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c19early.org COVID-19 treatment researchTixagevimab/cilgavimabTixagev../c.. (more..)
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Tixagevimab/cilgavimab for COVID-19
12 studies from 250 scientists
27,448 patients in 3 countries
Statistically significant lower risk for hospitalization and cases.
6 studies from 6 independent teams in 2 countries show statistically significant improvements.
Efficacy is variant dependent.
COVID-19 Tixagevimab/cilgavimab studies. Sep 2023. c19early.org
0 0.5 1 1.5+ All studies 44% With exclusions 47% Mortality 36% Hospitalization 56% Cases 41% Viral clearance -24% RCTs 32% RCT mortality 29% Prophylaxis 52% Early -29% Late 30% Favorstixagevimab/ci.. Favorscontrol
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, and BQ.1.1 Planas. US EUA has been revoked. mAb use may create new variants that spread globally Focosi. mAb use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape Choudhary. Recent:
Desai
Din
Focosi.
Tixagevimab/cilgavimab has been officially adopted in 29 countries. Submit updates/corrections.
Sep 24
Covid Analysis Tixagevimab/cilgavimab for COVID-19: real-time meta analysis of 12 studies
Statistically significant lower risk is seen for hospitalization and cases. 6 studies from 6 independent teams in 2 countries show statistically significant improvements. • Meta analysis using the most serious outcome reported shows..
Sep 6
Desai et al., Crohn's & Colitis 360, doi:10.1093/crocol/otad047 Tixagevimab and Cilgavimab (Evusheld) as Pre-exposure Prophylaxis for COVID-19 in Patients With Inflammatory Bowel Disease: A Propensity Matched Cohort Study
12% lower hospitalization (p=0.81) and 35% more cases (p=0.18). TriNetX PSM retrospective 408 IBD patients receiving tixagevimab/cilgavimab and matched controls, showing no significant difference in COVID-19 cases or hospitalization.
Aug 10
Focosi et al., Drug Resistance Updates, doi:10.1016/j.drup.2023.100991 Analysis of SARS-CoV-2 mutations associated with resistance to therapeutic monoclonal antibodies that emerge after treatment
Review of reports of treatment-emergent resistance to COVID-19 monoclonal antibodies (mAbs), showing that some post-mAb treatment mutations appeared to spread globally soon after the mAb was introduced, raising concerns about transmission..
Aug 8
Din et al., Hemasphere, doi:10.1097/01.HS9.0000973036.97124.6c COVID-19 infection among CAR-T cell therapy recipients: A single center experience
19% lower hospitalization (p=0.77). Retrospective 64 COVID+ CAR-T cell therapy recipients, showing lower hospitalization with tixagevimab/cilgavimab prophylaxis in unadjusted results, without statistical significance.
May 12
Sindu et al., Transplantation Direct, doi:10.1097/txd.0000000000001485 Pre-exposure Prophylaxis with Tixagevimab-cilgavimab did not Reduce Severity of COVID-19 in Lung Transplant Recipients with Breakthrough Infection
96% higher ventilation (p=0.58), 210% higher ICU admission (p=0.33), 53% lower hospitalization (p=0.18), and 29% fewer symptomatic cases (p=0.14). Retrospective 546 lung transplant recipients, 203 receiving tixagevimab/cilgavimab, and 343 out of state or declining treatment, showing a trend towards lower incidence of cases, but no significant difference in clinical outcomes.
Jan 19
Lombardi et al., MDPI AG, doi:10.20944/preprints202301.0359.v1 Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients
368% higher mortality (p=0.32), 33% lower hospitalization (p=1), and 24% worse viral clearance (p=0.3). Retrospective immunocompromised patients, showing no significant difference between tixagevimab/cilgavimab and other mAbs.
Nov 22
2022
Levin et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac899 AZD7442 (Tixagevimab/Cilgavimab) for Post-exposure Prophylaxis of Symptomatic COVID-19
75% lower severe cases (p=0.33) and 42% fewer symptomatic cases (p=0.06). 1,121 patient PEP RCT showing lower symptomatic cases with tixagevimab/cilgavimab, without statistical significance.
Nov 17
2022
Planas et al., bioRxiv, doi:10.1101/2022.11.17.516888 Resistance of Omicron subvariants BA.2.75.2, BA.4.6 and BQ.1.1 to neutralizing antibodies
In Vitro study suggesting a lack of efficacy for tixagevimab/vilgavimab with BA.2.75.2, BQ.1.1, and BA.4.6.
Oct 31
2022
Najjar-Debbiny et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac855 Effectiveness of Evusheld in Immunocompromised Patients: Propensity Score-Matched Analysis
59% lower hospitalization (p=0.02) and 25% fewer cases (p=0.03). Retrospective 732 immunocompromised patients in Israel treated with tixagevimab/cilgavimab, and 2,812 matched controls, showing significantly lower cases and hospitalization with treatment.
Jul 29
2022
Kertes et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac625 Association between AZD7442 (tixagevimab-cilgavimab) administration and SARS-CoV-2 infection, hospitalization and mortality
92% lower combined mortality/hospitalization (p=0.01) and 47% fewer cases (p=0.01). 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
2022
Holland et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00215-6 Tixagevimab–cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial
30% lower mortality (p=0.03) and 7% improved recovery (p=0.21). RCT with 710 hospitalized patients treated with tixagevimab/cilgavimab, and 707 placebo patients, showing lower mortality with treatment.
Jun 7
2022
Montgomery et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(22)00180-1 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
no change in mortality (p=1), 50% lower severe cases (p=0.01), and 57% lower hospitalization (p=0.002). RCT 910 outpatients in the USA, 456 treated with tixagevimab/cilgavimab, showing significantly lower combined severe COVID-19/death with treatment.
May 29
2022
Young-Xu et al., medRxiv, doi:10.1101/2022.05.28.22275716 Tixagevimab/Cilgavimab for Prevention of COVID-19 during the Omicron Surge: Retrospective Analysis of National VA Electronic Data
64% lower mortality (p=0.004), 69% lower combined death/hospitalization/cases (p<0.0001), 87% lower hospitalization (p=0.04), and 66% fewer cases (p=0.03). PSM retrospective 1,848 immunocompromised patients given tixagevimab/cilgavimab prophylaxis, showing lower mortality, hospitalization, and cases.
Apr 20
2022
Levin et al., New England Journal of Medicine, doi:10.1056/NEJMoa2116620 Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19
86% lower mortality (p=0.11) and 82% fewer symptomatic cases (p<0.0001). PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment.
Dec 8
2021
FDA Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab)
40% fewer symptomatic cases (p=0.07). 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
Levin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1646 PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults
86% lower mortality (p=0.11) and 76% fewer symptomatic cases (p=0.0005). 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 [fda.gov].
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, 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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