America, preprint, 1 author.
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Jan 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
	Details 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..
Jan 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%), relative risk is not 0 because of continuity correction due to zero events, LY-CoV555/LY-CoV016. Gottlieb et al., 1/21/2021, Randomized Controlled Trial, USA, North America, peer-reviewed, 27 authors.
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Dec 22 2020	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
	Details Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555.
Dec 22 2020	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. ACTIV-3/TICO et al., 12/22/2020, Randomized Controlled Trial, USA, North America, peer-reviewed, 1 author.
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Oct 28 2020	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
	Details 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
Oct 28 2020	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%). Chen et al., 10/28/2020, Randomized Controlled Trial, USA, North America, peer-reviewed, 12 authors.
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Oct 26 2020	News	Lilly, Press Release (News)	news	Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial
	Details ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing.
Oct 26 2020	Details Source PDF News News
	Lilly, Press Release (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. Lilly et al., 10/26/2020, preprint, 1 author.
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Oct 7 2020	Early	Lilly, Press Release (Preprint)	hosp., ↓84.5%, p=0.05	SARS-CoV-2 neutralizing antibody program update
	Details 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 ..
Oct 7 2020	Details Source PDF Early treatment study Early treatment study
	Lilly, Press Release (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. Lilly et al., 10/7/2020, Randomized Controlled Trial, USA, North America, preprint, 1 author.
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Please send us corrections, updates, or comments. Vaccines and treatments are both extremely valuable and complementary. All practical, effective, and safe means should be used. Elimination of COVID-19 is a race against viral evolution. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. Denying the efficacy of any method increases the risk of COVID-19 becoming endemic; and increases mortality, morbidity, and collateral damage. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. Treatment protocols for physicians are available from the FLCCC.

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Aspirin	Metformin
Bamlanivimab	Molnupiravir
Bromhexine	Nigella Sativa
Budesonide	Nitazoxanide
Casirivimab/i..	Povidone-Iod..
Colchicine	Probiotics
Conv. Plasma	Proxalutamide
Curcumin	Quercetin
Favipiravir	Remdesivir
Fluvoxamine	Sotrovimab
Hydroxychloro..	Vitamin A
Iota-carragee..	Vitamin C
Ivermectin	Vitamin D
Melatonin	Zinc

Other	Adoption