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All Studies   Meta Analysis       

SARS-CoV-2 neutralizing antibody program update

Lilly, Press Release, NCT04427501
Oct 2020  
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Hospitalization or ER visit 84% Improvement Relative Risk Bamlanivimab/e..  Lilly et al.  EARLY TREATMENT  RCT Is early treatment with bamlanivimab/etesevimab beneficial for COVID-19? RCT 268 patients in the USA Fewer hosp./ER visits with bamlanivimab/etesevimab (p=0.049) c19early.org Lilly, Press Release, October 2020 Favorsbamlanivimab/e.. Favorscontrol 0 0.5 1 1.5 2+
22nd treatment shown to reduce risk in May 2021, now with p = 0.00036 from 21 studies, recognized in 7 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
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.
risk of hospitalization or ER visit, 84.5% lower, RR 0.15, p = 0.049, treatment 112, control 156.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lilly et al., 7 Oct 2020, Randomized Controlled Trial, USA, preprint, 1 author, trial NCT04427501 (history).
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. 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. FLCCC and WCH provide treatment protocols.
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