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Tixagevimab/cilgavimab COVID-19 studies. Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2, however show significant efficacy with omicron. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape. Recent:
Kertes
Holland
Montgomery
Young-Xu
Levin.
Tixagevimab/cilgavimab has been officially adopted for early treatment in 2 countries. Submit updates/corrections.
Aug 12
Early, Late, PrEP, PEP Covid Analysis (Preprint) (meta analysis)
meta-analysis
Tixagevimab/cilgavimab for COVID-19: real-time meta analysis of 6 studies
Details   • Statistically significant improvements are seen for mortality, hospitalization, and cases. 5 studies from 5 independent teams in 2 different countries show statistically significant improvements in isolation (3 for the most serious outc..
Jul 29
PrEPPEP Kertes et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac625
death/hosp., ↓91.9%, p=0.01
Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality
Details   Retrospective 825 immunocompromised individuals treated with tixagevimab-cilgavimab and 4229 untreated in Israel, showing significantly lower infection and hospitalization/death with treatment. Omicron was the dominant variant.
Jul 8
Late Holland et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00215-6
death, ↓30.0%, p=0.03
Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial
Details   RCT with 710 hospitalized patients treated with tixagevimab/cilgavimab, and 707 placebo patients, showing lower mortality with treatment.
Jun 7
Early Montgomery et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00180-1
death, ↓0.2%, p=1.00
Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial
Details   RCT 910 outpatients in the USA, 456 treated with tixagevimab/cilgavimab, showing significantly lower combined severe COVID-19/death with treatment.
May 29
PrEPPEP Young-Xu et al., medRxiv, doi:10.1101/2022.05.28.22275716 (Preprint)
death, ↓64.0%, p=0.004
Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA Electronic Data
Details   PSM retrospective 1,848 immunocompromised patients given tixagevimab/cilgavimab prophylaxis, showing lower mortality, hospitalization, and cases.
Apr 20
PrEPPEP Levin et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116620
death, ↓85.7%, p=0.11
Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19
Details   PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment.
Dec 8
2021
PrEPPEP FDA (Preprint)
symp. case, ↓39.5%, p=0.07
Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab)
Details   PEP RCT with 749 tixagevimab/cilgavimab patients and 372 control patients, showing lower risk of symptomatic cases with treatment, without statistical significance. STORM CHASER. NCT04625972.
Dec 8
2021
PrEPPEP Levin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1646 (Preprint)
death, ↓85.7%, p=0.11
PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults
Details   PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment. Followup data is from .
Please send us corrections, updates, or comments. Vaccines and treatments are both valuable and complementary. All practical, effective, and safe means should be used. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. Denying the efficacy of any method increases mortality, morbidity, collateral damage, and the risk of endemic status. 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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